louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00377065: Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)
Official title: Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: HIV Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-15
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is patient driven. Investigators are not proactively assigned. There is no target sample size and duration of the study is indefinite. For information on how to enroll in the study, see link below.


Eligibility criteria: Inclusion Criteria:

* HIV positive patients who have limited or no treatment options and have documented resistance

Exclusion Criteria:

* Patient has previously been on MK0518 therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03084965: Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan
Official title: Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-03-21
Enrollment: 1987
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 Diabetes Mellitus patients on Dapagliflozin Therapy in Taiwan

Brief summary: Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan.


Eligibility criteria: Inclusion Criteria:

1. Outpatient equal to or more than 20 years of age.
2. T2DM patient initiated dapagliflozin after May 1st 2016 as a second line or third line oral anti-diabetic therapy, either as add-on or switching from one to another. Or initiating dapagliflozin as adjunctive therapy for T2DM subjects treated with insulin.
3. Completed follow-up of at least 6 months regardless of continuation on dapagliflozin therapy.
4. Will provide completed and signed written informed consents.

Exclusion Criteria:

1. Subjects with a history of SGLT2 inhibitor therapy other than dapagliflozin prior to Baseline.
2. Subjects with Type 1 diabetes.
3. Treatment with other investigational drugs concurrently during the retrospective data collection period.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Research Site
city: Chiayi
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: New Taipei
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
Study officials:
References:
Clinical trial NCT04451265: Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy
Official title: Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuro-Ophthalmology
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-06-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected NOIA, discussed after clinical examination by a specialist ophthalmologist

Brief summary: The patient presents to the ophthalmological emergencies and / or to the internal medicine department. NOIA clinical discovery Patient referred in radiology for brain and visual MRI. The two sequences added by the research (8 minutes) will be added to that of the treatment.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Patient with suspected NOIA, evoked after clinical examination by a specialized ophthalmologist
* For which a brain and visual MRI is planned
* Express consent to participate in the study
* Affiliate or beneficiary of a Social Security scheme

Exclusion Criteria:

* Contraindication to MRI (electrical device, metallic foreign body, claustrophobia)
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Study the sensitivity of the High resolution Diffusion sequence in the detection of NOIA, evaluated by a DWI hypersignal and an ADC hyposignal of the optic nerve
timeFrame: basline
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de LILLE
city: Paris
country: France
facility: Fondation A De Rothschild
city: Rouen
country: France
facility: Chu Rouen
Study officials:
References:
Clinical trial NCT03231865: Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX
Official title: Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-deficiency
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients prior to a surgery, seen in the Anesthetic clinic for evaluation

Brief summary: ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non invasively. Non invasive and invasive optical measurement of ZnPP will be compared. Additionally ZnPP measurements will be compared to other iron deficiency parameters for validation by the investigators.

Detailed description: Zinc-protoporphyrin (ZnPP) will be measured by a fluorescence technique. Restricted wave light (407/425 nm) is used to detect ZnPP in the bloodstream non-invasively through the oral mucosa. The spectroscopic measurements are translated into a ZnPP value (mumol/mol heme).

The non-invasive measurement of ZnPP is validated and compared to optical measurement of ZnPP in whole blood and high performance liquid chromatography (HPLC) measurement of ZnPP in whole blood.

The ZnPP value is compared to other iron-deficiency parameters: Ferritin, Transferrin saturation and soluble Transferrin receptor.

Eligibility criteria: Inclusion Criteria:

* Patients seen preoperatively in the Anesthestic clinic
* Patients \> 18 years of age
* Understood and signed patient consent

Exclusion Criteria:

* transfusion of blood products 8 weeks prior to screening
* Pregnancy
* Porphyria

Primary outcomes:
measure: Validation of the non-invasive ZincProtoporphyrinIX measurement
timeFrame: Baseline
Secondary outcomes:
measure: Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters
timeFrame: Baseline
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Institute of Anesthesiology, University and University Hospital Zurich
name: Philipp Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hennig G, Homann C, Teksan I, Hasbargen U, Hasmuller S, Holdt LM, Khaled N, Sroka R, Stauch T, Stepp H, Vogeser M, Brittenham GM. Non-invasive detection of iron deficiency by fluorescence measurement of erythrocyte zinc protoporphyrin in the lip. Nat Commun. 2016 Feb 17;7:10776. doi: 10.1038/ncomms10776.
Clinical trial NCT02878265: The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children
Official title: The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: malaria
vitamin A
Zinc
Multivitamin
Lead sponsor: University of Ghana
Sponsor class: OTHER
Collaborators: name: Kwame Nkrumah University of Science and Technology
First posted: 2016-08-25
Enrollment: 547
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity

Detailed description: A total of 542 children aged between 6-59 months received either: (i) VA (control) or (ii) VA \& Z (VAZ) or (iii) VA, Z \& MV (VAZM). VA was delivered as a single dose while MV and Z were delivered daily. Malaria cases were managed by community health workers, who used rapid diagnostic test to confirm infection prior to treatment.

Eligibility criteria: Inclusion Criteria:

* under 5years
* will stay in the community for 10years

Exclusion Criteria:

* chronic diseases

Primary outcomes:
measure: Incidence of clinical malaria attacks
timeFrame: Baseline and every month up to six months
Secondary outcomes:
measure: Incidence of diarrhea attacks
timeFrame: Every month up to six months
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Amoako
Study officials:
affiliation: Kwame Nkrumah Univeristy of Science and Technolgy
name: Patricia k Brown, PhD
role: STUDY_CHAIR
affiliation: University of Ghana
name: Wilhelmina A Mensah, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veenemans J, Milligan P, Prentice AM, Schouten LR, Inja N, van der Heijden AC, de Boer LC, Jansen EJ, Koopmans AE, Enthoven WT, Kraaijenhagen RJ, Demir AY, Uges DR, Mbugi EV, Savelkoul HF, Verhoef H. Effect of supplementation with zinc and other micronutrients on malaria in Tanzanian children: a randomised trial. PLoS Med. 2011 Nov;8(11):e1001125. doi: 10.1371/journal.pmed.1001125. Epub 2011 Nov 22.
citation: Zeba AN, Sorgho H, Rouamba N, Zongo I, Rouamba J, Guiguemde RT, Hamer DH, Mokhtar N, Ouedraogo JB. Major reduction of malaria morbidity with combined vitamin A and zinc supplementation in young children in Burkina Faso: a randomized double blind trial. Nutr J. 2008 Jan 31;7:7. doi: 10.1186/1475-2891-7-7.
citation: Owusu-Agyei S, Newton S, Mahama E, Febir LG, Ali M, Adjei K, Tchum K, Alhassan L, Moleah T, Tanumihardjo SA. Impact of vitamin A with zinc supplementation on malaria morbidity in Ghana. Nutr J. 2013 Sep 23;12:131. doi: 10.1186/1475-2891-12-131.
citation: Imdad A, Herzer K, Mayo-Wilson E, Yakoob MY, Bhutta ZA. Vitamin A supplementation for preventing morbidity and mortality in children from 6 months to 5 years of age. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008524. doi: 10.1002/14651858.CD008524.pub2.
Clinical trial NCT04407065: Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles
Official title: Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility, Female
Keywords: IVF
HCG
GnRH agonist trigger
Lead sponsor: Riyadh Fertility and Reproductive Health center
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the oocytes yield in patients with history of poor oocytes yield, despite normal response to COH, due to low (\<50%) number of oocytes retrieved per number of follicles \> 14 mm in diameter on day of hCG administration


Eligibility criteria: Inclusion Criteria:

* Patients with history of poor oocytes yield in previous IVF attempt, despite normal response to COH, due to low (\<50%) number of oocytes retrieved per number of follicles \> 14 mm in diameter on day of hCG administration
* Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt

Exclusion Criteria:

* Endometriosis
* PCOS

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: First day after oocyte retrieval
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: First 5 weeks after oocyte retrieval
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Riyadh Fertility and Reproductive Health center
Study officials:
affiliation: Riyadh Fertility and Reproductive Health center
name: Usama M Fouda, Prof.
role: STUDY_DIRECTOR
References:
citation: Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77.
Clinical trial NCT04591665: Swallowing Difficult Sensation After Cervical Spine Surgery
Official title: Swallowing Changes in Cervical Spine Patients With Postoperative Dysphagia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Swallowing Disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients after cervical spine surgery, EAT-10 and older than 20 years old

Brief summary: In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive. The investigator aimed to examine the correlation between high-resolution manometric and videofluoroscopic measurements of the swallowing function.

Detailed description: Background: In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive.

Objectives: The objective of the current study was to examine the correlation between high-resolution manometric and videofluoroscopic measurements of the swallowing function.

Patients and methods: Consecutive patients who will fulfill the criteria of postoperative cervical spine surgery patients aged \>= 20 will be enrolled and the dysphagia questionnaire score (EAT-10) was higher than 3, including 3. After got the inform consent, these patients receive the swallowing function by videofluroscopy and HRIM.

Expected result: The investigator will evaluate the swallowing changes of these postoperative cervical spine patients with suspected dysphagia. The investigator expected that the highly correlation between the HRIM and VFSS.

Eligibility criteria: Inclusion Criteria:

* \> 20 years old
* postoperative cervical spine surgery
* EAT-10 questionnaire

Exclusion Criteria:

* pregnancy
* bleeding tendency
* heart or lung failure

Primary outcomes:
measure: pharyngeal pressure
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01110265: Attention Training and Its Effects on Body Image Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dissatisfaction
Eating Disorder Symptoms
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2010-04-26
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research has consistently found attentional biases towards negative weight-related stimuli in individuals with eating disorders. It has been suggested that these biases may act as a vulnerability factor for the development and maintenance of body dissatisfaction and may therefore be an important target for intervention. Previous studies have demonstrated the capacity to modify the patterns of attention allocation to threatening stimuli in a variety of anxiety disorders, with a subsequent and sustained reduction in anxiety symptoms. Thus, the present study aimed at testing the efficacy of attention training in reducing attentional biases and eating disorder symptoms in individuals with elevated levels of body image disturbance and eating disorder symptomatology of clinical severity. Thirty-two participants were randomly allocated to receive eight sessions of a 10-minute computer task aimed at training their attention away from weight-related stimuli or a control placebo training condition. Results showed that participants in the attention training group had a significantly greater reduction in their attentional bias and body dissatisfaction from pre- to post-training relative to the placebo condition. At follow-up, both groups showed a significant decrease in body dissatisfaction from their pre-training levels. The only significant difference between groups in eating disorder symptoms at follow-up was in terms of the attention training group experiencing a greater reduction in weight and shape concerns.


Eligibility criteria: Inclusion Criteria:

* If they have a score on the Body Shape Questionnaire of 113 or more AND a score in the EDE-Q of 4 or more in any subscale.

Exclusion Criteria:

* attention bias score of \<-10

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The University of Sydney
state: New South Wales
Study officials:
References:
Clinical trial NCT06008665: Effects of Action Observation Therapy With Otago Exercises on Balance and Quality of Life in Older Adults
Official title: Effects of Action Observation Therapy With Otago Exercises on Balance and Quality of Life in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Balance; Distorted
Lead sponsor: Riphah International University
Sponsor class: OTHER
Collaborators: name: Health Education Research Foundation (HERF)
First posted: 2023-08-23
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to determine to see the effect of action observation therapy with otago exercise on Balance and Quality Of Life.

Detailed description: This study is designed to reduce the Fall and balance problems and increase the quality of life in older adults. Balance, which declines with aging, is a complex sensory-motor process in which the visual, vestibular, and musculoskeletal systems work cooperatively to produce postural stability and loss of balance control causes falls, resulting in severe injuries, such as fractures, causing longstanding pain, lower quality of life, disability, and even death.

Interventions include balance and postural control that can help older people to avoid falling, through tai chi methods, gait training, strengthening exercises, and balance training programs.

The Otago Exercise Program comprises muscle strength exercises, balance training, and walking. The Otago workout program is based on individual tolerance, consisting of strengthening, balance, walking, and aerobic activities, and can be done at home environment Action observation is a cognitive intervention training strategy that involves observing other people's performance in order to promote motor learning.

Participants were instructed to watch a video on a screen while comfortably seated in a chair with armrests. They were not allowed to follow along or engage in any movement while watching the video. After the watching video of each component of otago exercises the exercises performed by participant based on the content of the video.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Participant experience fall \> one time in last 6 months.
* Participants having Berg Balance score between 20 to 40

Exclusion Criteria:

* ●Abnormalities in visual, auditory, or vestibular system
* Limb defects
* History of recent fractures
* Participants with Cardiovascular, Cerebrovascular disease or traumatic brain injury and Epilepsy

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline to 12th week
measure: Time Up and Go test
timeFrame: Baseline to 12th week
measure: Functional Reach Test
timeFrame: Baseline to 12th week
Secondary outcomes:
measure: Short Form 36
timeFrame: Baseline to 12th week
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Waqar Awan Awan
Study officials:
affiliation: Riphah International University
name: Waqar Ahmed Awan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00852865: Lactobacillus Farciminis and Hyperalgesia
Official title: Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Pain
Keywords: Inflammation
Pain
Lead sponsor: Lallemand SAS
Sponsor class: INDUSTRY
First posted: 2009-02-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a hyperalgesia on response to thermal stimulation. A comparaison of results before and after three weeks of treatment will be made.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* consumption of yogurts

Primary outcomes:
measure: Measurement of the mchanical pain threshold in primary and secondary areas by using a punctate stimulus.
Secondary outcomes:
measure: Measurement of cutaneous temperature of hyperalgesia areas
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Cpc / Cic-Inserm 501
Study officials:
affiliation: CPC/CIC-INSERM 501
name: Claude DUBRAY, Professor
role: PRINCIPAL_INVESTIGATOR
References: