louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01908218: The Reliability and Validity of the Upper Lip Bite Test to Predict Difficult Laryngoscopy in Korean
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orotracheal Intubation
Keywords: ULBT, diffficult laryngoscopy, Predictive Value of Tests
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 344
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients undergoing general anesthesia with orotracheal intubation

Brief summary: Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper management.

Several methods to evaluate the anatomical structures has been used during preoperative period for airway assessment.

Evaluation methods are such as the Mallampati classification, mouth opening, thyromental distance and sternocostal distance.

the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper lip by the lower incisor.

The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT) in Korean compared to Modified Mallampati classification(MMT).


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing general anesthesia with orotracheal intubation

Exclusion Criteria:

* patient who have facial anomaly , 2. patients who required a rapid sequence induction

Primary outcomes:
measure: Cormack and Lehane grade
timeFrame: glottis view with direct laryngoscopy for 1 minute during anesthesia induction
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kwandong university colloge of medicine
Study officials:
References:
citation: Kim JC, Ki Y, Kim J, Ahn SW. Ethnic considerations in the upper lip bite test: the reliability and validity of the upper lip bite test in predicting difficult laryngoscopy in Koreans. BMC Anesthesiol. 2019 Jan 10;19(1):9. doi: 10.1186/s12871-018-0675-5.
Clinical trial NCT01535313: Comparison of a Powered Bone Marrow Biopsy Device With a Manual System
Official title: a Prospective Randomized Controlled Trial Comparing a Powered Bone Marrow Biopsy Device With a Manual System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Biopsy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness is improved with a powered bone marrow biopsy device in comparison with a manual device.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* \>= one previous bone marrow procedure
* INR \> 1.4
* tThrombocyte count \> 10 x109/l
* informed consent signed

Exclusion Criteria:

* cognitive impairment
* excessive tissue at anatomical landmarks
* BMI \> 35 kg/m2
* allergy to premedication
* unable to lay flat in prone position

Primary outcomes:
measure: Diagnostic usefulness (yes/no) of biopsy cylinder
timeFrame: within 1 week of biopsy
Secondary outcomes:
measure: patient pain during procedure
timeFrame: day 1 (two time points) and day 3-5
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christoph M Bucher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06081413: Bariatric and Metabolic Surgery in Patients Over 65 Years of Age
Official title: Bariatric and Metabolic Surgery in Patients Over 65 Years of Age - a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes Mellitus, Type 2
Hypertension
Keywords: bariatric surgery
elderly patients
obesity-related diseases
Lead sponsor: University of Warmia and Mazury in Olsztyn
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 284
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients over 65 years of age who underwent bariatric procedures

Brief summary: A retrospective multicenter study that will analyze the results of surgical treatment of obesity in patients over 65 years of age.


Eligibility criteria: Inclusion Criteria:

* 65 years of age and more
* undergone bariatric surgery

Exclusion Criteria:

* lost to follow up

Primary outcomes:
measure: weight loss after bariatric surgery
timeFrame: until December 31, 2022
measure: improvement in obesity-related diseases
timeFrame: until December 31, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Olsztyn
country: Poland
facility: UWM
Study officials:
References:
Clinical trial NCT02301013: Impact of Urethral Mobility on the Success of Sling Operations
Official title: Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 140
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Main objective is to evaluate the relation between the increased urethral mobility and unsuccessful treatment after TVT and TOT operations.

140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses.Female patients of 25 to 70 years of age who are positive for stress test will be included.

All patients will be questioned for parity, body mass index, menopausal state, medical history, and examined for POP-Q stage, urodynamy, stress test, UDI 6, IIQ7 and with transperineal sonography preoperatively. "Passive mobility angle" and "active mobility angle" will be measured.

The relationship between passive mobility angle or active mobility angle and success of sling operations will be determined in this study.

Detailed description: Transperineal sonography will be performed in a 300 cc filled bladder state, on a horizon which connects the lower margin of the pubic bone and the lower side of the urethral part of the bladder. First measurement will be done on litotomy position in resting state, second on 45 degrees reverse trandelenburg position in resting state and third one on 45 degrees reverse trandelenburg position in maximal valsalva straining state. The alteration between the angles measured at resting litotomy position and the resting reverse trandelenburg position is named as "passive mobility angle" (trigger gap) and the angle measured between the trigger gap and maximal valsalva state is named as "active mobility angle". Furthermore, post voiding residues have also been measured by transperineal ultrasonography.

Eligibility criteria: Inclusion Criteria:

* 140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses between March 1, 2013 and January 1, 2015 in Kanuni Sultan Suleyman Medical Research and Educational Hospital.

Exclusion Criteria:

* Patients with level 3 or higher level of uterine descensus, previous urinary incontinence surgery, overactive bladder and who are unwilling for randomization will not been included.

Primary outcomes:
measure: Subjective Success of Sling Operations
timeFrame: 6 months
Secondary outcomes:
measure: Objective Success of Sling Operations
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Kucukcekmece
Study officials:
References:
Clinical trial NCT04706013: Oral Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency
Official title: Study of Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency
Lead sponsor: Medicure
Sponsor class: INDUSTRY
First posted: 2021-01-12
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed clinical study is intended to evaluate oral P5P for the treatment of patients confirmed to have Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency via genetic analysis. There is an unmet clinical need for pharmaceutical grade P5P, as to date none has been made commercially available. Patients will receive pharmaceutical grade P5P according to their normal oral P5P dosing regimen, as previously established by their physicians.


Eligibility criteria: Inclusion Criteria:

1. Patients with confirmed PNPO deficiency via genetic analysis, whose seizures are typically controlled on P5P (oral) therapy.

   a. Typically controlled is defined as receiving multiple doses of P5P daily to control seizures. Receiving P5P for a minimum of 30 days.
2. Male and/or female patients.
3. Patients with previous failed treatment on pyridoxine are eligible for the study (patient should be off pyridoxine for at least 24 hours).
4. Written informed consent (by parent or guardian if under the age of 18).

Exclusion Criteria:

1. The patient has any condition or abnormality which may, in the opinion of the Investigator, compromise the safety of the patient, or influence their ability to comply with study procedures.
2. Known or suspected allergy to the trial drug or the relevant drugs given in the trial.
3. Involvement in a clinical research study within 4 weeks prior to screening and/or prior enrollment in the study. Participation in observational registry studies is permitted.

Primary outcomes:
measure: Overall survival time (time to death), including incidence of death at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of seizures (including but not limited to status epilepticus)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke Children's Hospital
state: North Carolina
city: Akron
country: United States
facility: Akron's Children's Hospital
state: Ohio
city: South Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
Study officials:
References:
Clinical trial NCT00514813: Dynepo Long-Term Safety Study
Official title: An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Kidney Failure, Chronic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.


Eligibility criteria: Inclusion Criteria:

1. Patients who complete Dynepo study SPD490-301.
2. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301.

Exclusion Criteria:

1. Withdrawal, before Week 24, from study SPD490-301.
2. Pregnant or lactating women.
3. Uncontrolled hypertension.
4. Thrombocytopenia (platelet count \<75,000/mm3).
5. Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
6. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.
7. Androgen therapy in the 30 days immediately prior to enrolment in this study.
8. Known Human Immunodeficiency Virus (HIV) infection.
9. History of hypersensitivity to Dynepo.
10. Known to have Ab against EPO.

Primary outcomes:
measure: Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Over the course of 2 Years
Secondary outcomes:
measure: Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years
timeFrame: Baseline and 2 years
measure: Change From Baseline in Hematocrits at 2 Years
timeFrame: Baseline and 2 years
Other outcomes:
Locations:
city: Lier
country: Belgium
facility: Heilig Hartziekenhuis Department of Nephrology
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02254213: Intra-individual Stability in Electroencephalography (EEG) Parameters
Official title: Intra-individual Stability in EEG Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stability of EEG Features in Humans
Keywords: Intra-individual stability, EEG
Lead sponsor: Mentis Cura
Sponsor class: INDUSTRY
Collaborators: name: The Icelandic Center for Research
First posted: 2014-10-01
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15 individuals in the age range of 50 - 90 years.

Brief summary: The main objective is to evaluate the stability of EEG features on an individual level.


Eligibility criteria: Inclusion Criteria:

* Age must be in the range 50 - 90 years

Exclusion Criteria:

* Outside required age range

Primary outcomes:
measure: Quantitative EEG (qEEG) features
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mentis Cura
name: Kristinn Johnsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.
Clinical trial NCT00122213: A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
Official title: An Individual-based Diet and Physical Activity Intervention Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retirement
Weight Gain
Keywords: Prevention
Retirement
Physical activity
Diet
Weight gain
Body composition
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
First posted: 2005-07-21
Enrollment: 400
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Advancing age in itself is associated with changes in body composition. However, during transitional life stages, such as retirement, detrimental changes on diet and physical activity may occur. This might lead to weight gain and accumulation of abdominal fat.

To prevent these changes, participants receive a low-intensity intervention on energy balance and related behaviours.

After six months, one and two years, the effects will be studied by comparing the intervention group with the control group.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy and recently retired

Exclusion Criteria:

* Using drugs that might influence body composition, digestion or physical activities

Primary outcomes:
measure: Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure)
measure: Energy intake (Food Frequency Questionnaire)
measure: Physical activity level (Physical Activity Scale for the Elderly)
Secondary outcomes:
measure: Psychosocial factors (attitude, social influence, self-efficacy etc.)
Other outcomes:
Locations:
Study officials:
affiliation: Wageningen University - Division of Human Nutrition
name: Evert G Schouten, PhD
role: STUDY_CHAIR
References:
citation: Werkman A, Hulshof PJ, Stafleu A, Kremers SP, Kok FJ, Schouten EG, Schuit AJ. Effect of an individually tailored one-year energy balance programme on body weight, body composition and lifestyle in recent retirees: a cluster randomised controlled trial. BMC Public Health. 2010 Mar 5;10:110. doi: 10.1186/1471-2458-10-110.
Clinical trial NCT01912313: Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)
Official title: Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IBS
Healthy
Keywords: IBS patients
healthy subjects
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 99999999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Rectal biopsies from IBS patients or healthy subjects will be taken.

Biopsies will be used for:

1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and Calcium imaging; 1.2 immunohistochemistry; 1.3 mRNA (Messenger ribonucleic acids) isolation and real time PCR (Polymerase chain reaction);
2. culturing biopsies

On the basis of these observations, the general aim of the study is to move a significant step forward in the current knowledge on human ENS (enteric nervous system) in IBS by establishing a live imaging method to record enteric nerves activity in small intestinal biopsies from humans. This development is unique in its kind as not other research groups have reported successful live recordings with calcium imaging in this preparation.

In particular, the investigators aim:

1. to develop and validate the technique to measure activity in human enteric nerves in the submucous plexus isolated from rectal biopsies from healthy subjects and IBS patients;
2. to characterize this nerve activity in healthy subjects and IBS patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtPCR to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia;
3. to investigate whether the biopsies of IBS patients secrete more modulators/cytokines compared to healthy subjects and their potential to activate neurons.
4. to evaluate the influence of different food constituents (cow"s milk, wheat, yeast, gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell activation/degranulation in biopsies of IBS patients compared to healthy subjects.
5. To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS patients and healthy volunteers by the use of metabolic profiling


Eligibility criteria: Inclusion Criteria:

* IBS patients (based on ROME III Criteria)
* Healthy subjects

Exclusion Criteria:

- All subjects with not IBS related complaints

Primary outcomes:
measure: nerve activity in healthy subjects and IBS patients
timeFrame: Starting from the moment biopsies are collected untill nerve activity in samples is lost (approximately 5 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Catholic University Leuven and Universitary Hospitals Leuven
name: Guy Boeckxstaens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03935113: Effects of Kinesio Taping for Upper Limb Function of Stroke Patients
Official title: Effects of Kinesio Taping for Upper Limb Function of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with stroke in the brain, due to central nervous system damage, lack of correct action patterns, limited joint movement of upper limbs, affecting the patient's performance. The Kinesio taping effect is to facilitate the muscle activity of upper limb. This program is intended to provide a treatment for patients with chronic stroke, and to observe their upper limb movements before and after using the Kinesio taping.

Detailed description: Motor impairment is the main cause of disability after stroke, leading to major health problems. Research has shown that the most common consequence of stroke is the paresis of limbs.The ability to live independently after a stroke depends on the recovery of motor functions,particularly those of the upper limb.The core concept of the Kinesio taping is to influence the brain through the sensory input, stimulate the nervous system, and improve the motor performance of the stroke patient.

Eligibility criteria: Inclusion Criteria:

* Post-stroke hemiplegia, at least 6 months since onset
* Ability to communicate and understand instructions.

Exclusion Criteria:

* Skin problems, wounds, or infection on the affected upper limb.
* The experience of using the Kinesio taping.
* A history of allergy tothe Kinesio taping.

Primary outcomes:
measure: Change in Fugl-Meyer Assessment (FMA) from pre to post-intervention.
timeFrame: up to 30 minutes.
measure: Change in Action Research Arm Test (ARAT) from pre to post-intervention.
timeFrame: up to 30 minutes.
measure: Change in Box and Block Test (BBT) from pre to post-intervention.
timeFrame: up to 30 minutes.
Secondary outcomes:
measure: Change in Motor Activity Log (MAL) from pre to post-intervention.
timeFrame: up to 20 minutes.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wang Fang hospital
state: Taipei City
Study officials:
References: