louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004297: Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Status Epilepticus
Keywords: epilepsy
neurologic and psychiatric disorders
rare disease
seizures
status epilepticus
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of California, San Francisco
First posted: 1999-10-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus.

II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission.

III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by center.

Patients en route to the hospital in a San Francisco Department of Health Paramedic Division ambulance are randomly assigned to 1 of 3 treatment groups. Informed consent is waived due to impaired consciousness.

Patients receive intravenous diazepam, lorazepam, or placebo during transport. The patient is re-treated if the seizure is sustained after the first dose or recurs after the first dose without the patient regaining consciousness.

Upon arrival at the hospital, all patients receive the standard status epilepticus treatment in use at that site.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Status epilepticus with at least 5 minutes of sustained seizure activity with a depressed level of consciousness, or 2 or more discrete seizures without recovery or consciousness between seizures Verified by bystander or observed by paramedic from San Francisco Department of Health --Prior/Concurrent Therapy-- No chronic benzodiazepines for seizure disorder --Patient Characteristics-- Cardiovascular: Systolic blood pressure at least 100 mm Hg No second- or third- degree atrioventricular block No sustained ectopic tachyrhythmia Pulse rate between 60 and 150 No severe myocardial insufficiency No hypovolemic, cardiogenic, or obstructive shock Pulmonary: No history of asthma No history of chronic obstructive airway disease No history of limited pulmonary reserve Other: No allergy or prior sensitivity to benzodiazepines No distributive shock (e.g., septic, neurogenic, or anaphylactic)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Daniel Lowenstein
role: STUDY_CHAIR
References:
Clinical trial NCT03947697: Improving Glycemic Control With Electrical Stimulation
Official title: Improving Glycemic Control With Electrical Stimulation in Mexican-Americans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Overweight
Insulin Resistance
Keywords: Obesity
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Once written consent is obtained, the participant will be provided with an accelerometer to be worn for 7 days to assess current physical activity levels. Subjects will be provided with a standardized diet (55/15/30% CHO/PRO/FAT) prior to collection of pre-intervention data of insulin sensitivity. Individuals will then participate in an 8-week electrical stimulation intervention (30min/day, 3x/week) and randomized into placebo/control, NMES, resistance training combined with NMES (RT +NMES), or resistance training (RT) group (n=15 per group), followed by collection of post-intervention data. The control group will receive electrical stimulation up to sensory level, the NMES group will receive stimulation up to tolerable intensity to induce visible muscle contraction, the RT+ NMES will receive stimulation up to tolerable intensity during resistance training, and the RT group will only receive exercise training. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.


Eligibility criteria: Inclusion Criteria:

* Overweight/Obese (BMI ≥25)
* Sedentary Lifestyle: Physical Activity Level\<1.4
* Less than 150min/week of structured Exercise

Exclusion Criteria:

* Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications
* Excessive alcohol, drug abuse, smoking
* Pregnant Women
* Unwilling to adhere to the study Intervention

Primary outcomes:
measure: Glycemic Control
timeFrame: 8 weeks
Secondary outcomes:
measure: Respiratory Exchange Ratio
timeFrame: 8 Weeks
measure: Amount of lean mass
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University of Texas at El Paso
state: Texas
Study officials:
References:
Clinical trial NCT01061697: Pregabalin and Radicular Pain Study (PARPS)
Official title: Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS))
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Spondylosis
Cervical Spondylotic Myelopathy
Cervical Spondylotic Radiculopathy
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-02-03
Enrollment: 50
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: This study is designed to investigate the effectiveness of pregabalin (Lyrica) on nerve pain caused by degenerative neck problems. Pregabalin is a new drug registered for use in nerve pain worldwide

Detailed description: The treatment of neuropathic pain is clinically challenging, and pain from cervical spondylosis (CS) is a common variant. This may result from degenerative spinal canal/cord stenosis (cervical spondylotic myelopathy (CSM)) or lateral recesses compromise, leading to nerve root compression (cervical spondylotic radiculopathy (CSR)).

Pregabalin is a newly registered drug for the treatment of neuropathic pain. Its efficacy has been proven in randomised, placebo-controlled trials for post-herpetic neuralgia and diabetic neuropathy. However, its efficacy in CS with underlying CSR or CSM has not been established. Additionally, there are no data to date on its use in Asian patients.

In this study, we prospectively evaluate its efficacy for treating neuropathic pain in degenerative CSR/ CSM 60 patients in an open-labelled, add on fashion. Self-evaluation and investigator rated scoring will be implemented.

The results will be of value in the non-operative management of CS.

Eligibility criteria: Inclusion Criteria:

* Clinical \& MRI, or electrophysiological evidence of pain due to radiculopathy
* Patients with CS and CSR or CSM with neuropathic pain due to the above in the neck and upper limbs or lower limbs (including dysesthesia, paresthesia, hyperalgesia).

Exclusion Criteria:

* Diabetic neuropathy or other underlying neuropathic conditions
* Contraindications and allergy to pregabalin
* Previously treated with gabapentin in the last 8 weeks
* Pregnant or breast feeding
* History of renal impairment
* History of other causes of neuropathic pain

Primary outcomes:
measure: Visual Analogue Scale (VAS): Pain ruler done daily
timeFrame: 2 months
Secondary outcomes:
measure: Short-Form McGill Pain Questionnaire (SFMPQ)
timeFrame: 0, 1, 2 months
measure: Patient and Clinical Global Impression of change
timeFrame: 0, 1, 2 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
state: Outram Road
Study officials:
affiliation: National Neuroscience Institute, Singapore General Hospital
name: Y L Lo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05234697: Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids
Official title: Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Hyperalgesia
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were included.

Brief summary: To explore the effect of daytime variation on postoperative hyperalgesia induced by opioids. Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were respectively included. Postoperative hyperalgesia at PACU and 24 hours after surgery were assessed through mechanical pain measurement. Comparative analysis of postoperative hyperalgesia levels, pain and analgesic requirements between morning group and afternoon group were performed.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classification I-II
* Abdominal endoscopy surgery
* Estimated surgery duration 1-2h
* Right handedness
* Voluntarily receive postoperative intravenous controlled analgesia

Exclusion Criteria:

* Heavy smoking or alcohol dependence
* Puerpera or lactation women
* History of chronic pain
* Analgesic use within one month before surgery
* Allergy to opioids
* Can not follow with the study procedure

Primary outcomes:
measure: Postoperative hyperalgesia when discharged from postanesthesia care unit
timeFrame: from the 30 minutes before the surgery until to the time when discharged from postanesthesia care unit, assessed up to about 2 hours
Secondary outcomes:
measure: Postoperative hyperalgesia at 24 hours after surgery
timeFrame: from the 30 minutes before the surgery until to 24 hours after surgery
measure: Postoperative pain intensity
timeFrame: from the time when the surgery was completed until to 24 hours after surgery
measure: Postoperative analgesic requirements
timeFrame: from the time when the surgery was completed until to 24 hours after surgery
measure: Plasma concentration of remifentanil and sufentanil
timeFrame: from 30 minutes before the surgery until to the time after stop infusion of remifentanil, assessed up to about 2 hours
measure: Activity of plasma nonspecific esterase
timeFrame: from 30 minutes before the surgery until to the time after stop infusion of remifentanil, , assessed up to about 2 hours
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT05702697: The Efficacy of Focus Extracorporeal Shock Wave Therapy on Hamstring Tightness
Official title: The Efficacy of Focus Extracorporeal Shock Wave Therapy on Hamstring Tightness in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hamstring Tightness
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study efficacy of focus extracorporeal shock wave therapy on the flexibility of hamstring muscles in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Limited hamstring flexibility; passive knee extension degree \>20
* No underlying disease

Exclusion Criteria:

* Patients with history of physical therapy in past 3 month
* Patient with analgesic drug such as muscle relaxant or NSAID.
* Patient with limited hamstring flexibility due to neurological or musculoskeletal diseases.
* Patient with cardiac pacemaker, pregnancy, hypercoagulable conditions, severe osteoporosis, malignancy or active infection around intervention site.
* Patient with history of chronic knee or back pain
* Patient cannot follow home stretching exercise program

Primary outcomes:
measure: Passive knee extension test
timeFrame: Immediately after every F-ESWT treatment, for 3sessions
Secondary outcomes:
measure: Back-saver sit-and-reach test (BSSR)
timeFrame: Immediately after every F-ESWT treatment, for 3sessions
measure: Sit and reach test (SRT)
timeFrame: Immediately after every F-ESWT treatment, for 3sessions
measure: Toe touch test (TT)
timeFrame: Immediately after every F-ESWT treatment, for 3sessions
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Physical medicine and rehabilitation
Study officials:
affiliation: Mahidol University, Ramathibodi Hospital
name: Songsuda Roongsaiwatana, M.D.
role: STUDY_DIRECTOR
References:
citation: Kim YW, Chang WH, Kim NY, Kwon JB, Lee SC. Effect of Extracorporeal Shock Wave Therapy on Hamstring Tightness in Healthy Subjects: A Pilot Study. Yonsei Med J. 2017 May;58(3):644-649. doi: 10.3349/ymj.2017.58.3.644.
Clinical trial NCT06312397: The Effect on Back Pain and Fatigue Level of Acupressure
Official title: The Effect on Back Pain and Fatigue Level of Acupressure After Coronary Angiography: A Randomized, Single-Blind Sham-Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Angiography
Keywords: Coronary angiography
Acupressure
Low back pain
Fatigue, Muscle
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups ( acupressure group, sham acupressure group and control group)
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography.

Detailed description: To prevent bleeding, hematoma, and embolism after coronary angiography, patients are asked to stay in bed for 6 to 24 hours. During complete bed rest for at least 6 hours, the patient should keep his/her feet flat. The patient should lie in the supine position and avoid rapid movements. Long-term bed rest (at least 6 hours) in post-angiographic patients causes weakening of the lower back muscles and fatigue due to the pressure constantly applied to the same muscles, while muscle fatigue causes muscle spasms and lower back pain. Today, acupressure is also used along with various pharmacological treatments to relieve pain and fatigue.

Acupressure is a massage technique that ensures the proper functioning of energy channels by applying some pressure to certain parts of the body with the thumbs or index fingers, hands, palms, wrists and knees for therapeutic purposes. Acupressure points are the same as acupuncture points. Although there is no needle inserted into the body as in acupuncture.

According to G-power analysis, the total number of samples was calculated as 120.

A total of 120 participants will be randomly assigned to the acupuncture group (n=40), sham acupuncture group (n=40) and control group (n=40).

A Personal Information Form and Visual Analog Scales for Pain and Fatigue will be used to collect data.

Eligibility criteria: Inclusion Criteria:

* Planned coronary angiography from the femoral region
* Not diagnosed with low back pain
* No stent or other interventional procedure was performed during the coronary angiography procedure.

Exclusion Criteria:

* Those who have had acupressure before for any purpose
* Problems such as bleeding and dysrhythmia occur after coronary angiography,
* Those with burns, scars, scratches and deformities at the acupressure point
* Having any psychological disorder,

Primary outcomes:
measure: Visual Analog Scale for Pain
timeFrame: 1 year
measure: Visual Analog Scale for Fatigue
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Birgül VURAL DOĞRU
Study officials:
References:
Clinical trial NCT04253197: Ultrasound Staging in the Placenta Accreta
Official title: Efficacy of Ultrasound Staging System in Prediction of Morbidly Adherent Placenta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Labor Complications
Staging of Placental Invasion
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pregnant women in 3rd trimester
Primary purpose: DIAGNOSTIC

Brief summary: The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.

Detailed description: Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta accreta, increta, and percreta, which are associated with significant maternal and fetal morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta include the loss of myometrial interface or retroplacental clear space, reduced myometrial thickness and the presence of intraplacental lacunae. Using a staging system by antenatal ultrasound can predict placental invasion antenatally.

Eligibility criteria: Inclusion Criteria:

* Prior lower segment cesarean section
* Low lying anterior placenta
* Singleton pregnancy

Exclusion Criteria:

* Medical disorders
* vasa previa

Primary outcomes:
measure: Confirmation of the stage of myometrial placental invasion
timeFrame: 1 hour
Secondary outcomes:
measure: Blood loss
timeFrame: 1 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Beni-Suef University
Study officials:
References:
citation: Albayrak M, Ozdemir I, Koc O, Demiraran Y. Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):377-80. doi: 10.1111/j.1479-828X.2011.01309.x. Epub 2011 Apr 18.
citation: American institute of ultrasound in medicine 2015.
Clinical trial NCT00297297: Improved Preoperative Selection of Cold Thyroid Nodules
Official title: Preoperative Selection of Solitary Solid Cold Thyroid Nodules - A Prospective Study on the Value of Sonography, Cytology, Immunostaining and Molecular Profiling
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Nodules
Keywords: Solitary solid and scintigraphically cold thyroid nodules
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2006-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary referral center (Endocrine outpatient - University Hosiptal - clinic). Patients referred with a solitary thyroid nodule

Brief summary: Molecular gene profiling of fine-needle aspiration samples in addition to fine-needle aspiration cytology can improve the selection of patients with benign versus malignant thyroid nodules with improved sensitivity.


Eligibility criteria: Inclusion Criteria:

* Solitary thyroid nodules that appear solid on ultrasound and cold on a scintiscan

Exclusion Criteria:

* Pregnancy and lactation
* Age below 20 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Outpatient clinic of The Department of Endocrinology, Herlev University Hospital
Study officials:
affiliation: Department of Endocrinology and Metabolism, Herlev University Hospital, DK-2730 Herlev, Denmark
name: Finn N Bennedbaek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finley DJ, Zhu B, Barden CB, Fahey TJ 3rd. Discrimination of benign and malignant thyroid nodules by molecular profiling. Ann Surg. 2004 Sep;240(3):425-36; discussion 436-7. doi: 10.1097/01.sla.0000137128.64978.bc.