cyrilzakka/clinical-trials huggingface dataset:
Early and Longitudinal Assessment of Neurodegeneration in the Brain and Spinal Cord in Friedreich's Ataxia

Friedreich's ataxia is characterized by progressive alterations in the function of the cerebellum accompanied by an atrophy of the spinal cord. Although the genetic defect responsible for the disease has been identified more than 15 years ago, objective markers of the pathologic process (i.e., biomarkers) that would allow measuring the effects of potential therapies are still lacking. Moreover, it is still unclear how the malfunction of the cerebellum affects the rest of the brain, and understanding the connectivity and neurochemistry of the central nervous system might yield new insights in the understanding of the disease, in addition to providing potential markers.

To address these needs, the investigators aim at utilizing the capabilities of Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS). Using techniques called Diffusion Imaging, resting-state functional MRI, and Proton Spectroscopy (1H MRS), the investigators propose to determine the differences in the connectivity and neurochemistry of the spinal cord and the brain between patients affected by Friedreich's ataxia and healthy controls. The investigators plan on imaging both patients and control subjects using a 3T magnet, a system that although not yet available in all medical facilities, is becoming standard in most hospitals and clinics. The first aim is to scan patients already scanned last year (12-month follow-up). The second aim is to scan patients at an early stage of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of Friedreich's ataxia for patient volunteers with GAA repeat expansion number
* Absence of neurological conditions for control volunteers
* Control volunteers will be age-, race-, and gender-matched to the patients

Exclusion Criteria:

* Claustrophobia
* Smoking
* Diabetes
* Pregnancy or lactation
* Weight over 300 lbs
* Presence of a pacemaker or any paramagnetic object in the body
* Severe scoliosis
Comparative Analysis of Mulligan and Maitland Mobilizations Techniques in Adhesive Capsulitis

Mobilization techniques are widely used in physiotherapy to address the pain and stiffness associated with adhesive capsulitis. Two commonly employed approaches are Mulligan's mobilization and Maitland's mobilization, both of which aim to restore joint mobility and improve functional outcomes. However, the relative effectiveness of these techniques in improving disability and quality of life in patients with adhesive capsulitis has not been conclusively established. This study will help to find out the best mobilization option for adhesive capsulitis or frozen shoulder for all four stages of adhesive capsulitis.

Adhesive capsulitis is a condition characterized by pain, loss of both active and passive range motion of the shoulder joint in all planes especially abduction and external rotation. In general population the prevalence of adhesive capsulitis is 2-5% and its incidence is 2%.The prevalence of adhesive capsulitis in diabetic patient is 11- 30% while in non-diabetic is 2-10%.Adhesive capsulitis is more common in women aged between 40-60 years (12). Adhesive capsulitis is bilateral in 20-30 % of cases and the opponent shoulder become involved within five years Based on etiology Adhesive capsulitis is classified into primary or true frozen shoulder and secondary, in primary adhesive capsulitis there is global capsular inflammation without any known cause or pre-existing condition while secondary adhesive capsulitis is associated with any recognized systemic, intrinsic or extrinsic cause. The systemic causes of secondary adhesive capsulitis comprise thyroid diseases, diabetes mellitus and decreased level of adrenaline. The intrinsic cause of secondary adhesive capsulitis is rotator cuff disease andcalcification of tendon or tendonitis. The extrinsic causes of secondary adhesive capsulitis include breast surgery in women, post trauma, clavicle or humerus fracture and early history of cerebral vascular accident

Eligibility Criteria:
Inclusion Criteria:

* Age 35-50 years.
* Diagnosed case of primary adhesive capsulitis.
* Pain and limited range of motion in the affected shoulder. (External rotation\>abduction\>internal rotation)
* Willing to participate in the study

Exclusion Criteria:

* Previous shoulder surgery.
* Severe osteoporosis or fractures.
* Neurological or rheumatological conditions.
* Neck and cardiac surgery
* History of recent fractures
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
* Ability to comply with the study protocol, in the investigator's judgment
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment
* Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

* Uncontrolled blood pressure, defined as systolic blood pressure \>180 millimeters of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while a patient is at rest on Day 1
* Pregnancy or breastfeeding, or intention to become pregnant during the study
* CNV due to causes other than AMD in the study eye
* Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
* Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
* Uncontrolled glaucoma in the study eye
* Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
* Prior IVT administration of faricimab in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active ocular inflammation or suspected or active ocular or periocular infection in either eye
* Other protocol-specified exclusion criteria may apply
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy

The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.

The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy based on subject incidence of adverse events.

The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Key Inclusion Criteria:

* Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association \[ADA\] criteria)
* Residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening (Albumin:creatinine ratio \[ACR\] of 100 to 3000 mg/g creatinine, inclusive)
* Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease \[MDRD\] equation) of ≥ 25 mL/min/1.73 m(2)
* Must be on a stable dose of an ACE inhibitor or ARB for at least 8 weeks prior to screening, but subjects must not be on both an ACE inhibitor and an ARB
* Hemoglobin A1c (HbA1c) \> 6.0% but not \> 10.0% and fasting plasma glucose less than 270 mg/dL at screening

Key Exclusion Criteria:

* Type 1 diabetes mellitus or history of diabetic ketoacidosis
* Previous renal transplant or known non-diabetic renal disease, except related to hypertension
* Undergone renal dialysis at any time in the past
* Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
* Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
* Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
* Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
* Poorly-controlled blood pressure (systolic blood pressure \>155 or diastolic blood pressure \>95, with blood pressure measured in the seated position after at least 5 minutes of rest)
The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection

Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why some aortic dissection are limited in extent while other aortic dissection extend extensively. The investigators hypothesize that the medial layers are separated as a result of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis is ture, dilation is necessary to the development of aortic dissection. In this study, an in vitro experiment was performed to test whether dilation is essential to the development of aortic dissection.

Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation. Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly, the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of the experimental group was bound by a band to restrict its dilation in the next step. Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly, for the experimental group, the band is removed, and the syringe is filled with red stain. The mechanical test is performed again. Finally, the tissue sheet is released and cut into several parts to show whether the inner and outer media layers are separated by the blue stain or the red stain.

The mechanical test: the syringe's pressure will increase gradually to a target level, and then decrease gradually to 0 Mpa, and this process is repeated for about 60 times.

Eligibility Criteria:
Inclusion Criteria:

* patients with aortic repair surgery.

Exclusion Criteria:

* the dissected aortic wall is not big enough to be cut into a 2cm by 2cm sheet after routine pathological examination.
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Olanzapine Orally Disintegrating 5mg Tablets Under Fed Condition

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a washout period during fed study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Controlled Propofol Administration

The purpose of this study is to compare the administration of the standard anesthetic agent (propofol) using this automatic system with the manual administration of propofol by the anesthesiologist.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 to 90 years
* surgery lasting more than 30 min

Exclusion Criteria:

* inability to provide informed consent
* allergies to study drug
Is Analgesic Effect of Low Dose Ketamine-midazolam the Same as Morphine

the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on pain control in trauma patients with closed limb fracture(s); and also compared the incidence of adverse events (mainly cardio pulmonary ) between two groups.

this prospective, single blind, noninferiority trial randomized consecutive ED patients aged 18 to 60 years to two groups: receiving either 300-500 mcg ketamine plus 0.03 mg midazolam, or 0.05 to 0.1 mg morphine. Visual analogue score and adverse events were carefully verified during an interval of 30 minutes.

Two hundreds, thirty six patients were selected, among whom were 207 males (87.3%), and 29 females (12.2%). The average age was 29±2, with extremes of 60 years and 18 years.the patients were divided into two groups: G1: 116 patients receiving ketamine-midazolam and G2: 120 patients receiving morphine alone.

Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 60 years
2. Patients with closed limb fracture(s)
3. VAS score of at least 6

Exclusion Criteria:

1. Acute pulmonary infection
2. Previous coronary artery diseases,ACS,congestive heart failure,
3. suspected aortic dissection
4. History of uncontrolled hypertention or blood pressure \> 140/90mmHg
5. Brain injury with focal neurological deficit or loss of consciousness
6. Central nervous system mass lesion,hydrocephalus, or other states with increased intracranial pressure
7. Glaucoma and acute globe injury
8. History of porphyria
9. Previous hyperthyroidism or thyroid hormone replacement
10. Pregnancy or laction
11. Major psychiatric disorder
12. Previous allergic reaction to the agents administered in the study
13. Patient declined to provide written informed conse
Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings

This study will record vital signs (heart rate and blood oxygen levels) using a new cell phone integrated biosensor and compare it to routine measurements carried out in the clinics and hospital at UCSD. Cell phones will be given to a selected group of subjects for use at home and data collected.

Maxim Vital Sign study is a 2 part, investigator initiated observational study with Maxim Integrated aimed to compare vital sign readings using 2 prototype versions of new cell phone based mobile biosensors with standard of care (SOC). Adult subjects will be recruited from UCSD outpatient clinics, AVRC clinic, emergency department (ED), and hospitals. Vital signs will be measured using cell phone based mobile biosensors and SOC.

For Phase 1, up to 800 subjects will be recruited (700 adults and up to 100 adolescents). 250 subjects (200 adults and up to 50 adolescents) will participate in phase 1a and 550 subjects (500 adults and up to 50 adolescents) will participate in phase 1b. An additional group of 30 adult subjects will be recruited from outpatient clinics for participation in phase 2.

Phase 1a:

Two identical copies of the device will be tested during the first part of phase 1 with a total of 125 subjects (100 adults and up to 25 adolescents). Each prototype version will be tested on up to 125 subjects (100 adults and 25 adolescents) and compared to readings obtained by Welch-Allyn Spot Vital Signs monitor. Data will be obtained on the usability and accuracy of the measurements with each initial prototype. Measurement particularly of SpO2 depends on accurate finger position. Current SpO2 monitors encase the finger and immobilize it in order to obtain an accurate measurement. Maxim Integrated, in collaboration with DD Studios, Carlsbad CA, and Specialists in Global Health, Encinitas CA, have developed prototypes, which will be tested to inform design flaws in future prototypes.

Phase 1b:

Based on the results from phase 1a, one of the prototypes will be selected for further testing (the one with the least within-instrument variation). During Phase 1b, vital sign readings will be collected with the selected Maxim biosensor prototype and one of the Welch-Allyn Spot Vital Signs monitor simultaneously. The subjects will be recruited from both outpatient and hospital settings for accuracy and usability. A total of 550 subjects (500 adults and 50 adolescents) will be recruited for this part of phase 1.

Eligibility Criteria:
Inclusion Criteria:

1. Children (≥ 13 years old) and adult male and female subjects who provide written informed consent and assent.
2. Subjects must be willing to use the mobile device and answer questions regarding their experience.

Exclusion Criteria:

Individuals with prior or recent injury to one or both of their index fingers that would prevent or interfere with the use of Maxim biosensor.
Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.

Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.


Eligibility Criteria:
Trial Stage Inclusion Criteria:

* At least 21 years of age
* Post-stroke shoulder pain

Trial Stage Exclusion Criteria:

* Use of habit-forming (narcotic) medications
* History of recurrent skin infections
* Bleeding disorder
* Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or complex regional pain syndrome
* Heart arrhythmia or artificial heart valves
* Uncontrolled seizures
* Implanted Electronic Device

Implant Stage Inclusion Criteria

* Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4
Upper Extremity Asymmetries in Overhead Athletes

Although overhead sports have different characteristics, the movements in the shoulder and upper extremity are similar. These sports may involve a combination of symmetrical, asymmetrical, bilateral and unilateral movements. In sports involving asymmetric movements, biomechanical changes are observed in that area due to the use of the dominant extremity. One of the reliable methods to reveal the stress effects caused by biomechanical stresses is to determine limb asymmetries. Considering the literature, limb asymmetries may be related to injury and performance.


Eligibility Criteria:
Inclusion Criteria:

* 15 years and older
* Attending regular sports training and competitions

Exclusion Criteria:

* Acute injury during tests