louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01440205: Licensing Flu Shot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flu
Keywords: Flu Shot
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 6098
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The mailer will encourage all employees of one of Evive's partner companies to attend an on-site free flu shot clinic they are offering in the fall of 2011. The research will examine differences in follow-through on getting a flu shot at an on-site clinic among the targeted population during the \~1 month period when clinics are being offered (following the mailing) as a function of experimental condition.


Eligibility criteria: Inclusion Criteria:

* Employee at partner corporation

Exclusion Criteria:

* Employee already received a flu shot this season

Primary outcomes:
measure: Number of Participants that receive a flu shot
timeFrame: up to two months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine L Milkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06564805: Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata
Official title: Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alopecia Areata
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of two intralesional treatment modalities for alopecia areata will be determined. Thirty patients over the age of 6 with the diagnosis of alopecia areata on the scalp, with an extension of less than 50%, will be included. A comparison will be made between the effectiveness of intralesional Triamcinolone (standard first-line treatment) and intralesional Candida albicans antigen, with serial clinical and trichoscopic pictures at follow-up to evaluate the clinical response and associated adverse effects.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of alopecia areata
* SALT score of less than 50% extension
* Has not received any topical or systemic treatment in the last month
* Signed informed consent

Exclusion Criteria:

* Any skin condition on the scalp (infectious, inflammatory or neoplastic) that could modify the clinical of trichoscopic features
* Pregnancy or breast-feeding
* Patients in medications that could cause hair loss as side-effects

Primary outcomes:
measure: Treatment response
timeFrame: 5 months
Secondary outcomes:
measure: Side effects
timeFrame: 5 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. José Eleuterio González"
state: Nuevo León
Study officials:
affiliation: Hospital Universitario "Dr. José E. González"
name: Fania Muñoz Garza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03218605: Which Physical Activity Influences Achilles Tendon Blood Flow the Most?
Official title: Effect of Warming-up Activities on the Vascularisation of the Achilles Tendon: a Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Achilles tendon
Warming-up
Vascularisation
Physical activity
Oxygen-to-See (O2C)
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as to the most solid warming-up of the AT. Therefore, knowledge about activities which increase blood flow in the AT could be useful in the development of a solid warming-up programme for the AT. The aim of this investigation was to define the influence of different kinds of physical activity on the vascularisation of the AT in a healthy asymptomatic population. Subjects performed five activities in randomized order: running, static stretch, dynamic stretch, cycling and rope skipping. The vascularisation of the AT of the dominant limb was measured with the non-invasive oxygen-to-see (O2C) device. Blood flow was measured before, immediately after, five and ten minutes after activity to investigate the duration of the vascular response to activity.


Eligibility criteria: Inclusion Criteria:

* no history of Achilles tendon complaints
* healthy and active adolescents

Exclusion Criteria:

* history of Achilles tendon pain or current complaints
* not healthy or not active population
* children

Primary outcomes:
measure: Change in Achilles tendon blood flow
timeFrame: 3 minutes before and immediately (0 minutes) after the physical activity to assess the change in blood flow due to the physical activity
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
References:
citation: Wezenbeek E, De Clercq D, Mahieu N, Willems T, Witvrouw E. Activity-Induced Increase in Achilles Tendon Blood Flow Is Age and Sex Dependent. Am J Sports Med. 2018 Sep;46(11):2678-2686. doi: 10.1177/0363546518786259. Epub 2018 Aug 1.
Clinical trial NCT00042705: Asthma Severity in Children and Environmental Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
indoor allergens
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-08-06
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This study measures residential exposures (indoor allergens, mold, nitrogen dioxide, nicotine) and relates exposure levels to daily symptoms (wheeze, persistent cough, chest tightness, shortness of breath) and medication use, in a population of children with physician diagnosed asthma, followed for 12 months.


Eligibility criteria: * Siblings of a birth cohort recruited 1997-1999
* Age less than 11 years
* Physician diagnosed asthma
* Active symptoms (wheeze, persistent cough, chest tightness, shortness of breath) or medication use in the 12 months prior to enrollment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New haven
country: United States
facility: Yale Center for Perinatal, Pediatric & Environmental Epidemiology
state: Connecticut
Study officials:
References:
Clinical trial NCT00687505: Safety Study of FP-1039 To Treat Cancer
Official title: A Phase 1, Open-Label, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of FP-1039 in Subjects With Metastatic or Locally Advanced Unresectable Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Five Prime Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2008-05-30
Enrollment: 39
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: The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer.


Eligibility criteria: Inclusion Criteria:

* Subjects with metastatic or locally advanced unresectable solid tumors for which standard curative or supportive measures do not exist or are no longer effective
* Male or female 18 years of age or older

Exclusion Criteria:

* Presence or history of melanoma
* Primary brain tumor
* Presence or history of glaucoma

Primary outcomes:
measure: Safety and tolerability
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: San Antonio
country: United States
facility: START (South Texas Accelerated Research Therapeutics)
state: Texas
Study officials:
References:
Clinical trial NCT05892705: Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.
Official title: Can Subarachnoid Dexmedetomidine Decrease the Incidence of Postoperative Nausea and Vomiting and Shivering With Minimal Hemodynamic Instability in CS?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrathecal Dexmedetomidine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block.

Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not.

Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.

Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV


Eligibility criteria: Inclusion Criteria:

* Medically free pregnant Female from 18 to 30 yrs old.
* Undergoing elective LSCS.
* Body mass index less than 40.
* Consenting for sub arachnoid anesthesia.
* Coagulation profile is within normal ranges.

Exclusion Criteria:

* Emergency LSCS.
* Patient refusal enrollment in the study.
* Allergy to the medications.
* Coagulopathy or anticoagulation drugs.
* Fetal or Maternal comorbidities.

Primary outcomes:
measure: Effect of subarachnoid dexmedetomidine on hemodynamic parameters.
timeFrame: Two hours
Secondary outcomes:
measure: Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.
timeFrame: Six hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasia
Study officials:
References:
Clinical trial NCT00887705: ADL- Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Activities of Daily Living (ADL)-Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Pulmonary Rehabilitation
ADL-Training
COPD Rehabilitation
Lead sponsor: LHL Helse
Sponsor class: OTHER
First posted: 2009-04-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: ADL training of copd patients results in better execution of activities of daily living.


Eligibility criteria: Inclusion Criteria:

* COPD
* Referred for rehabilitation
* Age \> 18 years
* Symptoms affecting ADL function
* 6 minute walk distance (6MWD) \< 400 meters

Exclusion Criteria:

* Patients who smokes or has smoked during the last three months.
* LTOT
* Patients who has another disability
* Patients who can't read or speak Norwegian

Primary outcomes:
measure: Canadian Occupational Performance Measure(COPM) - Self-perception of occupational performance and satisfaction.
timeFrame: Baseline, 4 weeks; 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: Glittreklinikken
state: Akershus
city: Hakadal
country: Norway
facility: Glittreklinikken
Study officials:
affiliation: LHL Helse
name: Morten S Ryg, Dr philos
role: STUDY_DIRECTOR
References:
Clinical trial NCT01359605: Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
Official title: An Open-Label, Single-Dose, Study to Assess the Metabolism and Elimination of Varespladib After Oral Administration of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ADME
Healthy volunteers
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to characterize the metabolism and excretion (ADME) of a single oral dose of \[14C\]varespladib methyl.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedure
* Healthy males, 19 to 55 years of age
* Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, or vital signs at baseline in the opinion of the investigator

Primary outcomes:
measure: Changes in the varespladib blood levels and radioactivity in blood, urine and fecal samples
timeFrame: 1 hour prior to drug, and post dose: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, and 120 hours after drug
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
References:
Clinical trial NCT03130205: Biomarker Study in Pancreatic Neuroendocrine Tumours
Official title: Prospective Longitudinal Biomarker Study in Pancreatic Neuroendocrine Tumours
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroendocrine Tumors
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-resectable metastatic pancreatic neuroendocrine tumors at the Department of Endocrine Oncology, Uppsala, Sweden.

Brief summary: The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Informed consent
* WHO performance status ≤2
* Progressive disease (as defined by the local investigator) or newly diagnosed disease (defined as prior to medical or oncological intervention except for somatostatin analogue treatment).
* Pathology confirmed diagnosis of pancreatic or duodenal neuroendocrine tumour WHO G1-G3.

  o Exception: In newly diagnosed patients with high suspicion of PNET based on clinical and radiological parameters where tissue sample have not yet been obtained. These patients may be included and subsequently excluded if pathology cannot confirm NET.
* Biopsy procedure not associated with inappropriate risk as determined by the responsible physician.

Exclusion Criteria:

* Patient does not consent
* Permanent risk factors for biopsy

  * Long term treatment with anticoagulant that cannot be temporarily paused without unacceptable risk.
  * Permanent coagulation disorder
* Pregnancy or no contraceptive in fertile women.

Primary outcomes:
measure: Correlation between FDG-PET and tumor biology
timeFrame: Through study completion, an average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
Study officials:
affiliation: Akademiska Sjukhuset, Uppsala
name: Barbro Eriksson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06042205: TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
Official title: ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Atraumatic Hernia Repair System (TAHRS) for Laparoscopic Hernia Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hernia
Lead sponsor: Tissium
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS


Eligibility criteria: Key Inclusion Criteria:

1. Subject is 18 years old or older;
2. Patient willing and able to provide a signed Patient Informed Consent Form;
3. Has a midline primary ventral, umbilical or incisional hernia;
4. Scheduled for a laparoscopic IPOM hernia repair;
5. Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect

Key Exclusion Criteria:

1. Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
2. BMI \> 40;
3. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
4. Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
5. Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
6. Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
7. Patient has more than one hernia defect (to be confirmed intraoperatively);

Primary outcomes:
measure: Serious Adverse Device Effect (SADEs)
timeFrame: through 12 months post-surgery
Secondary outcomes:
measure: Rate of hernia recurrence through 12 months post- surgery
timeFrame: through 12 months post-surgery
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg [ZOL]
state: Limburg
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Ruddershove
country: Belgium
facility: AZ Sint-Jan
city: Yvoir
country: Belgium
facility: CHU UCL Namur
city: Seville
country: Spain
facility: Universitary Hospital Virgen Macarena
Study officials:
References:
Clinical trial NCT00805805: Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis
Official title: Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Biliary Cirrhosis
Keywords: Copper
ceruloplasmin
tetrathiomolybdate
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: FDA Office of Orphan Products Development
First posted: 2008-12-10
Enrollment: 29
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: The University of Michigan is conducting a study investigating a potential new treatment aimed at slowing/halting progression of primary biliary cirrhosis. This will be a 2 arm double blind study in which half of the patients will be randomly selected to receive a placebo (capsule with no active ingredient) and half will receive the new treatment drug, tetrathiomolybdate. Neither the patient nor the treating physician will know which arm the patient is in. The length of the study for each patient is 24 months of drug therapy. Lab draws will be necessary weekly for the first 6 weeks of the study, followed by every other week for 3 weeks, and then monthly for the remainder of the 2 year period. In addition, intermittent history and physicals and urine samples will also be necessary. There is no cost to you for any experimental treatment. All patients in both arms will continue on ursodiol and receive standard of care treatment


Eligibility criteria: Inclusion Criteria:

* Generally medically healthy
* Age 18 and older
* Documented primary biliary cirrhosis
* Alkaline phosphatase \> 137

Exclusion Criteria:

* Severe liver decompensation
* Requirement for renal dialysis
* Pregnancy or nursing
* Meld score \> 15 (13-15 will require a physician's clinical judgment)
* Uncontrolled congestive heart failure
* Severe diabetic neuropathy
* Severe pulmonary disease
* Advanced cancer
* Requirement for steroid therapy
* Uncontrolled ascites, variceal hemorrhage or spontaneous bacterial peritonitis
* Pregnant or nursing

Primary outcomes:
measure: Improvement in drug treated group vs placebo group in two liver function tests and one serum cytokine measurement
timeFrame: 2 years
Secondary outcomes:
measure: Improvement in drug treated group vs placebo group in serum CRP or interleukin-1-beta-levels
timeFrame: 2 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: