louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02856360: Changes in Footwear Comfort and Performance in High School Football Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot
Footwear
Keywords: Football
Cleats
Stiffness
Lead sponsor: High Point University
Sponsor class: OTHER
Collaborators: name: Adidas International, Inc.
First posted: 2016-08-04
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this proposal is to determine the effects of footwear stiffness on a large cohort of high school football players during a football season. The investigators expect that functional athlete groups will be developed, based on subject specific assessments (biomechanical, morphological, performance, comfort), and lead to important translational findings that may impact footwear modification and recommendation to a population of American football players. Two standard cleats will be randomized and provided during a season of high school football. Ratings of comfort, performance, and injury will be collected throughout the season.


Eligibility criteria: Inclusion Criteria:

* Participate on a club or school sponsored football team

Exclusion Criteria:

* Current injury that limits sport participation

Primary outcomes:
measure: Footwear comfort rating using a 100mm visual analog scale
timeFrame: 3 months
Secondary outcomes:
measure: Injury incidence
timeFrame: 3 months
Other outcomes:
Locations:
city: High Point
country: United States
facility: Human Biomechanics and Physiology Laboratory
state: North Carolina
Study officials:
References:
Clinical trial NCT01566760: A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
Official title: Open-Label, Single-Dose, Randomized, Crossover Study To Estimate The Effects Of Food On The Pharmacokinetics Of Two Fesoterodine Sustained-Release Beads-In-Capsule Formulations And To Estimate The Relative Bioavailability Of One Or Both Formulations Compared To Commercial Tablet Formulation In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Urinary Bladder, Overactive
Keywords: food effect
bioavailability
pharmacokinetics
fesoterodine
5-hydroxymethyl tolterodine
treatment of overactive bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between 21 and 55 years of age(inclusive).

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).

Primary outcomes:
measure: Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Secondary outcomes:
measure: Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05553860: Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances
Official title: Two Cohort Prospective Single Blinded Patient Crossover Trial Comparing Anterior Protrusive and Sibilant Phoneme Mandibular Positioning Techniques for Dental Sleep Appliances
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Occlusal Splints
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

Detailed description: Obstructive sleep apnea is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom-made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. Current methodology within dentistry is to position the mandible based on the person's maximum ability to position their mandible forward as the starting point and then slowly move the bottom jaw forward as necessary. Recent literature has shown that different mandibular positioning techniques may require less protrusion, less titrations, and potentially decreased side effects compared with the traditional protrusive techniques. One of the most promising techniques involves the use of speech to determine mandibular position. This technique would not require that a patient place their jaw outside of their normal functional range and could potentially decrease the face pain/jaw joint problems commonly associated with the use of oral sleep appliances for the treatment of obstructive sleep apnea. The use of speech as the determinant for where to position the mandible is important for muscular balance. Minimal research has been done in this area, with most studies being either retrospective or confounded by other variables. This will be the first prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

Eligibility criteria: Inclusion Criteria:

Patient diagnosed with obstructive sleep apnea, and

* Prescription/order for a dental sleep appliance
* 18 years or older
* Treatment planned in accordance with AADSM treatment guidelines

Exclusion Criteria:

* There are no separate exclusion criteria

Primary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: 3 months
Secondary outcomes:
measure: Overjet
timeFrame: 3 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Enoch Ng, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06283160: METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy
Official title: Interest of Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Duodenopancreatectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Fistula
Acute Pancreatitis
Pancreatoduodenectomy
Keywords: Metabolomics
Immune response
Pancreatic fistula
pancreatoduodenectomy
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be made of adult patients scheduled to undergo elective pancreaticoduodenectomy in the University hospital of Besançon (France)

Brief summary: Pancreatoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.

The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.

Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).


Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo elective pancreaticoduodenectomy
* Non-opposition of the subject to participate in the study.
* Affiliated to the French social security system (CMU included).

Exclusion Criteria:

* Emergent surgery.
* Pregnant patients.
* Refusal to participate or inability to provide informed consent.
* Patient under legal protection (individuals under guardianship by court order).

Primary outcomes:
measure: occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital of Besançon
Study officials:
References:
Clinical trial NCT01469260: Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women
Official title: Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight
Obesity
Pregnancy
Keywords: Overweight
Obesity
Pregnancy
Weight gain
Pedometer
Exercise
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Lucile Packard Children's Hospital
First posted: 2011-11-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate pedometer use by overweight women during pregnancy. The study will show if a pedometer will help women to limit weight gain during pregnancy. It will also show if it there are other benefits such as decreased diabetes, decreased high blood pressure, decreased rates of cesarean section, and decreased complications for the baby.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Pregnant
* Less than 16 weeks gestation
* Body mass index 25 or greater at first prenatal visit

Exclusion Criteria:

* History of spontaneous preterm delivery between 20-32 weeks gestation
* Medical contraindication to exercise or walking during pregnancy

Primary outcomes:
measure: Excessive gestational weight gain
timeFrame: At delivery
Secondary outcomes:
measure: Postpartum weight
timeFrame: 6 weeks postpartum
measure: Weight at 1 year postpartum
timeFrame: 1 year postpartum
measure: Gestational diabetes
timeFrame: During pregnancy
measure: Hemoglobin A1c
timeFrame: 24-28 weeks gestation
measure: Infant birth weight
timeFrame: At delivery
measure: Mode of delivery
timeFrame: At delivery
measure: Hypertensive disorders of pregnancy
timeFrame: During pregnancy
measure: Neonatal intensive care unit admission or neonatal complications
timeFrame: Up to 1 week after delivery
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Obstetrics Clinic
state: California
Study officials:
affiliation: Stanford University
name: Susan Crowe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Joyce Sung, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05378360: DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rash Acneiform
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708 for Treating Rash Acneiform

Detailed description: All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0

Eligibility criteria: Inclusion Criteria:

1. Age: older than 19
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
3. Patients who have Rash acneiform Gr≥2 (NCI CTCAE v5.0)
4. Patients who are currently administering EGFR TKI or EGFR mAb

Exclusion Criteria:

1. Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
2. Patients with a history of topical medication

   * Steroids within 3 days prior to baseline visit
   * Antihistamine, Antipruritic agents, Antibiotics agents within 1 week prior to baseline visit
   * Tacrolimus, Pimecrolimus within 2 weeks prior to baseline visit

Primary outcomes:
measure: To estimate the response rate of Rash acneiform
timeFrame: Up to 28 days
Secondary outcomes:
measure: To evaluate the patients' Quality of Life (QoL) by Skin evaluation method
timeFrame: Up to 56 days
measure: To estimate the amount of change papule and/or pustule
timeFrame: Up to 56 days
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
Study officials:
affiliation: Dong-A University Hospital
name: Sung Yong Oh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01327560: Sleep Quality and Related Factors in Hemodialysis Patients
Official title: Sleep Quality and Related Factors in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemodialysis-induced Symptom
Keywords: hemodialysis patients
sleep quality
restless legs syndrome
excessive daytime sleepiness
sleep apnea syndrome
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis Patients

Brief summary: Sleep quality is an important predictor of healthy status,quality of life and life span. Sleeping problems affect 50%\~80% in hemodialysis patients. Sleep quality and related factors research in hemodialysis patients has been discussed and studied globally. Previous studies show insomnia, excessive daytime sleepiness(EDS), sleep apnea syndrome(SAS), restless legs syndrome(RLS) are major causes of poor sleep quality . There is few data to show the influential factors related to sleep quality in Taiwanese hemodialysis patients.

Detailed description: This study will be a cross-sectional design with purposive sample from 2 different dialysis medical centers in Taipei. Two hundred hemodialysis patients meeting inclusion criteria will be recruited.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis patient whose age ≧ 20 years old and conscious clear.
* ICD9：585.6
* Every week receives two or three convention hemodialysis treatment above three months.
* May communication with Mandarin or Taiwanese language.
* Patient or caregiver is willing to participate study and sign the inform consent.

Exclusion Criteria:

* Hospitalized hemodialysis patient in recently one month.
* Hemodialysis patient had conscious disturbance, blind or dementia.
* Hemodialysis Patient refuse to interview or fill out questionnaires.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Tso-Hsiao Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636960: A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)
Official title: An Open-Label, Single-arm, Multicenter Phase I Study of SCH 54031 (Pegylated Interferon Alfa-2b) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (Protocol No. MK-4031 370 Also Known as SCH 54031, P08556)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Malignant Melanoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a weekly basis is safe and tolerated.

Detailed description: The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.

Eligibility criteria: Inclusion Criteria:

* Stage II or III melanoma
* Primary melanoma completely excised
* Full lymphadenectomy within 84 days prior to initiation of study treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Ocular melanoma or melanoma of the mucous membranes
* Evidence of distant or non-regional lymph node metastases
* In-transit melanoma
* Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy, radiotherapy or immunotherapy/vaccine for melanoma

Primary outcomes:
measure: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase
timeFrame: From first dose to end of induction phase; up to 8 Weeks
Secondary outcomes:
measure: Safety: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose through follow-up; up to 265 Weeks
measure: Number of Participants Discontinuing Study Drug Because of AEs
timeFrame: From first dose to last dose of treatment; up to 260 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Yamazaki N, Uhara H, Wada H, Matsuda K, Yamamoto K, Shimamoto T, Kiyohara Y. Phase I study of pegylated interferon-alpha-2b as an adjuvant therapy in Japanese patients with malignant melanoma. J Dermatol. 2016 Oct;43(10):1146-1153. doi: 10.1111/1346-8138.13338.
Clinical trial NCT06168760: Hand Dexterity and Anthropometric Measurement
Official title: The Relationship Between Finger-Hand Length And Hand Width With Dexterity In Healthy Individuals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anthropometric Measurement
Hand Dexterity
Keywords: anthropometric measurement
hand dexterity
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Subjects

Brief summary: This study aims to investigate the relationship between hand and finger lengths, hand width, and dexterity. The main question it aims to answer is:

1-Is there a relationship between anthropometric measurements of the hand and manual dexterity?

Detailed description: The hand is capable of performing complex specialized tasks that require dexterity, manipulation, and tactile sensitivity.(Polat, 2023) Hand performance on a task is a combination of different skills, including grip muscle strength, movement, tactile feedback, and motor coordination. (Imamura, Rissanen, Kinnunen, \& Rintamäki, 1998). To achieve these, the hand is equipped with mechanical and sensory abilities.(Dianat, Haslegrave, \& Stedmon, 2012) Dexterity is a motor skill determined by the range of motion of the hands and fingers, as well as the ability to manipulate. It is a combination of reaction time, touch sensation, nerve conduction, grip strength and mobility. While finger dexterity is related to the fine motor skills required to move relatively small objects, manual dexterity includes the gross motor skills required to hold relatively large objects.(Roman et al., 2023) The most common dexterity tests reported in the literature include the Box-Block Test, Purdue Pegboard Test, Jebsen Taylor Test, 9-Hole Peg Test (NHPT), and Roeder Manipulative Ability Test.

Eligibility criteria: Inclusion Criteria:

* Volunteers were included if they were 18 years of age or older and did not have any communication disorders

Exclusion Criteria:

* not having undergone any upper extremity surgery and not having a systemic disease

Primary outcomes:
measure: Hand Dexterity
timeFrame: Baseline and 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Ahi Evran University
Study officials:
References: