louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01981590: Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
Official title: Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: breathing, heart failure, sleep apnea
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.

Detailed description: Purpose The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter advanced into the great veins.

Study Design This is a prospective, non-randomized, acute feasibility study.

Eligibility criteria: Inclusion Criteria:

* Subjects older than 18 years of age
* Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures and/or device implant.
* Subjects willing and able to give informed consent

Exclusion Criteria:

* Subject with a previously implanted transvenous lead, which is still present in the veins under study.
* Subject with evidence of phrenic nerve palsy.
* Subject with chronic obstructive pulmonary disease.
* Subject with a spinal cord stimulator.
* Subject needs to receive drugs that might interfere with patient perception.
* Subjects with medical conditions that would prevent study participation
* Subjects who are pregnant, nursing, or of child bearing potential and are not on a reliable form of birth control
* Subjects enrolled in concurrent studies which could confound the results of this study
* Subject is unable or unwilling to participate with study procedures

Primary outcomes:
measure: Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)
timeFrame: one hour
Secondary outcomes:
measure: Number of Patients With Response to Stimulation (Tidal Volume)
timeFrame: one hour
measure: Number of Patients With Observed Side Effects
timeFrame: From procedure to 2-4 weeks post-procedure
measure: Number of Observed Side Effects
timeFrame: From procedure to 2-4 weeks post-procedure
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Stichting Catharina Ziekenhuis
state: EJ
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna
Study officials:
affiliation: Karolinska Institute, department of Cardiology
name: Frieder Braunschweig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03449290: The Short-term Effects of Trunk Kinesio Taping on Trunk Muscle Endurance and Postural Stability in Healthy Young Adults
Official title: Assistant Professor, Physioterapist, PhD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kinesio Taping
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the short-term effects of trunk kinesio taping on trunk muscle endurance and postural stability in healthy young adults.


Eligibility criteria: Inclusion Criteria:

* Healthy young volunteers aged between 18-25 years

Exclusion Criteria:

* Having disc hernias, any spinal pain complaint, spinal deformity, history related to spinal surgery, vestibulopathy, musculoskelatal injuries related to ankle, knee and hip joints, orthopedic and/or neurological problems and allergy to the kinesio tape

Primary outcomes:
measure: Trunk muscle endurance
timeFrame: Change from Baseline taping at 1 hour after the taping
Secondary outcomes:
measure: Postural stability
timeFrame: Change from Baseline taping at 1 hour after the taping
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda TOPRAK CELENAY
role: STUDY_DIRECTOR
affiliation: Ankara Yildirim Beyazıt University
name: Nezehat Ozgul UNLUER
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Yildirim Beyazıt University
name: Taskin OZKAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06512090: Effects of LGI Steam Bread on Glycemia Control in T2DM in China
Official title: To Investigate the Effects of Low Glycemic Index（LGI）Related Steamed Bread on Glycemia Control, Islet Function in Patients With Type 2 Diabetes in China: A Single-center, Randomized, Open-label, Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabete Type 2
Lead sponsor: Shanghai Punan Hospital of Pudong New District
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a single-center, randomized, open, prospective, parallel-controlled, head-to-head comparison trial. To investigate the effects of low glycemic index（LGI）related steam bread on glycemic control，islet function in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Age ≥18yrs；
* Diagnosed as Type 2 Diabetes;
* Had been on a stable hypoglycemic regimen for at least 30 days prior to screening；
* HbA1c between 7.5% and 11.0% (both upper and lower limits included) in the 90 days prior to screening;
* Fasting C-peptide ≥1.0ng/ml in the 90 days prior to screening;
* Be willing to accept and adhere to LGI steamed bread as a staple food for at least 14 days

Exclusion Criteria:

* Diagnosed with type 1 diabetes, or secondary diabetes;
* Have clinically significant liver disease, moderate/severe kidney injury, or end-stage renal disease;
* Has unstable CV disorders, including heart failure (NYHA) class III or IV), intractable angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥105mmHg);
* An Acute Coronary Syndrome event (ACS) occurred within the 6 months prior to randomization

Primary outcomes:
measure: glucose at 120 mins
timeFrame: 120 minutes
Secondary outcomes:
measure: glucose at 60 mins
timeFrame: 60 minutes
measure: iAUC 120 minutes
timeFrame: 120 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Punan Hospital of Pudong New District
name: LianYong Liu, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04862364: Turkish Validation Study of Endometriosis Health Profile -30 (EHP-30) Test
Official title: Turkish Validation of Endometriosis Health Profile -30 (EHP-30) Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Engin Oral
First posted: 2021-04-28
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients between the ages of 18-45 who were surgically diagnosed with endometriosis in our clinic will be included in the study. Persons with a known psychiatric illness, pregnant or using anti-depressant medication will be excluded from the study. Patients will be asked the questions of the online EHP-30 form and the answers given will be evaluated in terms of validation.

Brief summary: For the Turkish validation Study of the Endometriosis Health Profile test (EHP-30) consisting of 30 questions, this 30-question test will be applied to 228 patients after 2 different translations to be applied after the translation of this 30-question test sworn translator to the patients who have been surgically diagnosed with endometriosis.

Detailed description: The appointment of the patients consists of patients who were surgically diagnosed with Endometriosis in our clinic. English and Turkish translation will be verified after 2 different sworn translators.

Eligibility criteria: Inclusion Criteria:

* being surgically diagnosed with endometriosis
* Age between 18- 45
* not being pregnant

Exclusion Criteria:

* have been diagnosed with endometriosis by ultrasound
* above 45 and under 18 years old
* use psichiatrig drugs
* being diagnosed with a psychiatric illness

Primary outcomes:
measure: Turkish Validation of Endometriosis Health Profile -30 (EHP-30) Test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT00595621: Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Official title: Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Stasis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: GI Stimulation, Inc.
name: National Institutes of Health (NIH)
name: American Diabetes Association
First posted: 2008-01-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.

Detailed description: Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI complication in diabetic patients. External gastric pacemaker system will be placed at the same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in diabetic gastroparesis.

Eligibility criteria: Inclusion Criteria:

* Severe nausea and vomiting for at least 6 months
* Documented delayed gastric emptying
* Failed extensive medical treatment

Exclusion Criteria:

* Previous gastric surgery
* Pregnancy or planned pregnancy
* Primary eating or swallowing disorders
* Scheduled or planned MRI testing

Primary outcomes:
measure: Percentage of Slow Wave Entrainment
timeFrame: 12 Weeks
Secondary outcomes:
measure: The Percent (Percentage) of Gastric Retention of a Solid Meal
timeFrame: 12 Weeks
measure: Severity of Gastroparetic Symptoms
timeFrame: 12 weeks
measure: Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))
timeFrame: 12 Weeks
measure: Changes in Hemoglobin A1c (HbA1c) Level
timeFrame: 12 Weeks
measure: Changes in Hospital Admissions
timeFrame: 12 Weeks
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: Richard W. McCallum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02212821: Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2014-08-08
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.


Eligibility criteria: Inclusion Criteria:

* Female only.
* Age \> 18 and \< 60.
* Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5 kg in the past three months).
* Not known to have any chronic medical illness or illnesses affecting the gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric disorder.
* If female not known to be pregnant.
* Not known to have any past upper gastrointestinal surgery.

Exclusion Criteria:

* Alcohol consumption \> 7 drinks / week
* Major depression and chronic health conditions except controlled hypertension

Primary outcomes:
measure: Functional brain images
timeFrame: 40 min after intervention
Secondary outcomes:
measure: hunger scores
timeFrame: every 10 minutes since the scan starts
measure: gut hormones
timeFrame: every 10 min since the scan starts
Other outcomes:
Locations:
Study officials:
affiliation: University of Leuven
name: Jan Tack
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00758121: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
Official title: CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 56
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: Heart failure patients with an implanted CRT-D.

Brief summary: The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.

Detailed description: The purpose of the CORRELATE-HF study is to collect RRT data in heart failure patients to gain a better understanding of how respiratory rate changes in relation to all cause clinical events as well as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.

Eligibility criteria: Inclusion Criteria:

* Implanted COGNIS device or future commercially available Boston Scientific CRT-D, that contains the Sensor Trend for Respiratory Rate, with a right ventricular lead and left ventricular lead actively implanted
* Respiratory Sensor programmed "On"
* Classified as having NYHA Class III heart failure documented, in the past 12 months
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol

Exclusion Criteria:

* Inability or refusal to sign the patient Informed Consent
* Inability or refusal to comply with the follow-up schedule
* Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
* Patients prescribed to positive airway pressure therapy
* A life expectancy of less than 180 days, per physician discretion
* Enrolled in any concurrent study without prior written approval from Boston Scientific CRM
* Women who are pregnant or plan to become pregnant in the next twelve months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: San Diego Cardiac Center
name: Brian Jaski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Pedro Brugada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808621: Muscle Oxygenation in Chronic Obstructive Pulmonary Disease
Official title: Investigation of Peripheral Muscle Oxygenation at Rest and Movement in Hospitalized Patients in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Comparison With Stable Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease Exacerbation
Muscle Oxygenation
Keywords: Chronic Obstructive Pulmonary Disease
Muscle Oxygenation
Chronic Obstructive Pulmonary Disease Exacerbation
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: COPD hospitalized with Severe Acute Exacerbation

Brief summary: The aim of our study is to examine the Peripheral Muscle Oxygenations at rest and in motion on the 2nd day of hospitalized patients and before discharge in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and to compare the results in the hospital periods by repeating the tests in the stable periods of the patients 1 month after discharge.


Eligibility criteria: Inclusion Criteria:

* Being a COPD patient hospitalized with Severe Acute Exacerbation
* be between 40-80 years old
* Having a Body Mass Index below 35

Exclusion Criteria:

* Patients who do not want to participate in the study
* Patients requiring intensive care follow-up during their hospitalization Arthritis, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, broken etc. patients with the condition
* Extensive parenchyma such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with damage
* Patients with severe dyspnea and hemodynamic instability who cannot perform the sit-up test

Primary outcomes:
measure: Muscle oxygenation
timeFrame: 4 weeks
Secondary outcomes:
measure: 1 minute sit and stand test
timeFrame: 4 weeks
measure: Modified Medical Research Council Dyspnea Scale:
timeFrame: 4 weeks
measure: COPD Assessment Test (CAT)
timeFrame: 4 weeks
measure: Charlson Comorbidity Index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
References:
Clinical trial NCT00079521: Therapeutic Touch for Wrist Fractures in Postmenopausal Women
Official title: The Effect of Therapeutic Touch on Bone Formation in Postmenopausal Women After Wrist Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Fractures
Keywords: Bone Metabolism
Therapeutic Touch
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-03-10
Enrollment: 125
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures in women past menopause.

Detailed description: In the United States, the use of complementary and alternative medicine (CAM) increased by approximately 25% between 1990 and 1997. The number of visits to CAM practitioners exceeded visits to primary care physicians by about 250 million in 1997. Energy medicine modalities, including therapeutic touch, healing touch, and reiki, are commonly utilized for conditions ranging from headache to cancer, yet understanding of the human energy field and how it may be used in healing is limited. This study will examine the effect of therapeutic touch on fracture healing in postmenopausal women.

Women will be enrolled in the study within one week of a wrist fracture and will receive either therapeutic touch or a sham (placebo) treatment daily for 3 weeks. Assessments will include blood and urine analysis and measures of pain and function in the affected wrist.

Eligibility criteria: Inclusion Criertia:

* Postmenopausal
* Wrist fracture within 1 week of study entry
* Able to travel to research center for daily treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Karen M. Prestwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00225121: Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors
Official title: A PHASE 1, OPEN-LABEL, DOSE-ESCALATION STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSING SCHEDULES OF PF-00299804 IN PATIENTS WITH ADVANCED MALIGNANT SOLID TUMORS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-23
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Malignant solid tumor for which there is no currently approved treatment
* Adequate bone marrow, liver, cardiac, and kidney function

Exclusion Criteria:

* Cardiac disease
* Anticancer therapy within 4-6 weeks (depending on therapy)
* Pregnant or breast-feeding

Primary outcomes:
measure: Safety
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 6 months
measure: Pharmacodynamics
timeFrame: 6 months
measure: Efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Los Angeles
country: United States
facility: UCLA Oncology Center
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology - Santa Monica
state: California
city: Santa Monica
country: United States
facility: UCLA Santa Monica Hematology/Oncology
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Amsterdam
country: Netherlands
facility: Vereniging het Nederlandse Kanker Instituut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Janne PA, Boss DS, Camidge DR, Britten CD, Engelman JA, Garon EB, Guo F, Wong S, Liang J, Letrent S, Millham R, Taylor I, Eckhardt SG, Schellens JH. Phase I dose-escalation study of the pan-HER inhibitor, PF299804, in patients with advanced malignant solid tumors. Clin Cancer Res. 2011 Mar 1;17(5):1131-9. doi: 10.1158/1078-0432.CCR-10-1220. Epub 2011 Jan 10.