louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04832529: A Perianal Abscess Cavity Packing vs no Packing.
Official title: A Perianal Abscess Cavity Packing Versus no Packing; a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perianal Abscess
Ischiorectal Abscess
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: This prospective randomized trial will be conducted in all patients undergoing packing or no packing for perianal abscess cavity after incision and drainage, for 6 months after approval from IRB in Surgical unit III, Civil Hospital Karachi. Patient will be selected simple random sampling technique based on inclusion criteria. Patient will be assessed for post-operative pain, healing of cavity and recurrence of abscess. At first time of debridement pus or tissue will be sent for culture and sensitivity, meanwhile broad-spectrum antibiotic will be started.

Questionnaire will be filled by PI for post-operative pain, recurrence of abscess, quality of life, wound healing, post operative fistula in ano and chronic post surgical pain either due to packing or no packing.

Detailed description: This is an experimental randomized control trial will start 6 months after approval from Institution Review Board. All patients with perianal abscess after incision and drainage cavity will be either packed or not after informed consent. Pack will be changed daily as regular dressing till healing occurs. Packing reduces bleeding and heals cavity by effect of dressing solution in which gauze is soaked. Other group with dressing will be changed daily and will be assessed for healing week. There is no pain in simple dressing applied over cavity. Patient will receive broad spectrum antibiotics according to pus or tissue culture. During this period, laboratory investigation CBC, CRP will be sent to check the response. Sits bath will be advised to both groups. Post-operative pain, cavity healing will be assessed by faculty.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Age less than 70 years
* Perianal abscess

Exclusion Criteria:

* Suspected inflammatory bowel disease
* Fournier's gangrene
* Horseshoe/bilateral abscess

Primary outcomes:
measure: Post-operative pain
timeFrame: 14 days
Secondary outcomes:
measure: Decreases hospital visit
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr Ruth K.M Pfau Civil Hospital
state: Sindh
Study officials:
References:
Clinical trial NCT00216229: Twinrix Alternative Schedule Study
Official title: A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antibody Response After Vaccination
Keywords: combined hepatitis A and B vaccine
hepatitis B virus
immunity
Lead sponsor: IDEWE Occupational Health Services
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-22
Enrollment: 400
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: To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months.

1. To compare the seroconversion (\>= 1 IU/l) and seroprotection (\>= 10 IU/l) rate at month 6,7,12 and 13.
2. To compare the distribution of anti-HBs at these different moments.


Eligibility criteria: Inclusion Criteria:

* 18 years or older;
* a good physical condition as confirmed by history and physical examination at entry of the study;
* for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen;
* all participants have provided written informed consent.

Exclusion Criteria:

* Employees occupationally exposed to hepatitis B virus
* Other exclusion criteria listed for the vaccine (licensed vaccine):
* Each acute disease at the inclusion in the study;
* A history of hypersensibility to one of the components of the vaccine;
* Simultaneous participation in another clinical trial

Primary outcomes:
measure: Anti-HBs antibodies concentration 1 month after 3th vaccine dose
Secondary outcomes:
measure: Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: IDEWE
Study officials:
affiliation: IDEWE Occupational Health Services
name: Antoon A De Schryver, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06848829: Difference of Tear Ferning Between Women with and Without Menopausal.
Official title: Difference of Tear Ferning Between Pre-and Post-menopausal Women and Between Post-menopausal Women with or Without Hormone Replacement Therapy (HRT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: Dry Eye diagnosis
Tear ferning
menopause
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Application of tear ferning test for clinical dry eye diagnosis and menopause

Detailed description: Analyzing the difference in tear ferning structure between women pre and post-menopause with and without hormone replacement therapy (HRT). Tear and blood samples were collected for a menopause-related Enzyme-linked immunosorbent assay. Tear volume, tear osmolarity, intraocular pressure, and tear break-up time were also measured for comparison.

Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 65 years

Exclusion Criteria:

* No evident ocular diseases such as cornea, cataracts, vitreous degeneration, glaucoma, and retinopathy.
* Belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Primary outcomes:
measure: Schirmer's test
timeFrame: 5 minutes
measure: Tear film breakup time
timeFrame: 20 seconds
measure: Ocular surface status
timeFrame: 3 minutes
measure: Tear ferning
timeFrame: 30 minutes
measure: Menopause related hormone Enzyme-linked immunosorbent assay (ELISA)
timeFrame: 3 hours
Secondary outcomes:
measure: Ocular surface disease index
timeFrame: 20 minutes
measure: Intraocular pressure
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Jen-Ai Hospital
Study officials:
References:
Clinical trial NCT02150629: Investigating Kinematic and Electromyographic Changes After SCI and Their Relation to Clinical and Functional Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal cord injury patients and healthy control subjects

Brief summary: The study aims at discerning specific gait patterns and elucidating locomotor control of spinal cord injured patients in order to find sensitive kinematic and electromyographic outcome measures that are able to reveal information on underlying mechanisms of normal and aberrant gait control and its recovery over time. These measures may also be used to compare the outcome across different neurological disorders.


Eligibility criteria: Inclusion Criteria:

Patients: We will monitor patients who were admitted to the Spinal Cord Injury Center of the University Hospital Balgrist. We will record patients with various aetiologies, grades of impairment and types of spinal cord lesions. Patients need to have minimal voluntary motor capacities: the motor scores of the key muscles according to the ASIA classification (www.asia-spinalinjury.org) should be at least 3 for extensor muscles and 2 for flexor muscles. Written informed consent is required. Control subjects: Healthy subjects, written informed consent.

Exclusion Criteria:

Patients: Comorbidities which influence or inhibit gait or upper-limb motion (e.g. peripheral nerve lesions). Orthostatic problems that greatly impair upright body position. Mental illness, cognitive impairments. Control subjects: neurologic disease, walking disabilities, mental illness, cognitive impairments

Primary outcomes:
measure: Change of gait kinematics after spinal cord injury over one year
timeFrame: 1) very acute: 0 - 14 days after injury; 2) acute I: 2 - 4 weeks post-injury; 3) acute II: 4 - 12 weeks post-injury; 4) acute III: 12 - 24 weeks post-injury; 5) chronic: 24 - 48 weeks post-injury
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
References:
Clinical trial NCT01695564: Safety and Efficacy of Left Atrial Appendage Occlusion Devices
Official title: Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial enlargement
left atrial appendage
Lead sponsor: Kansas City Heart Rhythm Institute
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had a LARIAT LAA device occlusion.

Brief summary: Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In the last two decades the number of hospitalizations for AF has increased two- to three-fold. More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke compared with those without AF.

This registry will collection information on two devices that are used to treat AF. The WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices on outcomes related to AF has not been studied. This study will look to compare the two devices to see how the outcomes may vary.


Eligibility criteria: Inclusion Criteria:

* Patients who have had a LARIAT LAA device occlusion

Exclusion Criteria:

* Patients who have PFO/ASD/critical carotid artery (\>70% blockage) disease and hemorrhagic strokes

Primary outcomes:
measure: Effect of LAA occlusion by LARIAT device
timeFrame: Change from Day 0 to Day 90
measure: Effect of LAA occlusion by LARIAT device
timeFrame: Change from Day 0 to 356 post-procedure
Secondary outcomes:
measure: Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities
timeFrame: Days 0, 90, 180, 365 post-procedure and annually thereafter
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00602264: Adipokines and Ghrelin Concentrations in Different Stages of Anorexia Nervosa
Official title: Adipocytokine and Ghrelin Concentrations in Different Stages of Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Adipokines
Keywords: Anorexia nervosa
Adipokines
Ghrelin
Fat mass
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 41
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 32
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with anorexia nervosa and constitutionally thin healthy subjects

Brief summary: The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.

Detailed description: Objective: The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.

Design: The study group is composed of four groups. Group1: Treatment-naïve patients with a recent diagnosis of AN (n:19), Group 2: The weight recovered (10 % increase in body weight compared with baseline weight) subgroup of group 1 at the end of a mean 117.72±98.14 days of follow-up (n: 12), Group 3: Recovered patients with a previous history of AN but normal menstrual cycles and body weight at the present time (n:10), Group 4: Control group: constitutionally thin healthy young women with normal menstrual cycles (n:10). Venous blood was obtained for measurements of biochemical parameters, ApN, leptin and ghrelin and body composition was determined by bioimpedance analysis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of anorexia nervosa for Group 1-3
* Constitutionally thin healthy subjects for Group 4

Exclusion Criteria:

* Medical or psychiatric diagnosis other than anorexia nervosa,
* History of gastrointestinal disease for Group 1-3
* History of eating disorder or gastrointestinal or psychiatric disease for control group

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Univetsity, Istanbul Medical Faculty, Department of Psychiatrics
Study officials:
affiliation: Istanbul University Istanbul Medical Faculty Department of Endocrinology and Metabolism
name: Ayse Kubat Uzum, M.D
role: STUDY_DIRECTOR
affiliation: Istanbul University Istanbul Medical Faculty Department of Psychiatrics
name: Basak Yucel, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Istanbul Medical Faculty Department of Biochemistry
name: Beyhan Omer, Professor
role: STUDY_CHAIR
affiliation: Istanbul University Istanbul Medical Faculty Department of Endocrinology and Metabolism
name: Nese Colak Ozbey, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06395064: The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial
Official title: The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gynecologic Neoplasm
Healthy Women
Keywords: post-operative nausea vomiting
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 160
Sex: FEMALE
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: The aim of this clinical trial is to learn if Dimenhydrinate works to prevent postoperative nausea-vomiting in adult women who undergoing abdominal hysterectomy. The primary question is: Does Dimenhydrinate lower the proportion of postoperative nauseavomiting during the day 1 after surgery. Researcher will compare Dimenhydrinate to a placebo (a-look-alike substance that contains no drug) which will give intravenously when the patient come back to the ward, to see if Dimenhydrinate work to prevent nauseavomiting during the postoperative day1. All participants will receive standard treatment during pre-operative, intra-operative and the immediate post-operative periods. Participants will receive Dimenhydrinate or placebo only one dose after discharge from the recovery room. During the day 1 postoperative, participants will report their symptoms and keep a diary of the number of tmes they use additional anti-emetic drugs.


Eligibility criteria: Inclusion Criteria:

* 18-65 years female
* undergoing trans abdominal hysterectomy

Exclusion Criteria:

* undergoing emergency surgery
* pregnancy or breastfed women
* post delivery less than 6 weeks
* history of allergic reaction or precaution to use the protocol drug
* BMI less than 18 or more than 30 kg/m2
* Need ICU care after surgery

Primary outcomes:
measure: occurrence and times of nausea vomiting
timeFrame: at ward, 6, 12, 24 hr postoperation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03138590: Investigating Accelerated Learning in Healthy Subjects: Trigeminal Nerve Stimulation
Official title: Investigating Accelerated Learning in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Adults
Keywords: transcranial Direct Current Stimulation (tDCS)
accelerate learning
memory
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be randomly assigned to one of 2 groups: (1) active tDCS (2) sham tDCS
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate learning task

Detailed description: Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. To investigate whether it is possible to accelerate learning and improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 2 groups will be compared. The first group will get active tDCS during the verbal paired-associate learning task. The second group will get sham tDCS during the verbal paired-associate learning task.

Eligibility criteria: Inclusion Criteria:

* Native English Speaker

Exclusion Criteria:

* History of severe head injuries, epileptic insults, or heart disease.
* Severe psychiatric disorders and severe untreated medical problems
* Acquainted with the foreign language used in the learning task
* Contraindications for tDCS (e.g. pregnant, implanted devices)

Primary outcomes:
measure: Associative Memory Assessed by a Verbal Paired-Associate Test
timeFrame: 1 week after stimualtion
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: The University of Texas of Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Sven Vanneste
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03159390: Metabolism of Ornithine Phenylacetate
Official title: Human Metabolism of Ornithine Phenylacetate: A Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: dietary supplements
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Ocera Therapeutics
First posted: 2017-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Intravenous infusion of stable tracers of ornithine, glutamine, glutamate, and glycine will be performed, and collect blood samples, urine samples, and muscle biopsies to evaluate the effect of a continuous oral intake of phenylacetate salt of ornithine (OP) on its metabolic fate.

Detailed description: The study involves 1 screening visit of approximately 1 hour and 4 study days of approximately 10 hours. The subject will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight and height will be measured and Dual-energy X-ray absorptiometry (DXA) will be performed to measure body composition. After 4 hours subjects received a continuous intravenous infusion with OP in a dosage of 1 g /h. Next to the stable tracers provided to determine OP metabolism, stable tracers of phenylalanine (PHE) and tyrosine (TYR) may be provided to determine the effect of OP on protein metabolism at plasma and muscle tissue level. This required 2 muscle biopsies and on 2 study days 1 set of stable tracer pulses.

Eligibility criteria: Inclusion criteria healthy subjects:

* Healthy male \& female according to the investigator's or appointed staff's judgment
* Age 40-70 years (to be comparable with patients with liver cirrhosis: average 54.1 +/- 9.4 years)

Exclusion Criteria

* Metabolic diseases including diabetes and hepatic or renal disorders
* Presence of acute illness or metabolically unstable chronic illness
* Failure to give informed consent
* (Possible) pregnancy
* Any other condition according to the PI or nurse that would interfere with the study or safety of the patient or influence the results
* Unwilling to stop taking nutritional protein supplements within 5 days before test day
* History of hypo- or hyper-coagulation disorders, including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime
* Currently taking anti-thrombotics (i.e. medical indication) and cannot stop for 3-7 days prior to test days
* Allergy to local anesthetic

Primary outcomes:
measure: metabolism of ornithine phenylacetate to glutamate and glutamine
timeFrame: 4 study days that are 8 hours each
Secondary outcomes:
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M University-CTRAL
state: Texas
Study officials:
affiliation: Texas A&M University
name: Marielle Engelen, PhD
role: PRINCIPAL_INVESTIGATOR
References: