louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00518739: MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)
Official title: A Phase I Dose Escalation Study of MK2461 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.


Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years of age, with adequate organ function, and an ECOG performance of \<2
* Patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during Part A)

Exclusion Criteria:

* No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
* Patients must not have primary central nervous system tumor
* Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication

Primary outcomes:
measure: To evaluate the safety and tolerability of MK2461
timeFrame: 18 Months
Secondary outcomes:
measure: To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics.
timeFrame: 18 Months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00258739: Docetaxel in Non Small Cell Lung Cancer (NSCLC)
Official title: A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

* To classify the 2 study groups, according to the tumoral response.

Secondary objectives:

* To evaluate the percentage of focused control per year.
* To calculate the time until progression.
* To evaluate the safety profile.


Eligibility criteria: Inclusion Criteria:

* Non small cell lung cancer confirmed by histology or by cytology.
* IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
* General stage 0-1 at the ECOG scale
* Loss of weight less than 5% in the 3 previous months from diagnose.
* Pulmonary function and gasometry results: FEV1 \> 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) \> 30%, PCO2 \< 45 mmHg and PO2 \> 60 mmHg.
* Normal medullar function (hemoglobin \> 11 g/dl, total WBC \> 1,5 x 10\^9/l, platelets \> 100 x 10\^9/l)
* Appropriate renal and hepatic functions
* CTScan
* Anticonceptive method
* Available laboratory test (maximum 1 month before)

Exclusion criteria:

* Pleural discharge, upper cava vein syndrome or supraclavicular affectation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Response rate in each arm measured according to RECIST criteria
timeFrame: Throughout the whole study
Secondary outcomes:
measure: Percentage of local-regional control within a year
timeFrame: Throughout the first year
measure: Time to progression defined as the period of time elapsed between the randomization date and the progression or death date
timeFrame: Throughout the whole study
measure: Toxicity measured by CALGB criteria and RTOG/EORTC criteria
timeFrame: Throughout the whole study
measure: Global surveillance measured as the period of time elapsed between randomization and death date.
timeFrame: Throughout the whole study duration
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: José Mª Taboada
role: STUDY_DIRECTOR
References:
Clinical trial NCT04756739: Menstrual Cycle Symptom Tracking
Official title: Menstrual Cycle Symptom Tracking Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Cycles
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, female volunteers

Brief summary: This study will provide menstrual cycle symptom information from women over the course of three menstrual cycles to determine whether there are any noticeable physiological changes that can be related to stage of the menstrual cycle or onset of menstruation.


Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18 years and over
* Regular menstrual cycles
* Owns a compatible smart phone i.e. iPhones® and AndroidTM phones equipped with Bluetooth® 4.0/BLE
* Willing to use their own smartphone for the duration of this study and to download and install the study app
* Willing to give informed consent

Exclusion Criteria:

* Currently trying to conceive
* Currently or recently pregnant or breastfeeding
* Taking any treatment which may affect the menstrual cycle (e.g. contraceptive pill, fertility medications or hormone replacement therapy)
* Taking or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)
* Has abnormal liver or kidney function
* Taking antibiotics containing tetracycline
* Taking clomiphene citrate or other ovulation induction drugs

Primary outcomes:
measure: Menstrual Cycle Symptoms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development Company
name: Sarah Johnson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06184139: Effect of Maternal Age and BMI on Induction of Labor Using Oral Misoprostol in Late-term Pregnancies: a Retrospective Cross-sectional Study
Official title: Effect of Maternal Age and BMI on Induction of Labor Using Oral Misoprostol in Late-term Pregnancies: a Retrospective Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Induction of Labor Affected Fetus / Newborn
Pregnancy Late
Keywords: Late-term pregnancy
body mass index
age
oral misoprostol
cervical ripening
induction of labor
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: term (37 weeks or more of gestation) singleton pregnancies in women who have not had a previous cesarean delivery and a bishop score \< 7.

Brief summary: To evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies.


Eligibility criteria: Inclusion Criteria:

* Late term pregnancies out of labor,
* Bishop score \< 7

Exclusion Criteria:

* labor (defined as presence of at least three painful uterine contractions every ten minutes),
* uterine tachysystole (\>5 contractions within 10 minutes for two consecutive 10-minute periods),
* hypertonic uterus,
* abnormal CTG,
* contraindications to vaginal delivery (fetal malpresentation such as breech presentation or transverse situation, fetal macrosomia, abnormally implanted placenta, active genital herpes infection, cervical cancer),
* patients with parity \> 4,
* medical contraindication to misoprostol (asthma, glaucoma),
* women with previous hysterotomies.

Primary outcomes:
measure: Safety and tolerability of misoprostol for induction of labor
timeFrame: 290 days of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Andrea Etrusco
Study officials:
References:
Clinical trial NCT01302639: Dietary Polyphenols and Lipid Oxidation
Official title: Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Alpro Foundation
First posted: 2011-02-24
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: There are strong indications that (combinations of) polyphenols may be attractive candidates in the prevention of the metabolic syndrome and diabetes through modulation of pathways of fatty acid metabolism and mitochondrial function. We hypothesize that the combination of specific polyphenols, with partly distinct mechanisms of action, may have physiologically significant effects on fat oxidation through additive or synergistic effects, thereby improving body composition, insulin sensitivity and preventing type 2 diabetes. The following objective will be addressed in the current study:

(1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG either in combination with resveratrol or with resveratrol and genistein) to affect systemic lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high fat meal in overweight subjects


Eligibility criteria: Inclusion Criteria:

* overweight men and women (BMI≥25kg/m2- 29.9 kg/m2), aged 30-70 years, Caucasian, normal fasting glucose (\< 6.1 mmol/L) and blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg), weight stable in last 3 months (± 2kg). Exclusion criteria:

Exclusion Criteria:

* women lactating, pregnant or (post)menopausal, regular smokers, people with intensive fitness training, eg. athletes (≥ 3 per week ≥ 1 hour training), habitual consumption of green tea (more than 1 cup per day) or products containing green tea extract, total caffeine consumption \> 300 mg/day, alcohol intake \>20 g/day, any dietary vitamins or dietary supplements, diabetes mellitus (defined as FPG ≥ 7.0 mmol/l and/or 2hPG ≥ 11.1 mmol/l); serious pulmonary, cardiovascular, hepatic or renal disease : history of cardiovascular disease, all other relevant medical disorders that potentially interfere with this trial, current use of medication interfering with study intervention or interfering with study endpoints/hypotheses.

Primary outcomes:
measure: postprandial fat oxidation
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
References:
citation: Most J, Goossens GH, Jocken JW, Blaak EE. Short-term supplementation with a specific combination of dietary polyphenols increases energy expenditure and alters substrate metabolism in overweight subjects. Int J Obes (Lond). 2014 May;38(5):698-706. doi: 10.1038/ijo.2013.231. Epub 2013 Dec 9.
Clinical trial NCT01643239: Effects of Forms of Modified CIT on Upper Extremity Performance in Cerebral Palsy
Official title: Effects of Forms of Modified Constraint-induced Therapy on Functional Performance of Upper Extremity in Children With Cerebral Palsy With Asymmetric Motor Impairments: A Follow up Study of Kinematic and Clinical Analyses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Modified constraint-induced therapy
Children with cerebral palsy
Kinematic analysis
Group therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung University
name: National Science and Technology Council, Taiwan
First posted: 2012-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will employ clinical assessment tools to examine the effects of modified constraint-induced therapy (mCIT) on the more affected upper extremity of children with cerebral palsy.

Detailed description: The study included threefold: (1) It will employ kinematic analysis, along with clinical assessment tools to examine the effects of mCIT on the more affected upper extremity of children with cerebral palsy with asymmetric motor impairments after treatment immediately and 1 year following. The clinical tools will include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP),Peabody-Developmental Motor Scales (PDMS-II), and Wee-FIM. (2) This study looked at the intervention impact on bimanual coordination and the less affected upper extremity. (3) It investigated the effects of forms (group vs. individual intervention) on upper extremity performance.

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of spastic CP
2. age between 4 and 10 years old
3. shoulder flexion of the affected upper limb more than 90 degrees, elbow extension over 160 degrees, wrist extension to 10 degrees at least, and fingers full flexion to 10 degrees at least
4. basic balance ability: sitting on the chair without arm support; feet stay on the floor consistently; performing the affected upper limb movement without losing balance
5. ability to follow simple oral commands
6. no related musculoskeletal surgery of the affected upper limb
7. not have injected the Botox into the affected upper extremity during the past 6 months
8. no visual or auditory disability

Primary outcomes:
measure: Kinematic assessment
timeFrame: up to six years
Secondary outcomes:
measure: Clinical measures at the motor quality and performance include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP), and Peabody-Developmental Motor Scales (PDMS-II)
timeFrame: up to six years
Other outcomes:
Locations:
city: Kwei-shan, Toayuan county
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Occupational Therapy, Chang Gung Univ.
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01826539: A Comparison of Dorsal Branch of the Digital Nerve Versus Dorsal Digital Nerve for Finger Pulp Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Defect of the Finger
Keywords: Dorsal digital nerve
dorsal branch of the digital nerve
dorsal branch of the digital artery
dorsal digital island flap
finger pulp defect.
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2013-04-08
Enrollment: 71
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.

Detailed description: The investigators compares two donor nerves attached with the flap for sensory reconstruction of finger pulp: the dorsal branch of the digital nerve and the dorsal digital nerve. The main outcomes were static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and cold intorlence of the reconstructed finger.

Eligibility criteria: Inclusion Criteria:

* The pulp or fingertip defect in only one finger
* A defect greater than or equal to 1.5 cm in length
* Necessity to preserve finger length
* A patient between 18 and 60 years of age

Exclusion Criteria:

* Injuries to the dorsum of the middle phalanx
* Injuries to the course of the vascular pedicle or donor nerve
* A defect less than 1.5 cm in length
* Multiple finger pulp defect
* Extremely contaminated wounds

Primary outcomes:
measure: static 2-point discrimination (2PD) test
timeFrame: 18 months to 26 months
Secondary outcomes:
measure: Cold intolerance
timeFrame: 18 months to 26 months
Other outcomes:
measure: Pain
timeFrame: 18 months to 26 months
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
affiliation: The Second Hospital of Tangshan
name: Dequn Liu, MD. PhD
role: STUDY_DIRECTOR
References:
citation: Chen C, Tang P, Zhang X. Use of the dorsal digital sensate free flap for reconstruction of volar soft tissue defect of digits. Ann Plast Surg. 2014 May;72(5):537-41. doi: 10.1097/SAP.0b013e318268a97f.
Clinical trial NCT00335439: Effect of Prophylactic Ketorolac on CME After Cataract Surgery
Official title: Effect of Prophylactic NSAID Drops on Cystoid Macular Edema After Cataract Surgery Using Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Edema, Cystoid
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2006-06-09
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.


Eligibility criteria: Inclusion Criteria:

* First cataract surgery (i.e., first eye).

Exclusion Criteria:

* hypersensitivity to the NSAID drug class,
* pregnancy.

Primary outcomes:
measure: Degree of cystoid macular edema by means of OCT (total macular volume) measurements
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Hotel Dieu Hospital, Kingston General Hospital, Queen's University
name: Sherif El-Defrawy, MD PhD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03792139: An Interaction Study of LY3200882 in Healthy Participants
Official title: Effects of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of LY3200882 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-01-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the effect of itraconazole on the amount of LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will occur up to 28 days prior to enrollment.


Eligibility criteria: Inclusion Criteria:

* Healthy males or postmenopausal females, as determined by medical history and physical examination

Exclusion Criteria:

* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing and during the study (with the exception of vitamins and occasional acetaminophen or ibuprofen, which will be permitted at the discretion of the investigator). Drugs that are known substrates, inducers, or inhibitors of CYP3A4 are specifically excluded within 30 days of dosing and throughout the study

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882
timeFrame: Baseline through 72 hours post-dose
measure: PK: Area Under the Concentration Curve (AUC) of LY3200882
timeFrame: Baseline through 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: