louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02958137: Arthroscopic Resection Arthroplasty of Carpometacarpal and/or Pantrapezial Osteoarthritis
Official title: Arthroscopic Resection Arthroplasty of Basal Joint Arthritis: Comparing Outcomes of Isolated Carpometacarpal to Pantrapezial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thumb Osteoarthritis
Lead sponsor: Orthopaedic Specialist, PC, Davenport, IA
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 125
Sex: ALL
Minimum age (years): 35
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with basal joint arthritis who were scheduled to undergo arthroscopic resection arthroplasty of the CMC and/or STT joints.

Brief summary: Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT

Detailed description: The purposes of this study were to report 1) long-term outcomes on a large series of patients that underwent arthroscopic resection arthroplasty (ARA) for thumb basal joint arthritis (BJA) and 2) to compare outcomes of ARA for isolated carpometacarpal osteoarthritis versus those undergoing simultaneous ARA of CMC plus the scaphotrapeziotrapezoid joint for pantrapezial disease.

Please note, all patients treated by Dr. Cobb for CMC and/or STT OA received the same treatment regardless of whether or not they chose to participate in the study. Patients who chose to enroll in the study received the same treatment as those who did not only their data was analyzed. Data collection is the same for those who do not participate, only their data is not analyzed.

Eligibility criteria: Inclusion Criteria:

* Primary cases of ARA for thumb BJA with isolated CMC ARA or simultaneous ARA of the CMC and STT joints.

Exclusion Criteria:

* Exclusions included 19 cases that received interposition materials that since have been shown to produce unfavorable postoperative inflammatory responses, (Orthadapt Bioimplant, Pegasus Biologics, Irvine, CA and Artimplant Artelon CMC-I Spacer, Small Bone Innovations, LLC, New York, NY), 6 cases that had prior CMC surgery, and 27 cases that underwent concomitant surgeries that would potentially effect outcome.

Primary outcomes:
measure: Strength (pinch and grip)
timeFrame: Change from baseline to 2 year follow-up.
Secondary outcomes:
measure: Satisfaction with Perceived Surgical Outcome
timeFrame: Reported at 2 year postoperative follow-up
measure: Pain
timeFrame: Change from baseline to 2 year follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04502615: Effect of Sand on Knee Load and Muscle Activity During a Single Leg Landing Task
Official title: Effect of Sand on Knee Load and sEMG Activity During a Single Leg Landing Task: Implications for ACL Prevention and Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Leg Hop Sand Surface
Single Leg Hop Grass Surface
Single Leg Hop Firm Surface
Keywords: Sand
knee valgus
knee abduction moment
electromyography
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, repeated measures crossover design.
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of different surfaces on the load experienced by the knee when landing from a single leg hop. A sand, pliable grass and firm (hard floor) surface will be compared when hopping from a 30 cm height. Each subject will complete 5 hops on each surface in a random order. The muscle activity in selected muscles of the lower limb will also be investigated to see how this differs in the landing leg, when landing on the different surfaces.

Detailed description: The aim of this study is twofold: 1) To investigate the effect of sand on landing kinematics and kinetics at the knee joint when performing a single leg jump landing task (dominant leg), comparing sand with a firm surface and pliable grass control. 2) To investigate the sEMG activity of the hamstring, quadriceps and gastrocnemius muscles of the dominant leg during the jump landing task on these different surfaces (from take off through to terminal knee flexion at the end of the landing phase).

Eligibility criteria: Inclusion Criteria:

* Female
* Participate in a minimum of 3 hours sporting activity per week.
* Provided Informed Consent
* Must be over 16 years of age (16-45 years)
* No exclusion criteria

Exclusion Criteria:

* Not willing to provide informed consent
* Pregnant
* History of ACL injury or other knee pathology
* Significant lower limb pathology
* Previous lower limb fracture or surgery
* Lower Limb injury in last 3 months.
* Male

Primary outcomes:
measure: knee abduction moment (N.m)
timeFrame: 1 testing session (1 day)
measure: knee valgus
timeFrame: 1 testing session (1 day)
measure: surface electromyography (sEMG) activity pre and post landing
timeFrame: 1 testing session (1 day)
Secondary outcomes:
measure: Anterior tibial translation
timeFrame: 1 testing session(1 day)
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University
Study officials:
affiliation: Teesside University
name: Mark Richardson, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02335515: The Gastric Residence Time (GRT) of Soctec Capsule After a Standardized Breakfast
Official title: Gastric Retention Time of Floating Gastro-Retentive Capsules in Male Healthy Subjects After Breakfast as Measured by Magnetic Resonance Imaging (MRI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Gastroretentive System
Gastric Retention Time (GRT)
capsule
Soctec
Gastroenterology
Lead sponsor: SkyePharma AG
Sponsor class: INDUSTRY
Collaborators: name: University of Zurich
First posted: 2015-01-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study was to assess the gastric residence time (GRT) of the Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial screening visit. Eligible subjects will undergo the study procedure. The hypothesis is that the GRT of the Soctect Capsule after a standardized breakfast and lunch will be longer compared to literature values reported for a simliar sized capsule.


Eligibility criteria: Inclusion Criteria:

* Male HS, aged between 18 and 50 years.
* Subjects must be in a good health and have BMI between 19 and 25 kg/m2.
* Subjects must be able to read, understand and sign the written informed consent.
* Subjects must be willing and able to comply with study requirements.

Exclusion Criteria:

* History of gastrointestinal, cardiorespiratory (including arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or alcohol abuse.
* Subjects with a history of HIV, hepatitis B or hepatitis C.
* Requiring medication that might alter gut function, including anticholinergics, calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump inhibitors and non-steroidal anti-inflammatory drugs.
* Prior abdominal surgery other than uncomplicated appendectomy or hernia repair.
* Subject with claustrophobia (fear of small spaces).
* Presence of implants, devices or metallic foreign bodies that might interact with the MRI
* Participation in another investigational study where the study drug was received within 90 days prior to the screening visit.

Primary outcomes:
measure: To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast.
timeFrame: MRI scnas will be performed every 30 minutes starting after capsule intake for up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SkyePharma AG
name: Karim Bagate, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03469115: New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin
Official title: New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents aged 13-17 will be divided into two groups according to BMI (body mass index)
Primary purpose: SCREENING

Brief summary: The purpose of this study is to find out if there is a connection between a higher level of peptide alpha defensin in blood serum with the metabolic profile of adolescents aged 13-17.


Eligibility criteria: Inclusion Criteria:

* Youths with metabolic syndrome (BMI above 95%)
* Youths with BMI below 3%

Exclusion Criteria:

-

Primary outcomes:
measure: Alpha defensin level
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Eias Kassem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01649115: The Healthy Lifestyles Passport Program: a Nutrition Education Program to Prevent Childhood Obesity
Official title: The Healthy Lifestyles Passport Program: a Randomized Control Trial of a Prenatal Maternal Education Program to Prevent Infant and Childhood Obesity (HLPP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Keywords: obesity
overweight
childhood obesity
prevention
Z score
weight for length
WFL
body mass index
BMI
prenatal
maternal
nutrition education
health education
health literacy
health numeracy
passport
healthy lifestyles
growth
growth chart
Lead sponsor: Bronx-Lebanon Hospital Center Health Care System
Sponsor class: OTHER
Collaborators: name: UnitedHealthcare Foundation
First posted: 2012-07-25
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of the Healthy Lifestyles Passport Program (HLPP) in preventing infant and childhood obesity. It is hypothesized that the participants in the intervention arm will exhibit less excessive weight-for-length gain from 4- to 6-months of age. In 2-years and 5-years, it is predicted that the participants in the intervention arm will yield lower Body Mass Index (BMI) z-scores than the participants in the control arm, who receive usual care.


Eligibility criteria: Inclusion Criteria:

* pregnant women during the third trimester (\>28 weeks gestation) receiving care in the institution's Women's Health Center
* no medical conditions complicating their pregnancy
* must be able to communicate in English or Spanish
* be reachable by phone
* plan to be the consistent caretaker of the child at least 75% of the time
* plan to attend the institution's pediatric outpatient clinic for the child's routine healthcare

Exclusion Criteria:

* Child with any disabling or chronic illnesses
* Any existing and/or pre-existing disabling or chronic illnesses that would qualify the mother as "high risk"
* Wards of the state
* Mothers with a disabling/serious chronic illness
* Drug/alcohol use during pregnancy

Primary outcomes:
measure: Change in child's gender-specific weight-for-length (WFL) z-score
timeFrame: 4-months to 6-months of the child's age
Secondary outcomes:
measure: Child's Body Mass Index (BMI)
timeFrame: At 2-years and 5-years of the child's age.
measure: Mother's Knowledge, Skill, Attitude and Behavior.
timeFrame: Baseline, day after the intervention and two months after the baby is born.
Other outcomes:
measure: Change in child's gender-specific weight-for-length (WFL) z-score
timeFrame: 0-months to 2-months of the child's age
measure: Change in child's gender-specific weight-for-length (WFL) z-score
timeFrame: 2-months to 4-months of the child's age
Locations:
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center
state: New York
Study officials:
affiliation: Bronx-Lebanon Hospital Center
name: Mamta Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238315: Safety and Efficacy Study of HuCNS-SC in Subjects With Neuronal Ceroid Lipofuscinosis
Official title: A Phase Ib Study of the Safety and Preliminary Efficacy of Allogeneic Intracerebral Human Central Nervous System Stem Cell Transplantation in Subjects With Non-Refractory Infantile and Late Infantile Neuronal Ceroid Lipofuscinosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Neuronal Ceroid Lipofuscinosis
Keywords: Batten's disease
INCL
LINCL
Neuronal Ceroid Lipofuscinosis
NCL
Lead sponsor: StemCells, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase Ib study is to determine if "Human Central Nervous System Stem Cells"(HuCNS-SC) is safe to be transplanted in subjects with infantile and late infantile neuronal ceroid lipofuscinosis. The study will also measure post-transplantation disease progression.

Detailed description: Participation in this study will involve screening assessments, surgery to implant HuCNS-SC, medication to suppress immune system and a series of follow-up assessments.

Eligibility criteria: Inclusion Criteria:

* Age 6 months to 6 years
* Male or female
* Clinical diagnosis of Infantile neuronal ceroid lipofuscinosis or late infantile neuronal ceroid lipofuscinosis
* CLN1 or CLN2 mutation

Exclusion Criteria:

* Previously received an organ, tissue or bone marrow transplantation
* Previously participated in any gene or cell therapy study
* Infection with hepatitis virus, cytomegalovirus, Epstein-Barr virus, or Human Immunodeficiency Virus (HIV)
* Current or prior cancer
* Bleeding disorder
* Unable to have an MRI scan

Primary outcomes:
measure: number of participants with adverse events.
timeFrame: one year following transplantation
Secondary outcomes:
measure: Number of subjects with improvement in neurological, neuropsychological development, MRI and MRS
timeFrame: one year following transplantation
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Nathan Selden, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01205815: Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with melanoma.

Brief summary: The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.


Eligibility criteria: Inclusion criteria

* Pathologically-proven diagnosis of melanoma.
* Patient must have a test or procedure that has the potential to provide left-over tissue that can be banked for future research purposes OR the patient has already had a diagnostic or therapeutic procedure but who has not yet been approached to participate is also eligible.

Exclusion criteria

* Any patient with significant contraindications to venipuncture (e.g., severe anemia) will be excluded from blood collection procedures. However, if the patient provides consent and a paraffin-embedded block or 10-15 unstained slides of their tissue diagnosis, they will not be excluded from this protocol.
* Any patient unable or unwilling to provide consent.

Primary outcomes:
measure: Molecular changes in patients' melanoma tissue
timeFrame: at 120 months
Secondary outcomes:
measure: Improve the time between ordering the test and results entry into medical records
timeFrame: 120 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbitl-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Douglas Johnson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yan C, Saleh N, Yang J, Nebhan CA, Vilgelm AE, Reddy EP, Roland JT, Johnson DB, Chen SC, Shattuck-Brandt RL, Ayers GD, Richmond A. Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade. Mol Cancer. 2021 Jun 6;20(1):85. doi: 10.1186/s12943-021-01366-y.
Clinical trial NCT06394115: Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
Official title: Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colostomy Stoma
Ileostomy - Stoma
Keywords: Ileostomy
Colostomy
Quality of Life
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
Collaborators: name: Princeton Consumer Research
First posted: 2024-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 15 colostomy and minimum of 10 ileostomies

Brief summary: The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.


Eligibility criteria: Inclusion Criteria:

* • Subjects with a colostomy or ileostomy

  * Age 18 years and over
  * Medically stable in the opinion of the investigator
  * Are able and willing to provide informed consent
  * Are able and willing to attend study visits
  * Currently use the same models of pouches as required by the study
  * Have a recent history of frequent pancaking (colostomy patients only)
  * Willing to stop using any lubricants in the pouches whilst participating in the study.
  * Subject has a valid email address for the Investigator to send links to study questionnaires and has access to a web enabled device.

Exclusion Criteria:

* • Subjects with any peristomal skin condition classified as non-intact skin at the time of enrolment

  * Subjects who maybe receiving any concomitant treatment and/or medications which could impact the consistency of effluent during the study period.
  * Allergic to any components of the Novel Lubricant inclusive of Soyabean and/or Vitamin E.

Primary outcomes:
measure: Performance of Convatec ostomy pouches which have the novel coating
timeFrame: 16 days
Secondary outcomes:
measure: to investigate the safety of Convatec Ostomy Pouches modified with a novel coating
timeFrame: 16 days
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Princeton Consumer Research
state: Florida
city: Raritan
country: United States
facility: Princeton Consumer Research
state: New Jersey
Study officials:
References:
Clinical trial NCT01283815: Laparoscopic Management of Periappendicular Abscess
Official title: Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Appendicitis
Abdominal Abscess
Keywords: Laparoscopy
Drainage
Appendectomy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not possible because of anatomical position of the abscess and surgical treatment is needed. The purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the first-line treatment in patients with periappendicular abscess.

The hypothesis of the study is that laparoscopic management of periappendicular abscess is suitable for the first-line treatment and it does not increase time of hospitalization or complication rate compared with conservative management.


Eligibility criteria: Inclusion Criteria:

* Periappendicular abscess at least 2 cm in size

Exclusion Criteria:

* Missing written informed consent
* Antimicrobial therapy lasted over 24 hours before randomization
* Attempt of drainage before randomization
* Age over 80 years or under 18 years old
* Pregnancy
* Allergy to either Cefuroxime or Metronidazole
* Severe chronic disease, that substantially increases the risk for operative mortality
* Previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions
* Carrier of a resistant bacterial strain
* Being institutionalized or hospitalized for at least 2 weeks before randomization

Primary outcomes:
measure: Time of hospitalization within the first 60 days after randomization
timeFrame: Day 60 after randomization
Secondary outcomes:
measure: Need of additional interventions
timeFrame: Within the first 60 days after randomization
measure: Residual abscess
timeFrame: On day 7 after randomization
measure: Attempted procedure not successfully performed
timeFrame: During the first 24 hours after randomization
measure: The number of complications
timeFrame: Within 60 days from randomization
measure: Number recurrent abscesses
timeFrame: Within 60 days after randomization
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Meilahti Hospital
Study officials:
affiliation: Department of Gastrointestinal Surgery, Helsinki University Central Hospital
name: Panu Mentula, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: