louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01353040: Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg Virus
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-6003 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Marburg Hemorrhagic Fever
Lead sponsor: Sarepta Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2011-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6003, a post-exposure prophylaxis candidate treatment for Marburg virus.

Detailed description: Marburg hemorrhagic fever is a rare human disease caused by the Marburg virus, a filamentous, single-stranded, negative-sense RNA virus. In general, the mortality rate associated with Marburg virus outbreaks has ranged from 23% to 88%, with the highest death rates seen in more recent epidemics. No vaccine or effective therapy is available for Marburg hemorrhagic fever. AVI-6003 is an experimental combination of 2 phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). These oligomers specifically target viral messenger RNA encoding 2 Marburg virus proteins thought to be important in viral replication and host immune suppression. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-6003 in healthy human subjects.

Eligibility criteria: Inclusion Criteria:

* Male or female and between the ages of 18 and 50 years in good general health
* Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
* Volunteers must be willing to undergo a urine screen for drugs of abuse

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
* Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection

Primary outcomes:
measure: Number of subjects experiencing adverse events
timeFrame: 28 days
Secondary outcomes:
measure: Plasma drug concentration
timeFrame: 28 days
measure: Urine drug concentration
timeFrame: 28 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials
state: California
Study officials:
affiliation: Sarepta Therapeutics, Inc.
name: Alison Heald, MD
role: STUDY_DIRECTOR
affiliation: West Coast Clinical Trials
name: Apinya B Vutikullird, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00999440: QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
Official title: QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Methadone
Perceived Sleep
QTc
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: QTc:

Since the reports of three deaths attributed to Torsade de Point (TdP) related to treatment with the long-acting methadone derivative levomethadyl acetate HCl (LAAM), methadone has been scrutinized for any possible association with TdP. Since then, several studies among Methadone Maintenance Treatment (MMT) patients and chronic pain patients were done, reporting diverse results about possible association between methadone dose and QTc prolongation. Most studies however were cross-sectional and generally found insignificant clinical prolongation of QTc. A follow up studies are of importance, and although few studies have started evaluating QTc among MMT patients, none was done among chronic pain patients with no history of drug usage. One study of 8 chronic pain patients experiencing insufficient pain control or intolerable side effects during treatment with oral morphine switched to oral methadone showed insignificant modest increase QTc following 9 month.

Perceived Sleep:

Chronic pain patients as well as drug addicts are known to suffer from poor sleep. Some studies found possible relation to methadone dose, however, no causal association was found and importantly some also found association with duration of opiate usage before starting methadone when entry to MMT clinic. Thus, patients with no history of opiate addiction are an important interesting group that may help understand relation between methadone usage and sleep quality. However, sleep must be evaluate before opiate administration and a follow up study is needed


Eligibility criteria: Inclusion Criteria:

* adults (18+ years) patients with chronic pain, who intend to be medicated with any opiates

Exclusion Criteria:

* patient with no opiate usage through last year

Primary outcomes:
measure: To evaluate the influence of opioid drugs on QTc interval before and during Opioid treatment among patients suffering from chronic pain.
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the perceived sleep in the chronic pain patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, Pain Medicine Unit
Study officials:
References:
Clinical trial NCT05485740: Cognitive Multisensory on Upper Extremity in Stroke
Official title: Cognitive Multisensory Rehabilitation on Upper Extremity Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the control group which received the selected exercise program and the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program
Primary purpose: TREATMENT

Brief summary: PURPOSE:

To investigate the effect of cognitive multisensory rehabilitation program on upper extremity function in stroke patients.

BACKGROUND: Cognitive Multisensory Rehabilitation (CMR) is a promising therapy for upper limb recovery in stroke, as the CMR considered an effective therapy for motor recovery for adults with stroke

Detailed description: Thirty patients with stroke The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program, three times per week for 2 months. The evaluation methods Action research arm test (ARAT), Fugl-Myer Assessment upper extremity (FMA-UE), manual function test and Motor Evaluation Scale for Upper Extremity

Eligibility criteria: Inclusion Criteria:

1. Thirty hemiplegic patients, with the onset of stroke six months or longer.
2. Both sexes, with ages ranging from 45: 60.
3. Body mass index will range from 18.5-to 29.9 Kg/m2.

Exclusion Criteria:

1. Other brain injuries/illnesses, cognitive impairment, severe sensory or proprioceptive loss.
2. Other causes of hemiplegia.
3. Other causes of upper extremity dysfunction.

Primary outcomes:
measure: Action research arm test
timeFrame: 8 weeks
measure: Manual function test
timeFrame: 8 weeks
measure: Fugl Myer Assessment upper extremity
timeFrame: 8 weeks
measure: Motor Evaluation Scale for Upper Extremity in Stroke patients
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama S Mahmoud
state: Select State
Study officials:
References:
Clinical trial NCT01373840: Role of Dopamine Receptors in Primary Focal Dystonias
Official title: Role of Dopamine Receptors in Primary Focal Dystonias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Focal Dystonias
Keywords: focal
dystonia
dopamine
receptor
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2011-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any healthy control or patient with primary focal dystonia or arm or face.

Brief summary: Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather rudimentary. A better understanding of neural mechanisms of dystonias is not only an invaluable prerequisite for developing better treatment options but also a step toward better understanding of the complex network of basal ganglia. In this study I will investigate if there is any difference between the dopamine receptors and dopamine in people with dystonia and healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Age \>20
* Male or Female
* Any race or ethnicity
* Primary focal dystonia (arm or cranial)
* Ability to give informed consent

Exclusion criteria:

* Family history of dystonia
* Pregnancy (confirmed with negative urine pregnancy test in women of child bearing potential), breastfeeding
* Exposure to radiation therapy
* Any MRI contraindications such as foreign metallic implants, pacemaker, and aneurysm clip etc.
* History of cardiac disease, uncontrolled hypertension, abnormal EKG during screening phase
* History of exposure to any drugs affecting dopaminergic systems within the last 6 months (e.g. dopamine receptor blocking agents, cocaine, amphetamine, tetrabenazine, reserpine, L-dopa, dopamine agonists, as they might affect the dopamine receptor binding or endogenous dopamine).
* Active depression (Beck Depression Inventory_II \>14)
* Cognitive impairment (Mini-Mental State Score \<27)
* CNS active medications such as gabapentin or narcotics, muscle relaxants which might be given for pain in the 3 days prior to study
* History of stroke, seizure, cerebral palsy, generalized dystonia, parkinsonism, inability to hold head still during the scanning time.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Perlmutter Joel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04629040: The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed
Official title: The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators would let knee osteoarthritis patient dressing lateral wedge insole and evaluate the effect for foot pressure modification, quadriceps thickness detected with ultrasound and gait. Investigators would made the patient in control group dressing ordinary insole.

Detailed description: Knee osteoarthritis is one of the most popular disease affected elderly people and made them discomfort. There was no study using foot pressure as a parameter about lateral wedge insole intervention for the knee osteoarthritis patient. The purpose of this study was to investigate the effect of lateral wedge insole for the patient of knee osteoarthritis. During total period of 12 weeks for the study, investigators randomized the patient into experimental and control group. Then investigators evaluated the patient's foot pressure, quadriceps thickness, stride length, stride width, walking speed, pain scale and daily function before intervention, 4th weeks, 8th weeks and 12th weeks. Investigators would use pressure insole designed in the Industrial Technology Research Institute in Taiwan. The portable device used in this study maybe suitable for evaluation of other lower limb disease. There were studies evaluating elderly people dysfunction, critical illness muscle atrophy or knee joint disease with ultrasound detected quadriceps thickness. But there was no study about the correlation between foot pressure and quadriceps thickness for evaluating the effect of lateral wedge insole. Investigators hoped to make a new model for evaluating lower limbs disorder in the future.

Eligibility criteria: Inclusion Criteria:

* Knee osteoarthritis patients
* Medial knee pain

Exclusion Criteria:

* Unable to walk independently
* Ambulation with device
* Any neurologic disease
* Rheumatoid arthritis, gouty arthritis
* History of lower limbs fracture
* History of operation for lower limbs
* Any infectious disease

Primary outcomes:
measure: Change from baseline in foot pressure at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in quadriceps thickness at week 4, week 8 and week 12
timeFrame: Baseline, week 4, week 8 and week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia University Hospital
Study officials:
References:
Clinical trial NCT01978340: Eval EarlySense Bet Lowenstein Sleeplab
Official title: Evaluation of EarlySense - a Contact-less Heart and Respiration Rate Monitor in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obese
Sleep Apnea, Obstructive
Central Apnea
Sleep Disorders
Poor Quality Sleep
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Different patient population will be monitored including obese, morbidly obese, patients with or without apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Brief summary: The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Detailed description: EarlySense sensors will be placed under the mattress of subjects who have been included in the study. The sensors will not be in any contact with the patient. Two sensors will be utilized and placed under the subject's chest and pelvis area. Accuracy of the sensors will be compared to each other and to the reference device.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or above
2. Is willing to sign the consent form

Exclusion Criteria:

1. Age \< 18 years
2. Is not willing to sign the consent form

Primary outcomes:
measure: To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab
timeFrame: up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Raa'nana
country: Israel
facility: Beit Lowenstien
Study officials:
affiliation: Beit Lowenstein Hospital
name: Tatiana Vander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04785040: The Turkish Version of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM-T)
Official title: The Turkish Version of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM-T): A Validity, Reliability and Cross-cultural Adaptation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Pain
Questionnaire
Keywords: musician
orchestra musicians
Musculoskeletal Pain
questionnaire
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: professional orchestra musician

Brief summary: The aim of this study, original named "The musculoskeletal pain intensity and interference questionnaire (MPIIQM)" is the Turkish validation, reliability and cross-cultural validation of the questionnaire.


Eligibility criteria: Inclusion Criteria:

* permanent musician in an orchestra
* understand and reading Turkish

Exclusion Criteria:

* freelance musician

Primary outcomes:
measure: The Musculoskeletal Pain Intensity and Interference Questionnaire for Professional Orchestra Musicians
timeFrame: Baseline
measure: The Musculoskeletal Pain Intensity and Interference Questionnaire for Professional Orchestra Musicians
timeFrame: 5 days after
Secondary outcomes:
measure: Brief Pain Inventory
timeFrame: Baseline
measure: The QuickDASH
timeFrame: Baseline
measure: The Fatigue Severity Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
Study officials:
References:
Clinical trial NCT03586440: Effect of Forward Head and Rounded Shoulder Posture on Hand Grip Strength in Asymptomatic Young Adults
Official title: Effect of Forward Head and Rounded Shoulder Posture on Hand Grip Strength in Asymptomatic Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Weakness
Keywords: RS-FHRSP-grip strength
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asymptomatic young adults students

1. forward head rounded shoulder posture group
2. rounded shoulder posture group
3. normal posture group

Brief summary: * see if there is significant difference between subjects with forward head rounded shoulder posture and subjects with normal posture in hand grip strength in asymptomatic young adults
* see if there is significant difference between subjects with rounded shoulder posture and subjects with normal posture in hand grip strength in asymptomatic young adults

Detailed description: * in forward head posture there is flexion in lower cervical vertebrae that causes tension on lower cervical nerve roots according to Harrison systemic review and these lower cervical nerve roots supply hand muscles
* also in rounded shoulder posture there is weakness in scapular stabilizers and retractors which affect proximal stability of the arm
* proximal stability is important for distal mobility
* so from this biomechanical point of veiw we conduct this study to see if forward head and rounded shoulder posture can affect hand grip strength in asymptomatic young adults.

Eligibility criteria: Inclusion Criteria:

66 subjects from both genders sedentary life.

* 22 subjects with rounded shoulder posture with the distance between on the table and the posterior aspect of lateral part of acromion process ≥ 2.5 cm
* 22 subjects with forward head rounded shoulder posture with craniovertebral angle ≤ 50 and the distance between on the table and the posterior aspect of lateral part of acromion process ≥ 2.5 cm
* 22 subjects with normal posture
* asymptomatic participants
* age range from 19-24 years old
* normal body mass index
* right handed subjects

Exclusion Criteria:

* • Neck or shoulder symptoms

  * Shoulder fracture
  * Shoulder dislocation
  * radiculopathy
  * Recent shoulder surgery
  * athletes
  * musculoskeletal abnormalities

Primary outcomes:
measure: hand grip strength
timeFrame: 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy-Cairo University
Study officials:
affiliation: Cairo University
name: dalia M mosaad, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06891040: Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 in Adult Subjects With Mild to Moderate Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-blind, Vehicle Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 in Adult Subjects With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 114
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: A multicenter, randomized, double-blind, vehicle controlled phase II clinical study


Eligibility criteria: Inclusion Criteria:

1. Subjects fully understand this study, are able to follow the relevant procedures of the trial, voluntarily participate in the clinical trial, and sign the informed consent form (ICF);
2. The age requirement for signing the ICF is 18 years old or above, with no gender restrictions;
3. During screening, the diagnosis of atopic dermatitis should be met according to the Hanifin-Rajka criteria;

Exclusion Criteria:

1. Skin damage or abnormalities that may affect the evaluation of the administration site of the investigational drug;
2. Skin diseases that are contraindicated in research or affect the evaluation of drug administration sites, including but not limited to psoriasis, acne, and skin cancer;
3. Suffering from autoimmune diseases other than AD, such as inflammatory bowel disease and rheumatoid arthritis, and the researchers believe that this disease will be detrimental to the evaluation of this study;
4. Current history of or presence of lymphoproliferative disorders, or signs or symptoms suggesting possible lymphoproliferative disorders, including lymphadenopathy or splenomegaly;
5. Various malignant tumors, or any history of malignant tumors within the past 5 years prior to screening (excluding completely resected cervical carcinoma in situ, non metastatic squamous cell carcinoma, basal cell carcinoma, or papillary thyroid carcinoma);

Primary outcomes:
measure: Changes in EASI（Eczema area and severity index） from baseline
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Chinese Academy of Medical Sciences Hospital of Skin Disease
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Medical Sciences Hospital of Skin Disease
name: Qian jin Lu
role: PRINCIPAL_INVESTIGATOR
References: