louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05012488: Comparison of the Effects of Morton's Neuroma on Foot Pressure Distribution and Gait Parameters in Pes Planus and Pes Cavus Patients
Official title: Comparison of the Effects of Morton's Neuroma on Foot Pressure Distribution and Gait Parameters in Pes Planus and Pes Cavus Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morton Neuroma
Pes Planus
Pes Cavus
Keywords: gait
foot pressure
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteer patients older than 18 years of age with bilateral pes planus or pes cavus accompanied by Morton's neuroma will be recruited by simple randomization.

Brief summary: The aim of our study is to compare the effect of Morton's neuroma in feet with pes planus and pes cavus on foot pressure and temporal and spatial gait parameters.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with bilateral pes planus or pes cavus
* Diagnosis of unilateral Morton neuroma
* Confirmation of the diagnosis of Morton's neuroma with Magnetic Resonance Imaging (MRI)
* Pain level of the patients during walking is at least 3 according to the Visual Analogue Scale (VAS).

  * Volunteer to study over the age of 18

Exclusion Criteria:

* Having Symptomatic musculoskeletal disease in the lower extremity
* Having peripheral nervous system disease
* Presence of rigid deformity in the foot
* Extremity or contralateral extremity surgery with Morton's neuroma
* Having received physiotherapy in the last 3 months

Primary outcomes:
measure: Foot rotation
timeFrame: 4 weeks
measure: Step length
timeFrame: 4 weeks
measure: Stance phase percentage
timeFrame: 4 weeks
measure: Swing phase percentage
timeFrame: 4 weeks
measure: Cadance
timeFrame: 4weeks
measure: Velocity
timeFrame: 4 weeks
measure: Foot pressure distiribution
timeFrame: 4 weeks
Secondary outcomes:
measure: Demographic data/patient age
timeFrame: 4 weeks
measure: Demographic data/patient weight
timeFrame: 4 weeks
measure: Demographic data/patient height
timeFrame: 4 weeks
measure: Demographic data/patient body mass index BMI
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fulya Foot Surgery Center
Study officials:
References:
Clinical trial NCT00735488: Sickle Cell Anemia Screening and Prevention in Northern Israel
Official title: Summary of the Data From the Prevention Programme for Hemoglobinopathies in Northern Israel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Sickle Cell Anemia
Keywords: Thalassemia
Sickle cell anemia
Carrier detection
Prenatal Diagnosis
Genetic counseling
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Israel
First posted: 2008-08-15
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The program for prevention of hemoglobinopathies in Northern Israel, instituted since 1987, covered the northern part of Israel, including the Jezreel valley, the Nazareth area, the upper Galilee, the Hula valley and the northern part of the seashore region7. The overall population in this region is about a million inhabitants with about 50 % of Arab population, and a significant percentage of them from Bedouin origin, a population that at least partially is of African origin.

Brief summary: Since 1987, a screening for β Thalassemia in pregnant women is carried on in northern Israel, and from 1999 all the samples were tested also for Hgb S, Hgb C, Hgb D, Hgb O Arab and others.

In this study, the investigators intend to summarize the results of this preventive program aiming to detect couples at risk for having offspring with Thalassemia or SCA, the compliance regard to genetic counseling and prenatal diagnosis and the incidence of new affected babies born.


Eligibility criteria: Inclusion Criteria: All pregnant women tested and their husband in those cases that the woman test revealed abnormal hemoglobin.

Exclusion Criteria: No exclusion criteria.

Primary outcomes:
measure: Number of carriers detected
timeFrame: End of study
Secondary outcomes:
measure: Couples referred for prenatal diagnosis
timeFrame: End of study
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - Ha'Emek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
name: Ariel Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05715788: Prone Positioning vs. Prone Positioning and NO Inhalation in COVID-19 ARDS.
Official title: Prone Positioning Versus Prone Positioning and NO Inhalation in COVID-19 Associated Acute Respiratory Distress Syndrome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-02-08
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: NON_PROBABILITY_SAMPLE
Study population: Patients with COVID-19 associated ARDS

Brief summary: The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS.

Detailed description: The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS. Patients with COVID-19-associated ARDS were ventilated in prone position with or without NO inhalation, the arterial blood gas (ABG) tests were performed at 16 hours after prone positioning.

