cyrilzakka/clinical-trials huggingface dataset:
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least

  1 year prior to Baseline
* Stable HS for at least 2 months prior to Screening and also at the Baseline Visit
* Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS
* Total abscess and inflammatory nodule count \>=3 at the Baseline Visit
* Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified over-the-counter topical antiseptics on their HS lesions
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
* Male subjects must be willing to use a method of contraception when sexually active, up till 20 weeks after the last administration of study medication

Exclusion Criteria:

* Prior treatment with anti-IL17s or participation in an anti-IL17 study
* Previously received anti-TNFs
* Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol)
* Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline Visit
* Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline Visit
* Draining fistula count \>20 at the Baseline Visit
* Diagnosis of inflammatory conditions other than HS
The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma

Spinal hemangioma is one of the most common benign vertebral tumours. Being mostly asymptomatic, it is still associated with a pain syndrome especially if encroaches into the neural canal.

This study is organised to evaluate the efficacy and safety of β-blockers drugs in adults with spinal hemangioma.


Eligibility Criteria:
Inclusion Criteria:

* vertebral hemangioma

Exclusion Criteria:

* symptomatic bradycardia
* AV block
* decompensated heart failure
* asthma
Efficacy and Tolerability of Flunarizine for the Treatment of Schizophrenia: Comparison With Haloperidol

Flunarizine is a calcium channel blocker traditionally used for the treatment of vertigo and migraine. It also has the mechanism of action associated with antipsychotic activity (D2 receptor blockade), but has never been tested as such. The investigators hypothesis is that flunarizine can be an atypical antipsychotic.

The main advantage of flunarizine over other D2 receptor blockers is its long half-life, so that it may be administered weekly or may delay relapse if medication is interrupted.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV schizophrenic or schizoaffective patients between 18 and 55 years old with a PANSS score above 45.

Exclusion Criteria:

* Clinical disease
* Pregnancy
* Drug dependence (except for nicotine) in the past month and history of being refractory to at least 2 antipsychotics taken appropriately.
Improving Dietary Protein Intake in Adults

A pilot, single-arm investigation used coaching, nutrition education, and a per-meal protein prescription to assess impact on protein intake, muscle strength and function in older adults.

Objective: To evaluate the effects of nutrition education, diet coaching, and a protein prescription (PP) on protein intake, and associations with muscle strength and function. Design: Prospective pretest posttest single-arm study. Setting: Urban area, East coast of South Florida. Participants: Older adults. Intervention: 10-week telephone-based diet coaching, nutrition education and a per-meal PP. Measurements: Protein and energy intakes, weight, grip strength (GS), and 5-chair-rise (5CR), timed up and go (TUG), 3-meter walk (3mW) tests at baseline and 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 55 years or older,
* Community-dwelling (living independently),
* Able to provide consent,
* Able to understand and respond to questions or instructions in English,
* Have a working telephone (for coaching sessions),
* Willingness to consume protein-containing animal products
* Willingness to make changes to the diet

Exclusion Criteria:

* Self-reported information that they have been told by a medical doctor that they have kidney (renal) disease.
* Vegan dietary practices,
* Refusal to make changes to usual dietary protein intake, or a usual dietary protein intake that meets recommendations.
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand

The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of active inflammatory, erosive osteoarthritis of the hand.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hand osteoarthritis
* Joint tenderness and/or redness
* At least one erosion by X-ray (as determined by the central reader)
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
* History of gout, pseudogout, or hemochromatosis
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Known allergy to acetaminophen
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply
Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis

A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.administered every 4 weeks for 56 weeks.

The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 160 adults with prurigo nodularis were scheduled to receive multiple subcutaneous injections (every 4 weeks for 56 weeks). The study was divided into a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a maintenance treatment period (24 weeks), and a follow-up period (8 weeks).

Eligibility Criteria:
eligibility criteria:

1. voluntarily sign the ICF and comply with all the visits and research-related procedures required by the protocol;
2. Both men and women were required to be ≥ 18 and ≤ 80 years old at the time of signing the informed consent;
3. the duration of PN diagnosed by a dermatologist at the time of screening was ≥ 3 months;
4. In the range of 1-10, WI-NRS≥7 in the past 24 h at screening; WI-NRS in the week before the baseline visit The average weekly score was ≥ 7 points.

Exclusion criteria：

1. There are skin diseases other than PN and mild atopic dermatitis (AD) that may interfere with the assessment of research outcomes.
2. Patients who had a history of moderate to severe AD during the 6 months prior to the screening visit or screening visit.
3. Receiving potent or super-potent TCS/TCI treatment within 2 weeks before or during screening.

4) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening
Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis

This is a pilot study that investigates the efficacy of video-assisted endoscopic sympathicotomy from the level of T3 to T12 on combined palmar and plantar hyperhidrosis.

Ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis in a single setting.

Eligibility Criteria:
Inclusion Criteria:

* patients with combined palmo-axillo-plantar hyperhidrosis of ASA grade I and II

Exclusion Criteria:

* Patients under 16 years.
* Patients with bradycardia (heart rate \<80 beats per minute).
* Patients with concomitant lung pathology, frozen mediastinum, pleural effusion, or history of intercostal tube insertion.
* Patients with cardiac problems with ejection fraction less than 60%.
* Patient suffering from isolated palmo-axillary hyperhidrosis not associated with plantar hyperhidrosis.
* Patients suffering from craniofacial hyperhidrosis, either isolated or combined with other areas of hyperhidrosis.
Role of Elastography in Diagnosis of Testicular Tumors

The aim of study is to differentiate between testicular tumors by their elastographic criteria (Stiffness \[hard to soft\] , Shape under compression , etc.) using ultrasound elastography techniques (shear wave/strain elastography) on suspected testicle that showed specific lesion on normal ultrasound examination.

Technique:

Using a linear ultrasound probe supporting elastography techniques, either :

Strain Elastography (SE) SE measures tissue stiffness by applying external tissue pressure \[3\]. Tissue dimensions change due to the applied pressure; this deformation is termed strain. Stiffer lesions deform less, and have correspondingly lower strain and higher Young's modulus.

In strain imaging, tissue displacement is calculated by processing radiofrequency (RF) datasets obtained before and after compression \[4\]. Translucent colored elastograms (strain images) can be superimposed on B-mode images to provide complementary anatomic information. It is common to display the strain map as colored pixels on a red/blue scale or gray scale \[5\].

Or Shear wave elastography (SWE) Shear wave elastography differs from strain elastography, as it is a quantitative method of assessing tissue elasticity by measuring the speed of acoustic radiation force impulse-induced shear waves traveling in the tissue of interest.

The compressive acoustic waves used for conventional B-mode image generation travel at high speeds through soft tissue (1450-1550 m/s). By contrast, mechanical shear waves used for shear wave elastography travel relatively slowly (1-10 m/s). Shear wave propagation velocity depends on tissue stiffness \[2, 4\].

Data collection:

Data will be recorded as excel spreadsheet and statistical analysis using SPSS software version 22

Computer software: SPSS version 22 statistical software.

Statistical tests: T-test.

Eligibility Criteria:
Inclusion Criteria:

* i. Age : (15-65 years).
* ii. Patient with history of testicular pain or discomfort or even without clinical symptoms.
* iii. Patient with any predisposing factors as mentioned before in the background.
* iv. Patient with history of cancer of other organs (not testicular tumors).

Exclusion Criteria:

* i. patient refused to be included in the study. ii. infarct correlation with patient history and symptoms is important. iii. Infections as focal orchitis. iv. History of trauma (hematoma exclusion).
Stimulus-response and Parkinson's Disease (SRlearning)

In a computerized experiment, visual stimuli will be presented to the parkinson's disease patients and to the controls. They will respond to each image by acting on the keyboard in a specific manner. Each participant will repeat that task 384 times per session. A break will be inserted every 12 tests so that participants can rest.

The experiment consists of three sessions. Each image will be presented three times. For the first two presentations it is assumed that a link will be created between the image and the task, and the image and action. In the third presentation, the same task and the same action will be maintained or will be swapped. In this way, It can be checked whether associations thus generated will affect the performance of the participants when tasks and actions will be incongruent.


Eligibility Criteria:
Inclusion Criteria:

* Patient : Parkinson's disease Controls: healthy volunteers paired to patients on sex and age group

Exclusion Criteria:

* Other neurological condition
* Known pregnancy or breastfeeding woman
* No medical insurance coverage
* Person under legal protection
Optimization of MRI for Radiation Therapy

Currently, appropriate patients undergo MRI imaging with immobilization and sequences optimized for diagnostic radiology purposes. Using a mutual information algorithm, these images are then registered to a treatment planning CT obtained with custom immobilization to minimize intra-and inter-treatment motion and positional variation. This image registration process is time-consuming and introduces additional layers of geometric uncertainty into what should be a highly precise treatment planning process. However, it is necessary, since radiation dose calculations cannot be performed on MRI data due to the lack of crucial density information. The investigator envisions CT-less treatment planning, using only MRI, due to superior imaging characteristics, fully integrated into the radiation oncology clinic. This study will begin this process.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age
* A working diagnosis of malignancy in the liver, brain, H\&N, or pelvis
* A plan to treat with radiotherapy

Exclusion Criteria:

* Patients with contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Radiology Department.
A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection


Eligibility Criteria:
Key Inclusion Criteria:

* Chronically infected with hepatitis C virus genotype 1
* Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or hepatitis B virus
* Hepatitis C virus RNA viral load of ≥ 10\*5\* IU/mL
* BMI 18 to 35 kg/m²

Key Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with hepatitis C virus infection
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
Trial of Sertraline to Treat Children With Fragile X Syndrome

This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2 years to 5 years 8 months old. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and a decrease in autistic symptoms.

This is a single center study and the UC Davis MIND Institute for fragile X syndrome (FXS) patients aged between 2 years and 5 years, 8 months old funded by the Health Resources and Services Administration (HRSA). It is a double-blind control trial of sertraline (Zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are investigating the use of this selective serotonin reuptake inhibitor (SSRI) in FXS because a retrospective study has shown significant improvements in language and decreases in autistic behavior. There is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development of animal models of Down syndrome. The researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors.

The aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with FXS who are between the ages of 2 years and 5 years, 8 months old. At baseline, the researchers will assess behavioral and cognitive development. These children will be treated for six months with either sertraline or placebo. At the end of the six months, the researchers assess the same behavioral and cognitive measures as at the beginning of the study. The researchers will also assess the side effects of the sertraline treatment throughout the study.

On March 14, 2017 two secondary outcomes for each of the primary outcomes were added for clarification of measurements at baseline visit and at six-month visit. In April 2017 additional updates were made to report primary and secondary outcome results. By June 2, 2017 all outstanding secondary outcome results had been added.

In July 2017, additional updates to the outcome measures and limitations sections were made to address PRS review comments. In the process of responding to these comments, a duplicate reported outcome measure was identified and deleted.

In August 2017, additional updates to the outcome measures were made to address PRS review comments issued in response to the July 2017 updates.

Eligibility Criteria:
Inclusion Criteria:

* Fragile X Syndrome

Exclusion Criteria:

* Current or past SSRI treatment
* Current or past MAOI (monoamine oxidase inhibitor ) treatment
* Serious co-morbid medical disorder affecting brain function and behavior (not including fragile X syndrome).
* Uncontrolled seizure disorder or epilepsy
* Bipolar disorder
* Latex allergies
Shoulder Proprioception: a Comparative Study on Hand Dominance and Sex

The goal of this cross-sectional study is to examine the differences in proprioception sensation depending on sex and dominant side factors in healthy volunteers. Hypothesises:

H0: Shoulder proprioception sensation does not change depending on sex and dominant side factors.

H1: Shoulder proprioception sensation varies depending on sex and dominant side factors.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have agreed to participate in the study after being provided with detailed information about the research will be included in the study.

Exclusion Criteria:

* Individuals who have undergone surgery or experienced trauma in the upper extremity, which impairs hand function, strength, and/or sensation, or who have a fracture or acute orthopedic injury within the last 6 months.
* Individuals with a history of neuromuscular disease, traumatic nerve injury, congenital anomaly, skin infections, or other conditions that could affect the assessment.
Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.


Eligibility Criteria:
Inclusion Criteria:

* In good general health, and postmenopausal for at least 5 years or more
* Diagnosed with postmenopausal osteoporosis
* Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis
* One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan)
* Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study

Exclusion Criteria:

* Evidence of metabolic bone disorder
* History of malignancy (cancer) for 5 years or less
* Active thyroid disease that cannot be managed with medication
* Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation)
* Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history

(within the last year) of drug or alcohol abuse or dependence

* Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®)
* Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)
Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.

Comparison of two asthma treatments by lung function measures.


Eligibility Criteria:
Inclusion criteria:

* Currently receiving 200-800mcg/day beclomethasone dipropionate.
* sRAW value of 1.3 kPa's.

Exclusion Criteria:

* 3 or more courses of oral steroids in last 12 months.
Falling Risks in Elderly Adults : a Prospective Cohort Study

Introduction: the prevalence of falls in adults aged 65 years or older living in the community is 30%, being the second cause of accidental fatal injury and the fifth cause of death. About 20 to 30% of falls result in injuries: 10% constitute serious injuries, from which 5% are fractures. As a result, older adults decrease their mobility, are afraid of falling depressed and socially isolated, increasing the risk of later falls, death and health costs. Falls and their consequences can be prevented, so knowing and assessing the demographic, medical, self-perceived and functional characteristics constitutes an important information for health professionals. Given the high rate (29.59%) of older adults treated at the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni" and the relevance of falls in this population, it is convenient to take a behavior and start by knowing their risk characteristics.

Objectives: to determine the incidence of falls of adults aged 65 years and older, seen in the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni"; to describe the characteristics of these population and to identify the potential risk-of-falling factors.

Subjects and Methods: observational, prospective, longitudinal cohort study. Demographic (age and sex), medical (history of falls, visual alterations, medication and walking aids), self-perceived (fear of falling and instability perception) and functional characteristics (Test of Timed up and Go, Dynamic Index of gait and balance tests) will be evaluated in those patients of 65 years or more who initiate physical treatment in the outpatient consult of the of the "Hospital Francisco Santojanni" "Autonomous City of Buenos Aires, from March 2017 to February 2018, with a follow-up of 6 months until August 2018, to verify the development of the fall event


Eligibility Criteria:
Inclusion Criteria:

* Patients of 65 years or more treated at the Physical Therapy outpatient consult of the " Hospital Francisco Santojanni" that they walk at least inside their home and have signed informed consent

Exclusion Criteria:

* patients who walk with partial body weight load
* patients using a lower limb immobilization device