louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00765726: Study Evaluating The Safety Of Xyntha In Usual Care Settings
Official title: A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemophilia A
Keywords: hemophilia
hemophilia A
ReFacto
Xyntha
moroctocog alfa
bleeding disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 12
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.

Detailed description: The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF.

The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.

Eligibility criteria: Inclusion Criteria:

* Male patients 12 years of age and older.
* Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products.
* Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit.
* Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy.

Exclusion Criteria:

* Bleeding disorder other than hemophilia A.
* Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy.
* Immunomodulatory therapy during screening period.
* Known hypersensitivity to hamster protein.

Primary outcomes:
measure: Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
timeFrame: Month 24 or early withdrawal
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: East Lansing
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Christchurch
country: New Zealand
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06267326: World Health Organization (WHO) , COVID19 Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt
Official title: Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mucormycosis; Rhinocerebral (Etiology)
COVID-19
Lead sponsor: Nasser Institute For Research and Treatment
Sponsor class: OTHER_GOV
First posted: 2024-02-20
Enrollment: 35
Sex: ALL
Minimum age (years): 22
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection


Eligibility criteria: Inclusion Criteria:

* all patients with mucormycosis post covid 19

Exclusion Criteria:

* The patient not suffered from covid 19

Primary outcomes:
measure: 35 patients suffering from mucormycosis infection post covid 19
timeFrame: 2 years
measure: 25 patients were cured with comorbidity and 10 pateints died
timeFrame: 2 years
measure: pain
timeFrame: two years
Secondary outcomes:
measure: Visual Analog Score for pain
timeFrame: 2years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Omar Elmonofy
Study officials:
References:
Clinical trial NCT02867826: The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
Official title: The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ampulla of Vater Intestinal-Type Adenoma
Keywords: Endoscopy
Ampulla of Vater
Duodenoscopy
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.

Detailed description: The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.

Eligibility criteria: Inclusion Criteria:

* Cap-assisted endoscopy
* Referral to endoscopic examination of ampulla of Vater

Exclusion Criteria:

* Patients with surgically modified anatomy.
* Obstruction of the upper gastrointestinal tract.
* Contra-indication for endoscopy.
* Absence of informed consent.

Primary outcomes:
measure: Visualization rates of the ampulla of Vater
timeFrame: Up to 30 minutes during gastrointestinal endoscopy
Secondary outcomes:
measure: Rates of complications for both groups.
timeFrame: Up to 3 hours after upper endoscopy
measure: Additional time required for Cap-assisted endoscopy
timeFrame: Up to 30 minutes during upper endoscopy
measure: Need for additional sedation required for the Cap-assisted endoscopy.
timeFrame: Up to 30 minutes during upper endoscopy
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
Study officials:
affiliation: Barretos Cancer Hospital
name: Denise P Guimarães, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva LC, Arruda RM, Botelho PFR, Taveira LN, Giardina KM, de Oliveira MA, Dias J, Oliveira CZ, Fava G, Guimaraes DP. Cap-assisted endoscopy increases ampulla of Vater visualization in high-risk patients. BMC Gastroenterol. 2020 Jul 9;20(1):214. doi: 10.1186/s12876-020-01361-5.
Clinical trial NCT02185326: Microflare Protocol in Poor Responders
Official title: Growth Hormone Co-treatment With the Microflare Stimulation Protocol in IVF/ICSI, Can it be a New Hope for Poor Responders?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility Due to Diminished Ovarian Reserve
Keywords: Poor responders
Poor ovarian response
IVF/ICSI
Microflare protocol
Growth hormone
Oral contraceptive pills
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 145
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders

Detailed description: The microflare as a method of down regulation protocol can be used to prepare the females suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying to outline its effect on the clinical pregnancy rate as a main primary outcome, and to compare its use with the addition of growth hormone to the same protocol.

Eligibility criteria: Inclusion Criteria:

* females fulfilling the criteria of the ESHRE consensus 2011:

At least two of the following three features must be present:

(i) Advanced maternal age (≥40 years) or any other risk factor for POR; (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).

Exclusion Criteria:

* women who suffer from any other cause of infertility other than poor ovarian reserve
* refusal of the patient to consent for using her data in the study.

Primary outcomes:
measure: Clinical pregnancy rates
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina M Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bayoumi YA, Dakhly DM, Bassiouny YA, Hashish NM. Addition of growth hormone to the microflare stimulation protocol among women with poor ovarian response. Int J Gynaecol Obstet. 2015 Dec;131(3):305-8. doi: 10.1016/j.ijgo.2015.05.034. Epub 2015 Aug 23.
Clinical trial NCT04429126: Acupressure in Reducing Post-TBI Fatigue
Official title: The Effect of Acupressure on Relieving Fatigue Following Traumatic Brain Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fatigue is a common symptom experienced by patients with traumatic brain injury (TBI). Prior works have demonstrated that it may profoundly impact the ability to return to productive activity and cognitive functions. However, few interventions have been applied in this population.The purpose of the current will be to test the effect of acupressure on fatigue reduction after traumatic brain injury.

Detailed description: Fatigue is a pervasive and critical long-lasting symptom experienced by patients with traumatic brain injury (TBI) and can persist up to months or years after head injury. However, thus far, only few non-pharmacological interventions, such as mindfulness, are implemented in reducing fatigue in TBI survivors. Prior works have suggested that acupressure can significantly improve fatigue in different populations, such as cancers survivors and patients with hemodialysis. Therefore, we would like to test whether acupressure effectively improve fatigue after TBI.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with traumatic brain injury over 6 months with initial GCS (admitted GCS) from 3-12.
* Aged between 20-65 years
* Are able to communicate in Chinese and Mandarin
* Are able to complete the questionnaires
* Complain of tiredness and cannot be restored even after a rest.
* No physical disability and visual impairment

Exclusion Criteria:

* With skin lesion
* had diagnosis of neuropathy and paraesthesia prior to study.

Primary outcomes:
measure: Fatigue
timeFrame: 4 weeks
Secondary outcomes:
measure: Memory function
timeFrame: 4 weeks
measure: Attention function
timeFrame: 4 weeks
measure: Heart rate variability
timeFrame: My ECG E3-8010
measure: Brain waves
timeFrame: 4 weeks
measure: Sleep quality
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Hsiao-Yean Chiu
Study officials:
affiliation: School of Nursing, Taipei Medical University
name: Hsiao-Yean Chiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05110326: Ergon Technique Versus PNF Stretching on Hamstring Flexibility in Knee Osteoarthritis
Official title: Comparison of Ergon Technique Versus Proprioceptive Neuromuscular Facilitation Stretching on Hamstring Flexibility in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
Ergon Technique
Proprioceptive Neuromuscular Facilitation stretching
Active Knee Extension Test
Western Ontario and McMaster Universities Arthritis Index
Visual Analogue Scale
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 57
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 60 participants will be taken. Patients will be divided into two groups (A\&B) of 30 participants in each group by sealed envelope method. Hot pack will be applied to both groups for 15 minutes at the start of intervention. ERGON Technique(IASTM) will be applied to group A along with strengthening exercise. Proprioceptive Neuromuscular Facilitation (PNF) stretching will be given to group B along with strengthening exercise. A 35 minute session will be given to the patients and 3 sessions will be given once a week. Intervention will be given for 6 weeks. The outcome measure will be Visual analog Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Active Knee Extension Test (AKE) will be measured at baseline and at the end of 6th week. Data will be analyzed by SPSS 22.


Eligibility criteria: Inclusion Criteria:

* Unilateral/bilateral osteoarthritis
* Participants with unilateral/bilateral hamstring tightness
* 200 from Active Knee Extension test
* Grade 1 and 2 in Kellgren and Lawrence criteria for knee osteoarthritis

Exclusion Criteria:

* Participant failing to fall in the category below will be excluded from the study:
* Any lower extremity injury in past 3 months
* Any fracture or surgery done for pelvis, hip or knee.
* Any neurological symptoms.
* Any recent knee reconstructive surgery
* Burns of lower extremities
* Other musculoskeletal disorders associated with knee joint, Iliotibial band, adductor muscle and Sartorius muscle tightness

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 6 Weeks
measure: Western Ontario and McMaster Universities Arthritis Index(WOMAC)
timeFrame: 6 Weeks
measure: Active Knee Extension Test
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: RHS Rehabilitation Centre
Study officials:
affiliation: Riphah International University
name: Waqar Ahmed Awan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04371926: Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk
Official title: Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Symptomatic patients will be randomized to hydroxychloroquine (HCQ) vs no-HCQ group.

Similarly, hospital staff with high risk of exposure will be randomized to HCQ vs no-HCQ group
Primary purpose: PREVENTION

Brief summary: Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.

Detailed description: This study is designed to evaluate the prophylactic efficacy of HCQ in COVID-19 cases with mild to moderate symptoms and in the hospital staff engaged in attending infected patients.

Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years of age at the time of enrollment
* COVID-19 test positive patients with mild-moderate symptoms including fever \>37.50 F
* Consecutive consenting staff at ICU, ER and COVID-19 unit that have never been diagnosed with COVID-19

Exclusion Criteria:

* Exclusion criteria:
* Hepatic cirrhosis or active hepatitis B or C
* Severe renal disease
* Hospitalized for severe symptoms of COVID-19 (ARDS), on mechanical ventilation or ECMO
* Contraindication to HCQ
* Using HCQ for some other condition (i.e. SLE, rheumatoid arthritis)
* Pregnant or breast feeding
* Known history of long QT syndrome (QTc \>500 ms on electrocardiogram)
* Seizure disorder
* Body weight \<50kg
* Psoriasis
* Unwilling to provide informed consent

Primary outcomes:
measure: Time to reach normal body temperature
timeFrame: 1 month
measure: Development of COVID-19 symptoms during HCQ preventive therapy in staff
timeFrame: 1 month
Secondary outcomes:
measure: COVID-19 test result at follow-up in patients
timeFrame: 6 days
measure: Worsening of symptoms in COVID-19 patients
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: St. David's Medical Center
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05712226: Sleepiz One+ Versus Capnography and Electrocardiography
Official title: Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Hypertension
Sleep Apnea
Asthma
Heart Diseases
Respiratory Disease
Lead sponsor: Sleepiz AG
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: EtCO2, or exhaled carbon dioxide, is a non-invasive and commonly used measure for respiratory rate and function. It can be easily monitored using a device called a capnograph, which consists of a sensor that is placed near the patient's mouth or nose and a monitor that displays the concentration of carbon dioxide in the respiratory gases in real-time.

EtCO2 capnography is generally considered a reliable and accurate method for monitoring respiration and is often used as a gold standard for comparing the performance of other methods for measuring respiration.

Therefore, the primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ and EtCO2 Capnography for measuring respiration rate, in healthy adults and patients suffering from chronic conditions (e.g. hypertension, COPD, asthma, diabetes), at rest in a clinical setting. Additionally, the performance of heart rate estimation will be evaluated against ECG.


Eligibility criteria: Inclusion Criteria:

Patients:

* Age \>=18years
* Informed Consent as documented by signature
* One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)

Healthy volunteers

* Age \>=18years
* Informed Consent as documented by signature
* No diagnosed chronic medical condition

Exclusion Criteria:

Patients

* Previous enrolment into the current study,
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant

Healthy volunteers:

* Previous enrolment into the current study,
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant
* Presence of diagnosed chronic medical condition

Primary outcomes:
measure: Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed.
timeFrame: 60s
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schlaflabor Fluntern
state: Zurich
Study officials:
References:
Clinical trial NCT00894426: Patient's Perception in Symptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease
Official title: Prospective, Observational, Multi-center, Non-interventional Study to Assess Patients Perception in SYmptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Symptom
Morning activity
Questionnaire
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The inclusion/exclusion criteria are designed to select subjects suffering from severe COPD (according to spirometric classification, GOLD stage III and IV) and in a stable state

Brief summary: The aim of this study is to assess the perception of chronic obstructive pulmonary disease (COPD) patients in symptoms related to morning activities. Also the researchers investigated how to describe the impact of symptoms on sleep quality and how to use the medication in Korea COPD treatments.


Eligibility criteria: Inclusion Criteria:

* COPD outpatients over 45 years old
* Lung function: post-FEV1 \< 50%
* Current or ex-smoker \> 10 packs per year
* Patients who were not on medication of ISC/FC at least 2 weeks

Exclusion Criteria:

* Ongoing exacerbation of COPD or within the previous 3 months
* History of asthma or allergic rhinitis
* Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
* Current participation in an interventional clinical trial

Primary outcomes:
measure: To assess the perception of COPD Patients in symptoms related to morning activities
timeFrame: At baseline and last visit (after 2~3 months)
Secondary outcomes:
measure: To assess the patient's perception of the variability of symptoms
timeFrame: At baseline and last visit (after 2~3 months)
measure: To describe how patients use their COPD treatments
timeFrame: At baseline and last visit (after 2~3 months)
measure: To investigate factors that may influence the patient's perception of symptom variability (such as patient characteristics, COPD treatments, co morbidities, etc…)
timeFrame: At baseline and last visit (after 2~3 months)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Gyongiju
country: Korea, Republic of
facility: Research Site
city: Pohang
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Astrazenca Korea, Medical Department
name: Joonwoo Bahn
role: STUDY_DIRECTOR
References: