louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03471429: Canine-assisted ANxiety Reduction IN Emergency
Official title: Canine-assisted ANxiety Reduction IN Emergency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: Anxiety
Dog
Canine
Therapy
Depression
Pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled from Emergency Department that are 18 or older with moderate or greater anxiety, per physician Gestalt.

Brief summary: The purpose of this study is to see if dogs can reduce the anxiety level of patients in the emergency department.

Detailed description: Patients will score their pain, anxiety, and depression. A dog will then come into the patient's room for approximately 15 minutes after which the patient will score his/her pain, anxiety, and depression again.

Eligibility criteria: Inclusion Criteria:

* Research staff will screen for inclusion criterion by asking the care providers if they agree with this statement, "I believe this patient is experiencing moderate or greater anxiety".

Exclusion Criteria:

* Extreme intoxication, agitation that precludes conversation with the patient, fear of dogs, dog bite, allergy to dogs.

Primary outcomes:
measure: Anxiety reduction from Scale
timeFrame: 30 mins
Secondary outcomes:
measure: Pain reduction from Wong Baker faces scale
timeFrame: 30 mins
measure: Depression reduction from scale
timeFrame: 30 mins
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
citation: Kline JA, Fisher MA, Pettit KL, Linville CT, Beck AM. Controlled clinical trial of canine therapy versus usual care to reduce patient anxiety in the emergency department. PLoS One. 2019 Jan 9;14(1):e0209232. doi: 10.1371/journal.pone.0209232. eCollection 2019.
Clinical trial NCT00114829: Preoperative Assessment of Colon Tumor
Official title: Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Cancer
Colorectal Tumor
Keywords: Colorectal cancer
Colorectal tumor
Dynamic contrast uptake
MR colonography
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2005-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.


Eligibility criteria: Inclusion Criteria:

* Colorectal cancer
* Colorectal tumor

Exclusion Criteria:

* Active diverticulitis
* Pacemaker
* Metal in the body
* Claustrophobia

Primary outcomes:
measure: Sensitivity in determining malignant or benign diagnose
Secondary outcomes:
measure: Sensitivity/specificity of MR colonography
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Radiology Copenhagen University Hospital Herlev
Study officials:
affiliation: Department of Radiology Copenhagen University Hospital Herlev
name: Michael P Achiam, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Achiam MP, Andersen LP, Klein M, Logager V, Chabanova E, Thomsen HS, Rosenberg J. Differentiation between benign and malignant colon tumors using fast dynamic gadolinium-enhanced MR colonography; a feasibility study. Eur J Radiol. 2010 Jun;74(3):e45-50. doi: 10.1016/j.ejrad.2009.03.033. Epub 2009 May 5.
Clinical trial NCT04679129: Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC42 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first in human study of single and multiple ascending doses and food effect of ASC42.

This study consists of 8 cohorts and is divided as follows:

Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male and female subjects between 18 to 65 years of age.
* Subjects' weight ≥ 50 kg and BMI within the range of 19 - 29 kg/m2.
* Physical examination and vital signs are within normal range or slightly abnormal.

Key Exclusion Criteria:

* History or current liver disease, or liver injuries.
* A positive HBsAg, HCV Ab and/or HIV Ab.
* Platelet count \<150,000/mcL
* INR\> 1.2

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 21 days
Secondary outcomes:
measure: AUC of ASC42
timeFrame: On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
measure: Cmax of ASC42
timeFrame: On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
measure: t1/2 of ASC42
timeFrame: On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
measure: CL/F of ASC42
timeFrame: On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
measure: Vd/F of ASC42
timeFrame: On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
measure: Tmax of ASC42
timeFrame: On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
measure: C4
timeFrame: On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
measure: FGF19
timeFrame: On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON early Phase Services LLC
state: Texas
Study officials:
References:
Clinical trial NCT06383429: Relation Between Forward Head Posture and Incidence of Headache in Obese Adults
Official title: Relation Between Forward Head Posture and Incidence of Headache in Obese Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obese
Headache
Neck Pain
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese adulty with forward head posture

Brief summary: Cross sectional study to detect relation between forward head posture and headache. We will take information from the patient about:

* Detailed history of patient
* Forward head posture by using mobile application
* Headache disability index


Eligibility criteria: Inclusion Criteria:

* obese adult with forward head posture

Exclusion Criteria:

* any neurological condition , autoimmune diseases and cervical disc

Primary outcomes:
measure: forward head posture
timeFrame: one time
measure: BMI
timeFrame: one time
measure: headache disability index
timeFrame: one time
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Ababa physical therapy center
state: Beni- Suaf
Study officials:
References:
Clinical trial NCT03169829: Safety and Efficacy of Plant-based Diets in Hemodialysis Patients
Official title: Safety and Efficacy of Plant-based Diets in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Disease
Keywords: Hemodialysis
Renal Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this proof-of-concept controlled-feeding study is to evaluate the impact of plant-rich diets, with and without high-potassium fruits and vegetables, on phosphorus and potassium homeostasis in hemodialysis (HD) patients.


Eligibility criteria: Inclusion Criteria:

* Receiving thrice-weekly outpatient HD treatments for end-stage renal disease
* 3-month mean serum potassium and phosphorus concentrations of \>4.5 mEq/L and \>4.0 mg/dL, respectively
* No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6 months
* Deemed appropriate for the intervention by the patient's nephrologist, considering the patient's prognosis, cognition and pending treatments (e.g., kidney transplant)

Exclusion Criteria:

* Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors, diuretics, beta-blockers) in the last month
* Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery, short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic diarrhea)
* Anemic, defined as a serum hemoglobin concentration \<9.0 g/dL
* Inadequate dialysis efficacy, defined as a Kt/V of \<1.2
* Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to study diets (excludes dietary restrictions on high-potassium foods)
* Pregnant or planning to become pregnant during the study

Primary outcomes:
measure: Pre-dialysis serum potassium concentrations.
timeFrame: Day 1
measure: Pre-dialysis serum phosphorus concentrations.
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: David St Jules, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02102529: Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis
Official title: Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Endometriosis
Keywords: pain
quality of life
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012

Brief summary: Endometriosis is one of the most frequent benign diseases that can affect women in their reproductive age. In severe form, the colon or rectum may be involved. It has been shown that the surgical treatment improve typical symptoms like pain and dyspareunia. The investigators evaluated the functional results and quality of life after laparoscopic colonic resection for endometriosis

Detailed description: A clinical analysis of thirty women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012. Quality of life and pain was documented postoperatively. We conduct a telephone survey, which starts at May 2014.

Eligibility criteria: Inclusion Criteria:

* •Clinical diagnosis of endometriosis

Exclusion Criteria:

* Unwillingness to participate on the survey

Primary outcomes:
measure: visual analog scala for pain
timeFrame: one year after the operation
Secondary outcomes:
measure: dyspareunia
timeFrame: one year after the operation
measure: dysuria
timeFrame: one year after operation
measure: obstipation
timeFrame: one year after operation
measure: pain during defecation
timeFrame: one year after operation
measure: rectal bleeding
timeFrame: one year after operation
Other outcomes:
Locations:
city: Linz
country: Austria
facility: 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
state: Upper Austria
Study officials:
affiliation: Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
name: Andreas Shamiyeh, Univ-Prof.Dr
role: STUDY_CHAIR
References:
citation: Haas D, Chvatal R, Habelsberger A, Wurm P, Schimetta W, Oppelt P. Comparison of revised American Fertility Society and ENZIAN staging: a critical evaluation of classifications of endometriosis on the basis of our patient population. Fertil Steril. 2011 Apr;95(5):1574-8. doi: 10.1016/j.fertnstert.2011.01.135.
Clinical trial NCT05284929: Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
Official title: Increased Frequencies of Certain HLA Class II Alleles DRB1 and DQB1 in PV Patients Compared to Those in Healthy Donors Have Been Reported in Various Populations and Repeatedly Confirmed. Among the Russian Population, no Studies About the Association of PV and HLA Class II Genes Have Been Conducted. Thus, the Purpose of This Study Was to Investigate HLA Class II Alleles and Haplotypes in Russian Patients With Pemphigus Vulgaris.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pemphigus
Bullous Pemphigoid
Stevens-Johnson Syndrome
Toxic Epidermal Necrolyses
Lead sponsor: Sechenov University
Sponsor class: OTHER
Collaborators: name: Pirogov Russian National Research Medical University
First posted: 2022-03-17
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 patients with confirmed diagnosis of pemphigus will be enrolled in the study Age \>18 years Sex: both females and males

100 healthy controls

Brief summary: Pemphigus is a rare autoimmune life-threatening blistering condition affecting skin and mucous membranes. Pemphigus belongs to a family of polygenic disorders. Several different genes encoding molecules regulate pemphigus autoimmunity. Many trials focused on HLA investigation. Increased levels of certain HLA class II alleles frequencies in pemphigus have been reported in various populations. However, they were not investigated in the Russian population.

The aim of our study is to investigate HLA class II alleles and haplotypes in Russian patients with pemphigus.

Methods

Patients and controls

We are recruiting 120 patients with pemphigus. The diagnosis was based on clinical and histopathological findings and confirmed by immunofluorescent techniques (direct and indirect immunofluorescent tests). Before sampling, written consent was obtained from each subject. A single blood sample for HLA typing was obtained from all subjects. This study has been approved by the Ethics Committee of Sechenov University, Russia. Phenotypic and allelic frequencies were compared with healthy blood donors (n=100) registered in Sechenov University blood center.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age of patients \>18 years
* Confirmed diagnosis

Exclusion Criteria:

* No as pemphigus is a life-threatening condition

Primary outcomes:
measure: Estimation of HLA-DRB1 and HLA-DQB1 alleles frequencies in PV patients and controls
timeFrame: May 2017 - 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
References:
Clinical trial NCT06841029: Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum: Evaluation of Clinical Practices in Five Maternity Hospitals in Île-de-France
Official title: Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum: Evaluation of Clinical Practices in Five Maternity Hospitals in Île-de-France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an Intervention
Keywords: NVP, hyperemesis gravidarum, clinical practices, adequacy, recommendations,CNGOF
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of 117 healthcare professionals from five maternity hospitals in Île-de-France, of which 104 responses were usable. The participants included:

68 midwives (65.4%)

27 obstetrician-gynecologists (26%)

9 gynecology-obstetrics interns (8.6%)

The distribution across hospitals was as follows:

Center A: 45 respondents (21 midwives, 17 obstetrician-gynecologists, 7 interns)

Center B: 17 respondents (all midwives)

Center C: 15 respondents (12 midwives, 3 obstetrician-gynecologists)

Center D: 15 respondents (9 midwives, 4 obstetrician-gynecologists, 2 interns)

Center E: 12 respondents (9 midwives, 3 obstetrician-gynecologists)

Brief summary: This clinical trial aims to evaluate the adequacy of healthcare professionals' clinical practices regarding nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG) with the recommendations of the National College of French Obstetricians and Gynecologists (CNGOF). The study involves 117 participants and follows an observational, cross-sectional, multicenter study design conducted in five maternity hospitals in Île-de-France.


Eligibility criteria: Inclusion Criteria:

* Midwives, obstetrician-gynecologists, and gynecology-obstetrics interns working in the labor and delivery units, high-risk pregnancy units, and obstetric-gynecological emergency units of the five selected maternity hospitals.

Exclusion Criteria:

* Midwives or doctors in training (student midwives or medical externs)
* Midwives and obstetrician-gynecologists working in private practice

Primary outcomes:
measure: Percentage of healthcare professionals whose management of NVP and HG aligns with CNGOF recommendations.
timeFrame: data collection period: October 2023-March 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hospitalier de Saint-Denis
Study officials:
References:
Clinical trial NCT02547129: Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
Official title: A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prosthetic Joint Infection of the Knee
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.


Eligibility criteria: Inclusion Criteria

1. Male or female age 18 to 100 years of age.
2. Preoperative diagnosis of bacterial infection by culture which would include a preoperative aspiration and at least three intraoperative cultures. The preoperative aspiration would also be sent for a cell count with differential. All patients would have an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) drawn in the preoperative phase. Patients with a negative preoperative aspiration, but an actively draining wound or draining sinus tract, would be considered as infected. Intraoperative histopathology would also be obtained in all cases of infected total knee replacement at the time of the resection.
3. Intact extensor mechanism.
4. Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
5. Adequate bone stock for knee reconstruction
6. Medical fitness for staged knee reconstruction

Exclusion Criteria

1. Known Atypical infection (mycobacterial or fungal)
2. Extensor mechanism disruption
3. Inadequate soft tissue envelope requiring muscle flap or skin grafting
4. Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
5. Medical status precluding staged knee reconstruction
6. Requirement for hinged knee reconstruction at the time of reimplantation
7. Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.

Primary outcomes:
measure: Number of Subjects With Repeat Infections
timeFrame: 1 year post-operatively
measure: Change in Total Knee Replacement Functional Scores
timeFrame: baseline, 1 year post-operatively
Secondary outcomes:
measure: Pre-operative Range of Motion (ROM)
timeFrame: baseline
measure: Post-operative Range of Motion (ROM)
timeFrame: 1 year post-operatively
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Taunton, MD
role: PRINCIPAL_INVESTIGATOR
References: