louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06193291: Effect of Hot Water Immersion on Heart Rate Variability and Glucose
Official title: Effect of Hot Water Immersion on Heart Rate Variability (HRV) and Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Tolerance
HRV
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Heat therapy has been shown to reduce risk of various diseases, including heart disease, alzheimers, and pneumonia, as well as all-cause mortality . A previous study found heating a single hand lowers postprandial blood glucose levels with a magnitude similar to certain exercise interventions such as 40 minutes of slow walking We propose that heating both feet and heating both legs up to the calves will result in similar glucose reductions in a dose response manner.Overview To determine the effect of heating both feet to the ankles and heating both legs to the calves on postprandial blood glucose


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years

Exclusion Criteria:

* previously diagnosed diabetes

Primary outcomes:
measure: Blood Glucose
timeFrame: 120 min
Secondary outcomes:
measure: Heart rate variability
timeFrame: 120 min
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References:
citation: Laukkanen JA, Laukkanen T, Kunutsor SK. Cardiovascular and Other Health Benefits of Sauna Bathing: A Review of the Evidence. Mayo Clin Proc. 2018 Aug;93(8):1111-1121. doi: 10.1016/j.mayocp.2018.04.008.
citation: Kimball AL, McCue PM, Petrie MA, Shields RK. Whole body heat exposure modulates acute glucose metabolism. Int J Hyperthermia. 2018;35(1):644-651. doi: 10.1080/02656736.2018.1516303. Epub 2018 Oct 10.
citation: Moore J, Kressler J, Buono MJ. Hand heating lowers postprandial blood glucose concentrations: A double-blind randomized controlled crossover trial. Complement Ther Med. 2020 Mar;49:102280. doi: 10.1016/j.ctim.2019.102280. Epub 2019 Dec 12.
Clinical trial NCT02009891: Use of Predictive Model to Assist Patients Having an Embryo Transfer After IVF
Official title: The Application of a Validated Patient and Clinic Specific Predictive Model to Reduce the Incidence of Multiple Births Resulting From Fresh In Vitro Fertilization Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: predictive model
in vitro fertilization
elective single embryo transfer
Lead sponsor: Ottawa Fertility Centre
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women under age 38 undergoing 1st or 2nd IVF treatment who havae not had previous IVF pregancy nor cancelled IVF cycle for poor response.

Brief summary: To determine in women undergoing IVF who are at high risk of multiple births (\>35%), as calculated by the application of a predictive model - IVFsingleTM, if single embryo transfer will lead to both comparable clinical pregnancy rate (CPR) and other secondary outcomes such as live birth rate (LBR) and cumulative live birth rate (cLBR) in comparison to DET while reducing the incidence of multiple births (a secondary outcome measure).


Eligibility criteria: Inclusion Criteria:

Under 38 1st or second IVF attempt

-

Exclusion Criteria:

Over 37 years old donor egg third or greater IVF attempt cancellation in previous cycle for poor response successful pregnancy with IVF -

Primary outcomes:
measure: Clinical pregnancy rate at 8 -10 weeks gestational age
timeFrame: 36 months
Secondary outcomes:
measure: Multiple pregnancy rate
timeFrame: 36 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Fertility Centre
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Arthur Leader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02214680: The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter
Official title: The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Healthy
Keywords: Pupil diameter
Brimonidine
Timolol
Combigan
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.

Detailed description: In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.

The study subjects will be examined twice, two weeks apart. On the first exam the subject will receive Combigan eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.

Eligibility criteria: Inclusion Criteria:

* Healthy adults subjects with no ocular pathology
* Non pregnant women
* Normal pupil response

Exclusion Criteria:

* Chronic topical treatment
* Systemic medication affecting autonomic nerve system
* History of intra-ocular surgery
* Irregular pupil
* History of ocular neurological or severe cardio-vascular disease

Primary outcomes:
measure: Pupil diameter
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Orna Geyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05194280: Comparison of Robot-assisted Donornephrectomy vs Hand-assisted Laparoscopic Donornephrectomy
Official title: Robot-assisted Donornephrectomy: Initial Results and Comparison With the Hand-assisted Laparoscopic Technique: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Donation
Robotic Surgery
Keywords: Donornephrectomy
Robotic-asisted donornephrectomy
hand-assisted laparoscopic donornephrectomy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney donors

Brief summary: The aim of this retrospective study was to analyze donor and recipient outcomes after robotic-assisted donor nephrectomy and hand-assisted laparoscopic donornephrectomy.

Detailed description: Living donor kidney transplantation is superior to cadaveric kidney transplantation because of the better patient and graft survival rates, better cost-effectiveness and improved quality of life of the recipient. According to the current guidelines, the laparoscopic technique of donor nephrectomy is now recommended as "the preferential technique". The advantages of the hand-assisted laparoscopic donor nephrectomy (HALDN) as compared with the conventional laparoscopy include tactile feedback, less kidney traction, rapid kidney removal and a shorter warm ischemic period. HALDN is nowadays the most frequently used technique in the U.S. for living donor nephrectomy. The laparoscopic techniques may have helped to increase the expansion of the donor pool. However, laparoscopic surgery have some disadvantages especially ergonomic inconveniences for the surgeon, which may result in decreased surgeons' performance and musculoskeletal disorders. Surgical robotics can play a role in extending surgical careers, by allowing surgeons to perform high volume laparoscopic surgery in a more ergonomic way. Robotic assistance in living donor nephrectomy can offer improved safety by enhanced control, accuracy, stability, and vision. The aim of this retrospective study was to compare the robotic assisted donor nephrectomy (RADN) with the HALDN technique with respect to donor and recipient outcomes.

Eligibility criteria: Inclusion Criteria:

* Adult, healthy condition

Exclusion Criteria:

* Children, not suitable for kidney donation

Primary outcomes:
measure: Post-operative pain score
timeFrame: 0-3 days
Secondary outcomes:
measure: Operating time
timeFrame: 30-300 min
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Mirza Idu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03705780: Fentanyl Test and A Short OSAS Screening Scale for Severe Obstructive Sleep Apnea
Official title: Comparison of Preoperative Fentanyl Test and A Short OSAS Screening Scale for Identifying Severe Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: fentanyl
OSAS screening scale
adenotonsillectomy
diagnose
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 104
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to estimate and compare the value of the preoperative fentanyl test and the short OSAS screening scale to diagnose severe obstructive sleep apnea；and to observe the required amount of hydromorphone and the adverse respiratory events after adenotonsillectomy.

Detailed description: The results of polysomnography were obtained before adenotonsillectomy, and the short OSAS screening scale was completed by the subjects' parents in preoperative interview. All children were induced by sevoflurane inhalation. After eyelash reflex disappeared and pharyngeal airway insertion, giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable, observing the changes of respiratory rate. Severe OSAS was diagnosed as respiratory rate decreased by more than 50%. Anesthesia was maintained with desflurane and 60% nitrous oxide in oxygen. The children were transferred to the PACU after extubation. The postoperative pain and agitation were assessed according to the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and The Pediatric Anesthesia Emergency Delirium (PAED) score, and all children were given hydromorphone for pain relief according to our protocol.

Eligibility criteria: Inclusion Criteria:

1. The American society of anesthesiologists (ASA) class Ⅰ \~ Ⅱ
2. Age greater than or equal to 3 years
3. Children were diagnosed by polysomnography and plan to adenotonsillectomy.

Exclusion Criteria:

1. craniofacial malformations
2. mental retardation
3. BMI \> 30 kg/m2
4. Combined with other neuromuscular diseases
5. a recent history of opioid use

Primary outcomes:
measure: Sensitivity， specificity ，positive predictive value and negative predictive value，likelihood ratio
timeFrame: 5 months
Secondary outcomes:
measure: hydromorphone requirement in PACU
timeFrame: 50 minutes after extubation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Chilren's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xuan Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03423680: A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Official title: A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Depression, Bipolar
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 390
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features.

This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 19 and \< 70 years at the time of informed consent
* Patients who are able to understand information required for providing a consent
* Patients who have received a mood stabilizer (lithium or valproic acid)
* Patients with bipolar I or II disorder accompanied by major depressive episode
* Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits

Exclusion Criteria:

* Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features
* Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history

Primary outcomes:
measure: Mean change in the Montgomery-Åsberg Depression Rating Scale total score
timeFrame: Week 8
Secondary outcomes:
measure: Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score
timeFrame: Week 8
measure: Response rate
timeFrame: Week 8
measure: Remission rate
timeFrame: Week 8
measure: Percentage of subjects with Clinical Global Impression-BP version Severity of Illness (Depression) score of 1 or 2
timeFrame: Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seounl National University Hospital
Study officials:
References:
Clinical trial NCT04064580: Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve
Official title: Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Pathology
Obstructive Syndrome
Keywords: capnography
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 300
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: Major patient requiring spirometry breathing functional exploration

Brief summary: Obstructive respiratory diseases such as asthma or COPD are a common reason for emergency room visits. Currently, nasal gill capnography and oxygen saturation measurement (SpO2) are the only two non-invasive means of continuously monitoring a respiratory pathology. To date, Respiratory Functional Explorations (CFE) and more particularly spirometry, are considered as the reference examinations for the diagnosis or monitoring of asthma or COPD. However, physical and physical constraints make their use almost impossible in the context of the emergency with patients presenting to emergencies in respiratory distress, often require oxygen therapy or even non-invasive ventilation. Only pulmonary auscultation can make the diagnosis of acute decompensation of obstructive pathology. This technique is qualitative and imprecise, sometimes leading to a diagnostic uncertainty resulting in delay in taking charge and inappropriate therapy.

Studies have shown a change in the capnography curve in obstructive airway disorder and a strong correlation between some capnography parameters and spirometry parameters such as the Tiffeneau ratio (FEV1 / FVC), suggesting capnography as a simple and effective technique for the diagnosis of obstructive syndrome of patients in emergencies.


Eligibility criteria: Inclusion Criteria:

* Major patient male or female
* Patient with respiratory disease with and without obstructive syndrome or patient without respiratory pathology
* Patient requiring spirometry breathing functional exploration
* Subject affiliated to a social health insurance scheme
* Subject able to understand the objectives and the risks related to the research and to give its non opposition

Exclusion Criteria:

* Pregnant and lactating woman
* Patient not affiliated to a social protection scheme
* Subject in exclusion period (determined by previous or current study),
* Impossibility of giving the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...)
* Subject under the protection of justice Subject under guardianship or curatorship

Primary outcomes:
measure: Spirometry measurement
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT04843280: Traditional PT v Internet Based PT After Total Knee Arthroscopy
Official title: Comparison of Traditional Physical Therapy to Internet-Based Physical Therapy After Knee Arthroscopy: A Prospective Randomized Controlled Trial Comparing Patient Outcomes and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee arthroscopy results in significant improvements in functional outcomes, pain relief and quality of life for patients suffering from mechanical symptoms associated with meniscal tears. Patients are able to return to their activities of daily living, occupation, or sport without significant limitations. Traditionally, patients have undergone formal physical therapy (PT) after knee arthroscopy to regain function. There is a significant cost and time commitment associated with traditional outpatient physical therapy. An internet based therapy program allows patients to perform therapy at home on their own time schedule. A recent study demonstrated that patients who undergo internet based PT after total knee arthroplasty performed as well patients receiving traditional physical therapy. These findings have not been studied in the knee arthroscopy patient population. The goal of this study is to compare traditional outpatient physical therapy rehabilitation to Internet-based rehabilitation in patients undergoing knee arthroscopy for partial meniscectomy.

The purpose of this study is to compare functional outcome, and patient satisfaction, internet-based rehabilitation program vs. standard outpatient physical therapy after unilateral knee arthroscopy for meniscal tear.


Eligibility criteria: Inclusion Criteria:

* Any patient undergoing unilateral primary knee arthroscopy for meniscal tear
* Any patient 18 years or older

Exclusion Criteria:

* Patients without access to the Internet
* Post-traumatic osteoarthritis
* Patients with ligamentous injury
* Patients with full thickness cartilage defects
* Patients with osteoarthritis or inflammatory arthritis
* Revision or conversion knee arthroscopy
* Patients receiving workers compensations
* Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.

Primary outcomes:
measure: Postoperative Knee Function
timeFrame: 4 months
measure: Cost analysis
timeFrame: 4 months
measure: Postoperative Physical therapy Patient Satisfaction
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02747680: Cerebral Responses to Insulin Induced Hypoglycemia
Official title: Cerebral Responses to Insulin Induced Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Healthy
Hypoglycemia Unawareness
Keywords: type 1 diabetes
hypoglycemia unawareness
healthy control
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.

Detailed description: The purpose of this study is to better understand the effect of low blood sugar (hypoglycemia) on blood flow and biochemistry in the brain. Hypoglycemia is a serious complication of diabetes treatments. It has been previously observed that hypoglycemia causes an increase in blood flow to certain parts of the brain, but it has been difficult to determine which parts of the brain specifically have an increase in blood flow. With new technology, it is now possible to determine the rate of blood flow in very small parts of the brain. The investigator expects that people with type 1 diabetes and hypoglycemia unawareness, poorly controlled diabetes, and normal subjects will have different rates of blood flow to different parts of the brain in response to hypoglycemia. Having a greater understanding of how the brain adapts to hypoglycemia may help us develop better ways to treat diabetes more safely.

Eligibility criteria: Inclusion Criteria:

* well controlled type 1 diabetes (hemoglobin A1C \<7.5%)
* healthy controls

Exclusion Criteria:

* History of stroke, seizures, neurosurgical procedures, or arrhythmias
* Use of drugs that can alter GABA (gamma-aminobutyric acid) metabolism (such as benzodiazepines).
* Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.

Primary outcomes:
measure: Brain activation during euglycemia (normal blood sugar) using functional MRI
timeFrame: baseline
measure: Brain activation during hypoglycemia (low blood sugar) using functional MRI
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Elizabeth Seaquist, MD
role: PRINCIPAL_INVESTIGATOR
References: