cyrilzakka/clinical-trials huggingface dataset:
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure of high altitude on nocturnal breathing pattern.

Respiratory polygraphies will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and respiratory polygraphies will be performed on night 1 and 6. They will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants will return to the Santiago area (520 m) for a 6 day recovery period.

A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility Criteria:
Inclusion Criteria:

* born, raised and currently living \<800m
* No overnight stay at altitudes \>1500 m 4 weeks before the study

Exclusion Criteria:

* Previous altitude intolerance to altitude \<3000 m
* Pregnancy
* Health impairment, which requires regular treatment
Low Energy Diet and Familial Partial Lipodystrophy

To evaluate the therapeutic efficacy and metabolic impact of a low energy diet (LED) in people with familial partial lipodystrophy and diabetes. Participants will be provided with a LED (total diet replacement) for 12 weeks, before the introduction of a stepped food transition. Metabolic effects will continue to be assessed for 1 year. In order to better understand why this intervention changes insulin sensitivity, we will also collect adipose and muscle tissue samples at baseline and 12 weeks into the intervention in participants willing to have these procedures performed. These samples will be used for histological, metabolite, gene expression and protein expression analyses.


Eligibility Criteria:
Inclusion Criteria:

* Familial Partial Lipodystrophy
* Age \>= 18 yrs
* T2DM
* Willingness to check daily blood sugars
* HbA1c between 53mmol(7%)- 108 mmol(12%)
* Weight stable for 3 months
* Capacity to consent

Exclusion Criteria:

* Pregnancy
* Untreated thyroid dysfunction (patients who have been euthyroid on medication for at least 3 months can be included)
* Use of medication adversely that affects diabetes control (e.g. steroids/ immunosuppressants/ certain antipsychotics)
* Incapacity to give informed consent
* History of an eating disorder/ purging behaviour
* Previous gastric bypass/ banding
* Use of Leptin Therapy
* Untreated retinopathy
Alzheimer's and Blood Glucose Levels

The Alzheimer's and Blood Glucose Levels Study is researching the differences in blood glucose levels between people with and without Mild Cognitive Impairment or Alzheimer's disease with the aim of early detection of Alzheimer's Disease.

This study will collect continuous glucose monitor (CGM) data from participants already using CGMs to better understand the relationship between Alzheimer's Disease and blood glucose levels. This study will use the " Endobits Companion " app for data collection. The Endobits Companion app is freely available for Android and iOS mobile devices, and was designed to keep track of patients diabetes management through a journal and relay this information with their CGM readings to their caring physician.

Eligibility Criteria:
Inclusion Criteria:

* For the case group: have been diagnosed with MCI or AD within the past 5 years.
* For the control group: have not been diagnosed with MCI or AD or another major dementia disease
* Currently using a continuous glucose monitor (CGM).
* Willing and able to provide informed consent, and to have their data collected through the Endobits Companion app. If the participant themself is unable to provide informed consent, it will be sought from their primary caregiver.

Exclusion Criteria:

* Patients younger than 50 years of age.
* Patients with a BMI lower than 18 or higher than 35.
* Patients with a major psychiatric illness (e.g., major depressive disorder, schizophrenia, bipolar disorder)
* Patients diagnosed with another major dementia disease, including vascular dementia, Lewy Body disease, Huntington's disease, Creutzfeldt-Jakob disease, and Parkinson's disease.
Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)

The goal of this study is to evaluate the safety and efficacy of LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103 to evaluate its safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.
3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

Exclusion Criteria:

1. Any eye with disease that would interfere with the fundus examinations.
2. The study eye is receiving topical carbonic anhydrase inhibitor, or has received topical carbonic anhydrase inhibitors in the past three months.
3. The study eye has undergone intraocular surgery within six months prior to enrollment.
4. Participant has uncontrolled hypertension or diabetes.
Comparison of Constraint-Induced Movement Therapy And Bimanual Intensive Therapy Through Tele-rehabilitation For CP

Cerebral palsy is a neurological condition affecting movement and posture, caused by non-progressive brain disruptions occurring during fetal development. Constraint-induced movement therapy (CIMT) significantly improves arm and hand function in children with hemiparetic cerebral palsy by using intensive therapy sessions and restricting the unaffected limb to develop new motor skills. Bimanual therapy involves using both hands repeatedly to perform functional tasks, rather than relying on just one hand. Tele-rehabilitation (TR) is an affordable method of providing remote rehabilitation services through telecommunication technologies like smartphones and media applications. The aim of the study is to compare the effectiveness of CIMT and bimanual therapy delivered via tele-rehabilitation for improving upper limb function in children with cerebral palsy.

This randomized clinical trial will be conducted at Mubarik Medical Complex, Sargodha, Pakistan, with a sample size of 65. Participants will be randomly allocated into two groups using an online randomization tool, Group A will receive constraint-induced movement therapy (CIMT) intervention for 60 minutes, and Group B will receive bimanual therapy intervention for 60 minutes. Each participant will undergo treatment for three days a week on alternate days for eight weeks.

Spasticity will be assessed by using the Modified Ashworth Scale. The Quality of Upper Extremity Skills Test (QUEST) will evaluate dissociated movement, grasp, protective extension, and weight bearing, while the Tele-Rehabilitation Satisfaction Survey (TeSS) is designed to evaluate the experiences and satisfaction levels of patients or caregivers who have participated in tele-rehabilitation programs. Measurements will be taken at baseline, 4th week, 8th week, and at 12th week after discontinuation of treatment. The data will be entered and assessed using SPSS 26. For between-group analysis of parametric data, the independent t-test will be used, while non-parametric data will be analyzed using the Mann-Whitney test. Within-group comparisons will be conducted using repeated measures ANOVA for parametric data and Friedman ANOVA for non-parametric data.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years.
* Children with hemiplegic cerebral palsy with mild to moderate hand involvement.
* Ability to extend wrist \&gt;20° and fingers at the metacarpophalangeal joints

  \&gt;10° from full flexion
* Demonstrated ability to follow instructions during screening and complete the testing.
* Spasticity does not exceed a score of 1 or 1+ on the Modified Ashworth Scale

Exclusion Criteria:

* Health problems unassociated with CP.
* Visual problems interfering with treatment.
* Active or unstable seizures.
* Orthopedic surgery on the more affected hand within the last year.
Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study

The aim of this study is to evaluate the concentrations of interleukin-2, interleukin-10, interferon-gamma, PD1+ lymphocytes, and the interleukin-10 receptor expression in malignant and benign effusions.

In this prospective trial, 80 patients with pleural effusions and indication for thoracocentesis, drainage, indwelling pleural catheter (IPC) management and/or video-assisted thoracoscopic surgery are enrolled. The pleural effusion will be examined for different cytokines, cytokine-receptors, PD1-lymphocytes and CD4+/CD25+/Foxp3+ regulatory T cell.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* radiologically confirmed pleural effusion with an indication for puncture, pleural drain insertion, or video-assisted thoracoscopy for diagnostic and/or therapeutic reasons
* Signed declaration of consent

Exclusion Criteria:

* Withdrawal or cessation of participation
Glenohumeral Cortisone Injection

The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.

THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.

Eligibility Criteria:
Inclusion Criteria:

1.18-90

2. Proximal Humerus Fracture

3. Decreased range of motion at 6 wk follow-up

4. Likely to be available for follow up for 26 wks

Exclusion Criteria:

1. Known drug allergy to kenalog or lidocaine
2. Unable to complete functional outcome
3. Pregnant Women
Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy

the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis.

This study was conducted on nine eligible patients who complained of OAF with odontogenic sinusitis. Oral fistulectomy was done with proper curettage. Then, EMMA was performed with simultaneous closure of the OAF by application of PRF membrane and covering it with an acrylic splint. Patients were clinically evaluated for closure of the OAF after 14th days postoperatively, relief of the symptoms, and assessment of the pain level. Also, measurement of the size of the bone defect with the aid of computed tomography (CT) preoperatively and 24th weeks postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1 - Adult patients between the ages of 20-60 years. 2- Patients who were suffering from chronic fistula that occurred after the extraction of upper posterior teeth

Exclusion Criteria:

1. patients who have any systemic disease that contraindicates any intervention under general anesthesia (e.g., coronary artery disease).
2. OAF that occurred as a result of other causes (e.g., cyst,and trauma)
On-Track Feasibility Study of a Rehabilitation System for Stroke Patients

Feasibility study of On-Track - a digital system for upper limb rehabilitation after stroke.

Population - stroke patients over 18 years old.

TITLE Feasibility study of On Track - a digital system for upper limb rehabilitation after stroke

DESIGN \& METHODS Mixed methods

Aims Assess the feasibility of 'On-Track' (a new arm rehabilitation system), for use by patients, and therapists in stroke rehabilitation services.

OUTCOME MEASURES Various. (including functional and self-reported measures)

POPULATION Stroke survivors, their family/carers, clinicians, professionals and lay people working with stroke survivors.

ELIGIBILITY Participants will be stroke survivors, relatives/carers of stroke survivors, frontline healthcare workers who treat stroke survivors, managers responsible for stroke service provision and lay people with an involvement in stroke care/delivery.

Participants will be over 18.

DURATION 1- 2 years

Eligibility Criteria:
Inclusion criteria:

* Adults (aged 18 or over).
* Stroke diagnosis less than 6 months previously (first or recurrent). Some participants will be recruited from an in-patient rehabilitation ward, hence the 6-month poststroke limit.
* Arm impairment of any type or level (including weakness-including dense hemiplegia, neglect and sensory deficits). This enables better understanding of which impairment level groups could benefit or not from using the intervention, especially considering the impact it may have on people's motivation regardless of their level of impairment.
* Ability to provide informed consent.
* Reliability to communicate (verbally or non-verbally) and understand English.
* Ability to read a predefined short message.

Exclusion criteria:

* Unstable medical condition.
* Self-reported 'severe' pain in the arm affected either at rest or during movement.
* Severe oedema in the arm affected by their stroke, judged by the consenting therapist.
* Known discharge plans to a hospital other than the recruitment site or residential care in less than 7 weeks (a small proportion of patients in in-patient rehab may be in hospital for up to 12 weeks).
* Participants who are unable to engage with the intervention for a period of more than 7 consecutive days will be reviewed in a case-by-case basis by the members of the team responsible for delivering the intervention to determine if study continuation is appropriate.
First Time in Man Trial for Friulimicin B

The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

Continued widespread use of antibiotics has promoted the spread of antibiotic resistance and has created an urgent need for antibacterial agents with no known cross resistance to other antibiotics available for humans. Friulimicin B has been shown to be highly active against a range of bacteria including such important pathogens such as methicillin resistant Staphylococcus aureus (MRSA), drug resistant Streptococcus pneumoniae and Glycopeptide resistant Enterococcus spp. These organisms are the causative agents in serious infections such as skin and soft tissue infections, pneumonia, bacteremia and endocarditis, complicated urinary tract infections, and osteomyelitis.

This study is the first use of Friulimicin B in man and will examine its safety and a preliminary study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy subjects
* 18-55 years of age
* In good health

Exclusion Criteria:

* Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.
Feasibility of a Diet Intervention for Juvenile Arthritis

Families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. Previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that what people eat changes their gut microbiome. The investigators want to study whether a certain diet - based on the principles of the Mediterranean Diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement.

Fifty-four participants in this study will change their diet for an 8-week period, and will have the option of remaining on the diet for an additional 4 weeks. At three time points during the study (beginning, 8 weeks, and 12 weeks), participants will provide stool and blood samples, will complete questionnaires about diet and other aspects of lifestyle and health, and will complete a disease assessment by a clinician. From collecting all these samples and information, the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well.

This study will help the investigators figure out if a larger, and more definitive, study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis. If successful, this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic.


Eligibility Criteria:
Inclusion Criteria:

* Ages 8-18 years
* Diagnosis of JIA (excluding systemic JIA, enthesitis-related arthritis, and rheumatoid factor (RF) positive polyarthritis) as per International League of Associations for Rheumatology (ILAR) criteria. (For this feasibility study, there will be no requirement for any particular level of disease activity.)
* Subjects on stable treatment - i.e., any medical treatment with disease-modifying antirheumatic drugs (DMARDs) and/or systemic or intraarticular corticosteroids, has been unchanged for 8 weeks, and is unlikely to change for 12 weeks as judged by the treating physician.
* Willingness to provide stool samples.
* English or French fluency adequate to answer the study questionnaires, and participate in diet instruction, as judged by the enrolling physician.

Exclusion Criteria:

* Documented specific food allergies, celiac disease.
* Co-morbidities that might impact the tolerability of the study diet, e.g., type I diabetes, peptic ulcer disease, etc.
A Retrospective Study of C-kit Mutation Status in Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib.

Imatinib is the current standard treatment for advanced GIST. Previous studies have shown that GIST genotype was associated with treatment outcomes with exon 11 having superior outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response rate was higher at when imatinib was given at 800mg daily compared with the standard dose of 400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response in metastatic GISTs is intriguing, more information is needed before mutation testing is adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate, overall survival does not appear to be better with high-dose therapy. The investigators propose to conduct a retrospective analysis of mutational analysis on patients with GIST and determine the relationship between patient response and imatinib dose.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of advanced stage or metastatic GIST
2. Asian patient (as defined by the investigator)
3. First line treatment with imatinib
4. Availability of tumor samples for kit mutation analysis
5. Availability of tumor response rate and or time to progression data

Exclusion Criteria:

-
Patient Experiences in Rheumatology

Information was entered by mistake by a Research Assistant. Study never went beyond the initial discussion phase.


Eligibility Criteria:
All adult patients who have an appointment scheduled at the Rheumatology Clinic at Good Samaritan Hospital, can speak and read English and are willing and capable of providing informed consent are eligible to participate. All fellows in the Rheumatology Fellowship training program will participate.
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants

The purpose of this study is to assess the potential effects of ketoconazole on the pharmacokinetics of ibrutinib in healthy participants.

This is a single-center, open-label (all people know the identity of the intervention), sequential design study in healthy men. All participants will receive ibrutinib on Day 1 and ibrutinib in combination with ketoconazole on Day 7. Food will be restricted from the evening before dosing until 4 hours after dosing on Days 1 and 7. Following an overnight fast, ketoconazole will be given on Days 4 to 6, 1 hour prior to ibrutinib dosing on Day 7, and again on Days 8 and 9. All ibrutinib and ketoconazole doses will be administered with water. The participants will leave the study center on Day 10.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 30 kg/m2, and body weight not less than 50 kg
* Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* Non-smoker
* Must agree to use an adequate contraception method during the study and minimally 3 months after the last dose of ibrutinib, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Signed an informed consent document

Exclusion Criteria:

* History of or current clinically significant medical illness
* Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)
* Clinically significant abnormal values for laboratorial tests
* Use of any prescription or nonprescription medication, except for acetaminophen, within 3 days before the first dose of the study drug is schedule
* History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 2 years
Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children

The standard treatment for children with closed reduction of displaced distal forearm fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm immobilization with combicast in children 4-16 years might be sufficient.

Children with distal radial or forearm fractures needing closed reduction are eligible for this study. By drawing lots either an immobilization with an upper arm or forearm combicast will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be performed to check the rate of displacement, consolidation time, wearing comfort and movement of the elbow joint after taking off the cast.

Eligibility Criteria:
Inclusion Criteria:

* open growth Zone
* displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction
* written informed consent

Exclusion Criteria:

* intraarticular fractures
* open fractures
* unstable fractures