Eligibility criteria: Inclusion Criteria:

* Adult patients with COVID-19 associated ARDS

Exclusion Criteria:

* patients who have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure

Primary outcomes:
measure: P/F ratio
timeFrame: 16 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ming Zhong, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05107388: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer
Official title: AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Diabetes
Keywords: Breast Cancer, Alpelisib, hyperglycemia
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days

Detailed description: AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.

Eligibility criteria: Inclusion Criteria:

1. Women suffering breast cancer and eligible to treatment with Alpelisib
2. Age ≥18 years
3. Menopausal women (for at least 24 months)
4. Informed Consent Form signed

Exclusion Criteria:

1. Men
2. Pregnant ou child-bearing potential women

Primary outcomes:
measure: Incidence rate of hyperglycemia
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Sophie BOROT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05021588: Steroid and Anticoagulant Therapy in covid19
Official title: Challenges in Steroid and Anticoagulant Therapy in Severe COVID-19 Pneumonia: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Viral
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As COVID-19 has neither standard treatment protocol nor guidelines, there are many treatment protocols foranti-inflammatory corticosteroids and anti-coagulations for severe COVID-19 pneumonia patients. This study aimed to assess the most suitable modality in this high-risk group.

Methods: A prospective, experimental study design was adopted, that included 123 severe COVID-19 pneumonia patientsadmitted at Assiut UniversityHospital from April 10th, 2020, to September10th, 2020. Patients were divided into 3 groups according to a combined corticosteroid and anticoagulants therapy protocols. Group A included 32 patients, group B included 45 patients, and group C included 46 patients. Assessment of cases was conducted according to the treatment type and duration, weaning duration from oxygen therapy, length of hospital and ICU stay, and complications during treatment.Three months follow up after discharge was performed.


Eligibility criteria: Inclusion Criteria:

* respiratory distress \[respiratory rate (RR) \>30 breaths/min at rest\], mean oxygen saturation ≤93%,ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤300 mmHg,\>50% lung involvement on imaging within 24 to 48 hours of admission

Exclusion Criteria:

* pnumonia not caused by covid19

Primary outcomes:
measure: Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Marwarady
Study officials:
References:
Clinical trial NCT03078088: Airway Alkalinization and Nasal Colonization
Official title: Airway Alkalinization and Nasal Colonization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Cystic Fibrosis
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study will be a randomized, cross-over study of THAM followed by saline or saline followed by THAM in human non-CF and CF subjects to assess nasal colonization

Detailed description: 16 subjects per group will be randomized to receive study drug or saline followed by a wash out period and cross-over to the other treatment, three times daily for 4 days. Nasal swab will be done at baseline and after both study treatment and saline treatment for assessment of airway colonization.

Eligibility criteria: Healthy subjects:

Inclusion Criteria:

* 16 subjects, aged 16-80, clinically stable with no significant changes in health status for 14 days prior to Day 1, written informed consent obtained fom subject.

Exclusion Criteria:

* Pregnant or lactating
* Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to screening, smoked in the last 6 months.

CF subjects:

Inclusion Criteria:

* FEV1% \>35%, O2 saturation \>90% on room air, clinically stable with no significant changes in health status for 14 days prior to Day 1, written informed consent obtained from subject.

Exclusion Criteria:

* Same as for healthy subjects.

Primary outcomes:
measure: Nasal bacterial colonization
timeFrame: Day 5 of placebo or Tham intervention
Secondary outcomes:
measure: Safety assessment questionnaire
timeFrame: Day 5 of placebo or Tham intervention
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Univeristy of IOwa
state: Iowa
Study officials:
References:
Clinical trial NCT05178888: Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)
Official title: A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.

Detailed description: This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
* Unresectable or metastatic disease.
* No available treatment with curative intent
* Adequate organ function

Exclusion Criteria:

* History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow
* Other active cancer
* Cardiac abnormalities

Primary outcomes:
measure: Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation.
timeFrame: 24 months
measure: Evaluate Pharmacokinetics of the combination regimen
timeFrame: 24 months
measure: Establish Maximum Tolerated Dose
timeFrame: 24 months
measure: Evaluate preliminary clinical activity of the combination regimen
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Local Institution - 804
state: Florida
city: Nashville
country: United States
facility: Local Institution - 803
state: Tennessee
city: Houston
country: United States
facility: Local Institution - 802
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 801
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05811988: Cost Assessment of Videolaryngoscopy Compared to Direct Laryncoscopy in a Large Academic Center
Official title: Cost Assessment of Videolaryngoscopy Compared to Direct Laryncoscopy in a Large Academic Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Economic Problems
Lead sponsor: Adam Thaler
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-04-13
Enrollment: 66987
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults

Brief summary: Cost, both direct and indirect, assessment of videolaryngoscopy, specifically the McGrath, compared to direct laryncoscopy in a large academic center.


Eligibility criteria: Data were obtained on all endotracheal intubations where the Anesthesiology service was assigned to staff a surgical case requiring tracheal intubation during general anesthesia. Data were also obtained for tracheal intubations outside the operating room (ICUs, Trauma, patient wards) when Anesthesiology personnel were requested which did not include the Emergency Department

Electronic patients' medical records spanning a two-year period (July 1, 2019 to June 30, 2021)

Primary outcomes:
measure: Cost comparison
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00758888: Effect of Orthopedic Blocking on Cervical Spine Flexion and Extension Strength
Official title: Effect of Orthopedic Blocking on Cervical Spine Flexion and Extension Strength
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sacroiliac Function
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A few studies concerning the effects of joint manipulation have shown muscle responses distal to the site of manipulation. The purpose of this study is to determine if pelvic orthopedic blocking, a low force method of manipulating the sacroiliac joint, can have produce changes to cervical spine function.

Detailed description: All mechanoreceptor types are found in diarthrodial joints. Mechanoreceptor afferents have reflexive connections to motor neurons. Stimulation of muscle and joint afferents are known to produce reflexive muscle changes. Orthopedic blocking applies a gentle compression to the sacroiliac joints. The current study seeks to determine if orthopedic blocking of the sacroiliac joint can affect cervical spine function thereby serving as a useful adjunctive procedure in the treatment of cervical spine joint dysfunction. The current study will compare pre \& post treatment cervical isometric strength readings from an orthopedic blocking group, a trochanter belt group (another type of compression), and a sham group.

Eligibility criteria: Inclusion Criteria:

* Logan faculty, students, or staff 18-30 years of age with a leg-length inequality of 5mm or more.

Exclusion Criteria:

* Fractures
* Tumors
* Myopathies
* Consumption of prescription drugs that affect nervous system function
* Recent cervical spine injuries or surgeries
* Cervical pain

Primary outcomes:
measure: Cervical Isometric Strength
timeFrame: Pre and post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT04592588: Evaluating an Online Wellness Intervention for Indian College Students
Official title: Online Wellness Activities for Indian College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Happiness
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Ashoka University
name: Jindal Global University
First posted: 2020-10-19
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with Indian college students. Students will be randomized to the COMET condition or to a wait-list control condition.

Primary outcome measures (depressive symptoms, anxiety symptoms, and subjective well-being) will be measures at two weeks post-intervention, four weeks post-intervention, and twelve weeks post-intervention.

We will evaluate COMET as a universal intervention (using the full sample) and as a targeted intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms at baseline).


Eligibility criteria: Inclusion Criteria: At least 18 years old and a student at a participating university in India.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Up to 12 weeks post-intervention
measure: Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
timeFrame: Up to 12 weeks post-intervention
measure: Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
timeFrame: Up to 12 weeks post-intervention
Secondary outcomes:
measure: Ratings on the Acceptability of Intervention Measure (AIM)
timeFrame: Immediately after the intervention
measure: Ratings on the Intervention Appropriateness Measure (IAM)
timeFrame: Immediately after the intervention
measure: Mechanisms of Change
timeFrame: Up to 12 weeks post-intervention
measure: Ability to Cope with COVID-19
timeFrame: Up to 12 weeks post-intervention
measure: Secondary Control
timeFrame: Up to 12 weeks post-intervention
measure: Perceived Utility
timeFrame: Immediately after the intervention
measure: Positive and Negative Affect Schedule
timeFrame: Up to 12 weeks post-intervention
measure: Perceived Stress Scale-4
timeFrame: Up to 12 weeks post-intervention
measure: The Social Connectedness Scale
timeFrame: Up to 12 weeks post-intervention
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Ashoka University
city: Sonipat
country: India
facility: Jindal Global University
Study officials:
References: