louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06029855: Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy
Official title: Effects Of Kabat Rehabilitation Versus Mime Therapy On Facial Disability And Synkinesis In Patients Of Bell's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell Palsy
Keywords: Bell Palsy
Kabat Rehabilitation
Mime Therapy
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 85
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial paralysis. It is one of the most common neurological disorders of the cranial nerves.

Detailed description: Bell's palsy is an alarming condition of rapid onset, which paralyzes half of the facial muscles. Kabat rehabilitation is a manual resistance technique that promotes a basic pattern of movement through facilitation, inhibition, and resistance of a group of muscles. It increases the functioning and power of facial muscles while Mime therapy results in immediate improvement of function and integrity of facial muscles. It also mitigates synkinesis in Bell's palsy. Both techniques are easy to apply. They are clinically important techniques that are easily understood by patients.

Eligibility criteria: Inclusion Criteria:

1. Age group 25-50 years.
2. Both male and female.
3. Unilateral bell's paralysis.
4. Not congenital in origin.
5. Sub-acute and chronic cases.

Exclusion Criteria:

1. Other neurological deficits include epilepsy and Alzheimer's disease.
2. Traumatic onset.
3. Surgical reconstruction (nerve or muscle reconstruction).
4. Mental and psychological disorders i.e., schizophrenia, bipolar disorders.
5. Skin diseases (eczema, urticarial) as electrical stimulation may affect the results.
6. Any contraindications for massage like sunburn, bruising, or cuts.

Primary outcomes:
measure: Change in Synkinesis
timeFrame: It will be assessed at baseline, at the third week and at six week.
measure: Level of Facial Disability
timeFrame: Change in functional status will be measured at the baseline, at 3rd week and at 6th week.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Ashfaq Dr Ahmed, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01765855: An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects
Official title: AN OPEN-LABEL, SINGLE-DOSE, MASS-BALANCE STUDY TO ASSESS THE DISPOSITION OF 14C-LABELED PRT054021 IN HEALTHY MALE SUBJECTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health Volunteers
Keywords: Betrixaban
Healthy
Mass Balance
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 5
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy adult men ages of 19 and 55 years old, inclusive
* weighs at least 132 lbs

Exclusion Criteria:

* Clinically significant comorbid disease
* History of substance abuse
* Hemoglobin less than 12.0 g/dl

Primary outcomes:
measure: mean (max, tmax, AUC)
timeFrame: Over 336 hours
Secondary outcomes:
measure: Percent dose recovered in urine and feces
timeFrame: Over 336 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00660855: A Multicenter, Open Label Trial To Evaluate Pain Relief With Intravenous Followed By Oral Therapy With Parecoxib/Valdecoxib 40 Mg/Day For Treatment Of Post-Laparoscopic Surgery Pain
Official title: A Multicenter, Open Label Trial To Evaluate Analgesic Effect Of Intravenous And Subsequent Oral Therapy With Parecoxib/Valdecoxib (Bextra® IM/IV And Bextra®) 40 Mg/Day For Treatment Of Post-Laparoscopic Surgery Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Post Surgical
Keywords: laparoscopy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study were to assess the analgesic efficacy and safety of parecoxib/valdecoxib on post-laparoscopic surgery analgesia.

Detailed description: This study A3471107 was terminated on February 4th, 2005 due to enrollment difficulties, problems related to need for rescue medication, and perceptions about cardiovascular risk potentially associated with all NSAIDs.

Eligibility criteria: Inclusion Criteria:

* Patients who had undergone laparoscopic surgery
* Patients in need of post-surgical analgesia

Exclusion Criteria:

* Patients with an unexpected surgical complication which, in the Investigator's opinion, placed the patient at significantly higher risk for post-surgical complication(s), or for non-routine post-operative care requirements
* Patients who took any nonsteroidal anti-inflammatory drug or any analgesic within 48 hours prior to surgery

Primary outcomes:
measure: Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline
timeFrame: Day 3
Secondary outcomes:
measure: Visual Analog Scale Pain Intensity
timeFrame: Day 7
measure: Categorical Pain Intensity
timeFrame: Day 3 and Day 7
measure: Patient pain relief
timeFrame: Day 3 and Day 7
measure: Composite Upper Gastrointestinal (UGI) Tolerability measure was calculated; an UGI event was considered if the patient reported at least one of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe
timeFrame: Study endpoint
measure: Dyspepsia
timeFrame: Study endpoint
measure: Adverse events
timeFrame: Day 1, Day 3, and Day 7
measure: Patient Global Evaluation
timeFrame: Day 3 and Day 7
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04419155: ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients
Official title: ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: Collège des Pneumologues des Hôpitaux Généraux
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Lung Cancer histologically or cytologically proven between January 1st and December 31st, 2020

Brief summary: The prognosis for primary lung cancer (PLC) is very limited. In France, patients diagnosed for PLC in 2010 and followed in Respiratory Medicine or Oncology department of a General Hospital Centre had a 5-year survival rate of 12.7% (vs 10% in 2000).

Over the last ten years, substantial improvements have been made both in terms of diagnostic (immunohistochemistry and molecular biology) and therapeutic. New treatments have been marketed and are now available in clinic.

New therapeutical strategies have been launched and have proved their efficacy in clinical studies or meta-analyses, generally increasing the survival rate of patients by a few months. However, little information still exists on the use and effectiveness of these molecules in clinical practice.

The CPHG proposes to complete the information collected during KPB-2020-CPHG study by the ESCAP-2020-CPHG study that is a follow-up of therapeutical strategies over the first 3 years of treatment. This study should improve knowledge of the PLC treatment management in General Hospital Centres.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Primary Lung Cancer histologically (or cytologically or presence of a mutation on liquid biopsy with compatible imaging) proven between January 1st and December 31st, 2020\*
* Follow-up by a lung specialist at a General Hospital
* Oral informed consent \* date of collected sample

Exclusion Criteria:

* Age \< 18 years
* Secondary lung cancer
* Recurrence of same histological type PLC- left to the investigator discretion according to the clinic and the imagery
* Previous enrolment in the study
* Freedom deprived patient following a legal or administrative decision
* Patient unable to give his(her) consent

Primary outcomes:
measure: Describe therapeutical strategies implemented by pulmonologists in Respiratory Medicine or Oncology department of a General Hospital Centres during the first three years following PLC diagnosed in KBP-2020-CPHG cohort patients.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College)
Study officials:
References:
Clinical trial NCT05468255: The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active Adults
Official title: The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glucose Intolerance
Exercise
Vascular Function
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if an acute bout of removal of exercise reduces enothelial function and glycemic control in an active, older adult population; and whether a 3 day return to exercise restores this response. Glycemic control is the blood glucose response following the consumption of a meal. It is an indicator of insulin resistance (or type 2 diabetes) and impaired glycemic control has been suggested to lead to cardiovascular disease. Endothelial function has been shown to be improved by chronic or acute increases in physical activity. Both of these have been shown to be impaired to acute bouts of inactivity in young populations; however the impact of acute inactivity in older adults is less understood. In this proposal the investigators will examine 1)how quickly impairments in glycemic control occur to acute physical inactivity in older adults who exercise, 2) how quickly impairments in endothelial function occur to acute inactivity in older adults who exercise, and 3) whether 3 days of a return to exercise restores these responses.


Eligibility criteria: Inclusion Criteria:

1. 55 years and older, 18-40 years old
2. Healthy, physically active, performing at least 90 min/week of physical activity
3. Free of physical limitations that may interfere with alterations in daily physical activity levels

Exclusion Criteria:

1. Physician diagnosed HIV, hepatitis, or tuberculosis.
2. Body weight change of greater than 5% within the previous 2 months
3. Smoking within the previous 2 months.
4. Taking medications that alter blood glucose levels

Primary outcomes:
measure: Continuous glucose monitoring
timeFrame: 3 days before removal of exercise
measure: Continuous glucose monitoring
timeFrame: After removal of exercise for 5 days
measure: Continuous glucose monitoring
timeFrame: After return to exercise for 3 days
measure: Flow mediated dilation
timeFrame: 3 days before removal of exercise
measure: Flow mediated dilation (vascular health)
timeFrame: After removal of exercise for 5 days
measure: Flow mediated dilation (vascular health)
timeFrame: After return to exercise for 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Old Dominion University
state: Virginia
Study officials:
References:
Clinical trial NCT00212355: Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Official title: Phase3, Open-Label, Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wilson's Disease
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 37
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this long-term study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.

Detailed description: Wilson disease is an autosomal recessive disorder with copper metabolism. In Japan, the standard treatment is the use of copper chelating agents, such as D-penicillamine and trientine. In this study, we investigate efficacy on zinc acetate in Japanese patients with Wilson disease.

Eligibility criteria: Inclusion Criteria:

* Wilson's disease(adult, infant, pregnant woman)

Exclusion Criteria:

* Acute hepatitis
* Malignant tumor

Primary outcomes:
measure: Safety and Efficacy
timeFrame: During study period (up to 96W )
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National MINAMIYOKOHAMA Hospital
name: Koudou Ishii, M.D.
role: STUDY_DIRECTOR
References:
citation: Shimizu N, Fujiwara J, Ohnishi S, Sato M, Kodama H, Kohsaka T, Inui A, Fujisawa T, Tamai H, Ida S, Itoh S, Ito M, Horiike N, Harada M, Yoshino M, Aoki T. Effects of long-term zinc treatment in Japanese patients with Wilson disease: efficacy, stability, and copper metabolism. Transl Res. 2010 Dec;156(6):350-7. doi: 10.1016/j.trsl.2010.08.007. Epub 2010 Sep 23.
Clinical trial NCT00472914: Use of EMG to Assess Clinical Hypertonia
Official title: Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Hypertonia
Spasticity
Dystonia
Rigidity
Keywords: Hypertonia
Childhood
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2007-05-14
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: A handheld surface electromyography device will be tested by clinicians on children with limb hypertonia, and inter-rater reliability will be assessed with and without the device.

Detailed description: Hypothesis:

Qualitative surface EMG measurement during passive movement will increase the inter-rater reliability of clinicians for diagnosis of spasticity and dystonia in children with hypertonia.

Specific Aims:

1. Develop a handheld surface EMG device with auditory output that can be used similarly to a stethoscope to listen non-invasively to the activity of muscles.
2. Provide clinicians at 5 different institutions with a device to test for 2 months in their own clinics.
3. Bring all 5 clinicians to Stanford University for a single-day exercise in which each clinician will examine 10 children with hypertonia. Each clinician will rate the children without using the device, and then again with the device. Intra-class correlations and kappa statistics will be used to assess whether the use of the device leads to improved inter-rater reliability.

Eligibility criteria: Inclusion Criteria:

* Age 6-18
* hypertonia in at least one limb due to spasticity

Exclusion Criteria:

* any condition that would increase the risk of participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Terence D Sanger, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03462914: Comparative Study Between Different Approaches to CPA-petroclival Meningiomas
Official title: Comparative Study Between Different Approaches to CPA -Petroclival Meningiomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Neoplasms
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with meningioma

Brief summary: • Give an effective treatment for CPA-petroclival meningiomas and can detect the best approach for these tumors.

. Improve the outcome of these patients and decease rate of recurrence.

Detailed description: There are several lesions arising in the petroclival region. The most frequent tumor is the petroclival meningioma, followed by chondrosarcomas, chordomas, schwannomas of the cranial nerves V and VII, and other malignant tumors \[1, 2, 3, 4, 5\].

Petroclival meningiomas are tumors of the skull base that present a formidable challenge to surgical resection because of their deep location and relationship to vital neurovascular structures. In the majority of the cases they are benign tumors, but may involve or infiltrate the skull base bone, the dura mater, the brainstem, and all important neurovascular structures of this region. The petroclival region comprises the anatomical location of the body of the sphenoid bone, the anterior central portion of the occipital bone, and is bordered on the lateral aspect by the petrous apex. The roof of this space is formed by the petroclival ligaments and the tentorium. This space contains important neurovascular structures that are frequently involved or displaced by the tumor in a variable pattern. The basilar artery with its branches may be embedded or displaced by the meningioma. The petrosal vein is often displaced posteriorly by the tumor. Cranial nerves III and IV are usually displaced upwardly and the nerve VI is often surrounded by tumor. Petroclival meningiomas have their origin medial to cranial nerves V, VII, VIII, IX, X, and XI, and reach the tentorium . They frequently extend to the middle cranial fossa, cavernous sinus, prepontine space, and down to the foramen magnum. These tumors frequently compress the brainstem making total removal very difficult or impossible without neurologic deficits. cerebellopontine angle (CPA) and low clivus meningiomas may reach these areas. These lesions usually need different surgical approaches as transpetrosal approach ( anterior, modified and combined ) and retrosigmoid approach

Eligibility criteria: Inclusion Criteria:

* Patient with a single lesion .
* Patient with a denovo lesion.

Exclusion Criteria:

* Patient with recurrent lesions.
* Patient with lesions after adjuvant therapy.

Primary outcomes:
measure: The success rate of surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Spetzler RF, Hamilton MG, Daspit CP. Petroclival lesions. Clin Neurosurg. 1994;41:62-82. No abstract available.
Clinical trial NCT03340714: Automated Device for Asthma Monitoring and Management in Monitoring Adults With Lung Cancer Undergoing Radiation Therapy
Official title: A Pilot Study Investigating the Feasibility of ADAMM (Automated Device for Asthma Monitoring and Management) in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Health Care Originals, Inc.
First posted: 2017-11-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic and non-metastatic lung cancer being treated with radiotherapy

Brief summary: This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. The Automated Device for Asthma Monitoring and Management may provide useful information to doctors to help monitor adult patients with lung cancer and diagnose certain conditions earlier than traditional means.

Detailed description: PRIMARY OBJECTIVES:

I. Determine compliance with the Automated Device for Asthma Monitoring and Management (ADAMM) device in patients receiving radiation therapy (RT) for lung cancer.

SECONDARY OBJECTIVES:

I. Evaluate feasibility of recruitment, acceptability of the ADAMM device, and compliance with electronic patient-reported outcomes (ePROs) in this patient population

Eligibility criteria: Inclusion Criteria:

* Patients are capable of giving informed consent
* Patients are eligible to be treated with RT and plan to start treatment
* Patients have either metastatic or non-metastatic lung cancer as defined in history and physical
* Patients must be able to read or speak English
* Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan

Exclusion Criteria:

* Patients who cannot read or speak English
* Patients who are not candidates for RT treatment
* Women of childbearing potential who are pregnant or breastfeeding

Primary outcomes:
measure: Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device
timeFrame: Up to 4 weeks post-radiation therapy
measure: Percentage of days per study period that patients wear the Automated Device for Asthma Monitoring and Management device
timeFrame: Up to 4 weeks post-radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Maria Werner-Wasik, MD
role: PRINCIPAL_INVESTIGATOR
References: