louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00879450: Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Official title: Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Torticollis
Keywords: Congenital muscular torticollis
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2009-04-10
Enrollment: 160
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with a torticollis are usually referred for physiotherapy where they are evaluated, and given exercises as well as education to treat the condition. This study is being done in order to compare 2 methods of sharing information with parents of children with torticollis.

Detailed description: 160 children of less than 6 months of age will be recruited for the study and divided in 2 groups. Children of both groups will receive the same physiotherapy evaluation and exercises but parents will receive information handouts with one of two different types of illustrations and written instructions for home exercises.

Eligibility criteria: Inclusion Criteria:

* Aged newborn to 6 months at initial visit in physiotherapy,
* A diagnosis of PT made by a physician,
* At least 37 weeks of gestational age at delivery

Exclusion Criteria:

* Congenital muscular torticollis with fibrosis (confirmed diagnosis): because this is a rare condition that has a different rate of recovery,
* Presence of craniosynostosis (confirmed diagnosis made by a neurosurgeon),
* APGAR score of less than 7 at 5 minutes,
* Prescription of a Tubular Orthosis for Torticollis (TOT) collar or Botox intervention for the torticollis,
* Confirmed diagnosis of syndrome or neurological condition.

Primary outcomes:
measure: Neck range of motion measurements
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital, MUHC
state: Quebec
Study officials:
References:
Clinical trial NCT00674050: A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers
Official title: A Phase 1, Open-Label Study to Investigate the Effect of Albuterol (Salbutamol) and Fluticasone on the Pharmacokinetics of Inhaled Technosphere® Insulin Inhalation Powder in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Healthy Subjects
Keywords: Healthy Males or Females subjects
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of inhaled albuterol \& fluticasone on one dose of TI Inhalation Powder. A total of 12 eligible subjects will be enrolled.


Eligibility criteria: Inclusion Criteria:

Subjects must have a fasting blood glucose (BG) level of less than 6.1 mmol/L FEV1/ FVC = LLN TLC = 80% Predicted DLco (unc) = 80% Predicted (Miller) No significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of = 12% and = 200 mL in FEV1 or FVC) at Screening FEV1 = 80% (NHANES III Predicted

Exclusion Criteria:

History of diabetes mellitus Previous exposure to any inhaled insulin product Any known pulmonary disease or inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria Respiratory tract infection within 8 weeks prior to Screening/Visit 1 Major organ system diseases including seizures, heart failure, uncontrolled hypertension, aneurysm, cancer within the past 5 years, liver disease, anemia or autoimmune disorder Clinically significant abnormalities on screening laboratory evaluation Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control Unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions

Primary outcomes:
measure: PK parameters of serum insulin
timeFrame: 0-360 min
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester, United Kingdom
country: United Kingdom
facility: ICON Development Solutions
Study officials:
affiliation: Mannkind Corporation
name: Anders H. Boss
role: STUDY_CHAIR
References:
Clinical trial NCT00065650: Pilot Study of Vedic Medicine for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus Type 2
Vedic medicine
Ayurveda
Transcendental Meditation
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility and effectiveness of a multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2 diabetes.

Detailed description: Maharishi Vedic Medicine (MVM) represents a synthesis of Vedic sciences, including Ayur-Veda, into a single, comprehensive, natural approach to health care. The objectives of this phase II pilot trial are to determine the feasibility, acceptability, and safety of implementing a multi-modality MVM intervention for newly diagnosed type 2 diabetics, and to measure the impact of such a protocol on overall glycemic control.

Eligibility criteria: Inclusion criteria:

* Kaiser Permanente members
* Newly diagnosed type 2 Diabetes
* Baseline glycosylated hemoglobin level of 6.0-7.9.

Exclusion criteria:

* Pregnancy or nursing mother
* Currently taking warfarin
* Diagnosis of psychotic disorder or recent hospitalization for depression
* Unable to comply with or attend treatment sessions

Primary outcomes:
measure: HbA1C
timeFrame: 3 months
Secondary outcomes:
measure: Fasting Glucose
timeFrame: 3 and 6 months
measure: Lipids
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
References:
citation: Elder C. Application of the cooperative health care clinic model for the delivery of complementary/ alternative care. The Permanente Journal. Winter 2003; 7(1):55-60.
citation: Elder C. Complementary and Alternative Medicine Symposium: Integrating CAM into clinical practice: The KP northwest story. The Permanente Journal, Fall 2002, 6(4):57-59
citation: Elder C, Aickin M, Bauer V, Cairns J, Vuckovic N. Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Altern Ther Health Med. 2006 Sep-Oct;12(5):24-30.
Clinical trial NCT03068650: Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut
Official title: Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Recurrent GBM
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-03-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in patients with EGFRvlll expressing recurrent glioblastoma will be considered.


Eligibility criteria: Inclusion Criteria:

* The patient has histologically confirmed relapsed or recurrent GBM.
* EGFRvIII expression in tumor tissue, as assessed by a central laboratory using the Celldex assay.
* Prior or planned therapy must include standard chemoradiation with temozolomide, unless the patient is not a candidate.
* Systemic corticosteroid therapy tapered to less than 4 mg of dexamethasone (or equivalent) per day.
* The patient does not have a known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
* The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive rindopepimut vaccine therapy.
* The patient is surgically sterile or post-menopausal, or, if of child-bearing potential, had a negative serum pregnancy test within the week prior to initiation of rindopepimut and is not nursing.
* Males and females of childbearing potential must agree to practice an effective form of contraception during the time from signing of informed consent through 28 days after the last dose of rindopepimut.
* The patient is able to read and understand, and has signed a patient informed consent form, which outlines the anticipated benefits and risks of treatment with rindopepimut.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02747550: Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy
Official title: Temporary Simultaneous Two-arterial Occlusions to Reduce Operative Blood Loss During Laparoscopic Myomectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myoma
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.

Detailed description: Significant hemorrhage is major perioperative concern in myomectomy, and can result in need of blood transfusion, conversion to hysterectomy, development of hypovolemic shock and postoperative anemia, and delayed recovery. Therefore, methods to decrease operative blood loss during myomectomy in women wishing to preserve their uterus and fertility are important and must be developed.

Eligibility criteria: Inclusion Criteria:

* women with symptomatic myomas such as menorrhagia, pelvic pressure/pain, or infertility
* women who were planning to undergo laparoscopic myomectomy
* women who had ≤ 10 myomas, with the largest myoma ≤ 10 cm
* women with regular menstrual bleeding
* women who were not pregnant at the surgery
* women between 19 and 48 years of age.

Exclusion Criteria:

* women who underwent concomitant complex surgical procedures at the time of laparoscopic myomectomy, such as severe adhesiolysis or resection for severe endometriosis
* women who were in postmenopausal or climacteric status
* women with a history of oophorectomy or salpingo-oophorectomy
* women with any suggestion of malignant uterine or adnexal diseases
* women with major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
* women who refused to participate or give consent to the procedures

Primary outcomes:
measure: operative blood loss
timeFrame: the day of surgery
Secondary outcomes:
measure: change in hemoglobin
timeFrame: post-operative day 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Taejong Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06087250: Carotid Artery Corrected Flow Time and Fluid Responsiveness in Geriatric Patients
Official title: Reliability of Carotid Artery Corrected Flow Time Predicting Fluid Responsiveness in Geriatric Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Common Carotid Artery
Keywords: fluid responsiveness
carotid blood flow
carotid corrected flow time
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: geriatric patient (older than 65 years of age) having surgery under general anesthesia

Brief summary: Carotid blood flow and corrected carotid flow time (Carotid Flow Time (FTc)) provide information about left ventricular preload and inversely correlate with systemic vascular resistance. The reliability in assessing fluid responsiveness has been demonstrated in studies involving invasive cardiac output measurements. In the elderly patient population where arterial elasticity can be compromised, there is no existing data in literature that determines the reliability and predictive value of FTc after general anesthesia induction.

Detailed description: Doppler ultrasound of the common carotid artery has begun to be used as a potential non-invasive tool for assessing hemodynamic status. Its non-invasive nature, ability to be applied independently of the patient's position, ease of application due to the superficial location of the carotid artery, and resistance to intrathoracic pressure changes are among its advantages. Carotid blood flow and corrected carotid flow time (Carotid Flow Time (FTc)) provide information about left ventricular preload and inversely correlate with systemic vascular resistance. Additionally, the velocity time integral (VTI) measuring blood flow through the carotid artery during systole, when multiplied by the cross-sectional area of the carotid artery, allows for the determination of flow within the carotid artery. The reliability in assessing fluid responsiveness has been demonstrated in studies involving invasive cardiac output measurements. In the elderly patient population where arterial elasticity can be compromised, there is no existing data in literature that determines the reliability and predictive value of FTc after general anesthesia induction.

Eligibility criteria: Inclusion Criteria:

* geriatric patient (older than 65 years of age) having surgery under general anesthesia

Exclusion Criteria:

* Common carotid artery stenosis, common carotid artery disease

Primary outcomes:
measure: carotid corrected flow time (cFT)
timeFrame: 1 hour
Secondary outcomes:
measure: cutt-of value of cFT
timeFrame: 1 hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Hospital
Study officials:
References:
Clinical trial NCT05478850: Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia
Official title: An Observational Cohort Study of Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia; Anesthesia
Hyperthermia, Anesthesia Related
Radiotherapy Side Effect
Childhood Cancer
Keywords: Hypothermia; Anesthesia
Hyperthermia, Anesthesia Related
Radiotherapy Side Effect
Childhood Cancer
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 152
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing radiotherapy under anesthesia

Brief summary: In prospective, observational cohort study, changes in body temperature will be investigated before the procedure and during recovery in Radiotherapy patients aged 0-18 years who need sedation due to childhood malignancies.

The aims of this study were to measure the incidence and magnitude of changes in body temperature in children undergoing sedation or general anesthesia for Radiotherapy, and to determine their effects on the recovery process.


Eligibility criteria: Inclusion Criteria:

* patients undergoing radiotherapy under anesthesia

Exclusion Criteria:

* family refusal to participate,
* chronic nausea and vomiting complaints,
* active infection,
* apnea history,
* cardiac disease, kidney and liver failure,
* anomalies that may cause difficult airway,
* metabolic diseases,
* neurological or muscular diseases.

Primary outcomes:
measure: body temperature change among 2 time period
timeFrame: time from before radiotherapy to the end of radiotherapy
measure: recovery time from anesthesia
timeFrame: the time from end of radiotherapy to discharging
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Betül Güven Aytaç, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004650: Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: disease-related problem/condition
osteoporosis
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Washington University School of Medicine
First posted: 2000-02-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women.

II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients.

III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are randomly assigned to receive placebo or conjugated estrogens and, if no prior hysterectomy, medroxyprogesterone. Patients also receive calcium supplementation therapy daily for 3 years.

Participants in the placebo group may be removed from study if bone loss exceeds 5% per year.

A study duration of 3 years is anticipated.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Women postmenopausal for at least 2 years
* At least 10 teeth for which radiographic measurements can be obtained, i.e.: Not severely tilted Not so closely spaced that interproximal bone is thin Not in positions of restricted access

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Charles F. Hildebolt
role: STUDY_CHAIR
References:
citation: Hildebolt CF, Pilgram TK, Dotson M, Yokoyama-Crothers N, Muckerman J, Hauser J, Cohen S, Kardaris E, Vannier MW, Hanes P, Shrout MK, Civitelli R. Attachment loss with postmenopausal age and smoking. J Periodontal Res. 1997 Oct;32(7):619-25. doi: 10.1111/j.1600-0765.1997.tb00940.x.
citation: Hildebolt CF. Osteoporosis and oral bone loss. Dentomaxillofac Radiol. 1997 Jan;26(1):3-15. doi: 10.1038/sj.dmfr.4600226.
citation: Hildebolt CF, Brunsden B, Yokoyama-Crothers N, Pilgram TK, Townsend KE, Vannier MW, Shrout MK. Comparison of reliability of manual and computer-intensive methods for radiodensity measures of alveolar bone loss. Dentomaxillofac Radiol. 1998 Jul;27(4):245-50. doi: 10.1038/sj/dmfr/4600352.
Clinical trial NCT01805050: Case Study: HAGL-lesion (HAGL:Humeral Avulsion Glenohumeral Ligament)
Official title: Arthroscopically Repair of the Anterior Instability of the Shoulder Due an HAGL - Lesion - A Case Serie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Injuries and Disorders
Keywords: HAGL
Shoulder instability
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent surgical repair of the anterior instability due an HAGL lesion at the Schulthess Klinik and have been performed surgery by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey

Brief summary: This study shows a new technique which has been implemented at the schulthess clinic to improve the outcome after an correction of an anterior instability in the shoulder joint due to a HAGL lesion.

Detailed description: The aim of the study is to describe and document the results of a case serie after an arthroscopically intervention to correct the anterior instability in the shoulder joint with one primary parameter (WOSI-Score) and several secondary parameters, which are used in the daily clinical routine (e.g.clinical examination, several questionnaires). The results of these parameters will be used to document the mid-term results (\> 1 year after surgery).

Eligibility criteria: Inclusion Criteria:

* arthroscopically repair of the anterior instability of the shoulder due an HAGL lesion (performed by Dr. M. Flury, Dr. H.-K. Schwyzer or Dr. Ph. Frey at the Schulthess Klinik)
* patients ≥18 years
* written informed consent

Exclusion Criteria:

* additional surgeries at the affected side after the index surgery (arthroscopically repair of the anterior instability due an HAGL lesion)
* non-compliance
* disorders which handicap or inhibit the patient to follow the orders of the clinical testers
* request of the patient

Primary outcomes:
measure: WOSI-Score
timeFrame: expected average of 2 years
Secondary outcomes:
measure: Sociodemographic Dates
timeFrame: expected average of 2 years
measure: x-ray images
timeFrame: expected average of 2 years
measure: Constant-Murley Score
timeFrame: expected average of 2 years
measure: Rowe - Score
timeFrame: expected average of 2 years
measure: SSV (Simple Shoulder Value)
timeFrame: expected average of 2 years
measure: SST (Simple Shoulder Test)
timeFrame: expected average of 2 years
measure: Measurement of the abduction strength
timeFrame: expected average of 2 years
measure: Measurement of the external rotation strength
timeFrame: expected average of 2 years
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
state: Canton of Zürich
Study officials:
affiliation: Upper Extremities Department
name: Matthias Flury, Dr
role: PRINCIPAL_INVESTIGATOR
References: