cyrilzakka/clinical-trials huggingface dataset:
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.

This study consists of a screening period followed by a placebo-controlled treatment period and then an extension treatment period and completed after a follow-up period after the completion of active treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg
2. Subject has a diagnosis of atopic dermatitis for at least 1 year.
3. Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4
4. Subject has a recent history (within 6 months before the screening visit) of inadequate response or inability to tolerate topical AD treatments (TCS or TCI) or who have required systemic treatments for control of their disease.
5. Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).

Exclusion Criteria:

1. Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
2. Have received certain treatments that are contraindicated.
3. Subject currently has been diagnosed and has active forms of other inflammatory skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with the evaluation of atopic dermatitis or response to treatment.
4. Other active non-AD inflammatory skin diseases or conditions affecting skin
5. Subject with active/severe concomitant disease (s)/symptom(s) that requires administering of systemic corticosteroids or otherwise interferes with study participation or requires active frequent monitoring (e.g., unstable chronic asthma).
6. Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation.
7. Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
8. Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
9. Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
10. Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.
11. Subject has a previously received systemic JAK inhibitors
12. Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care

The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.


Eligibility Criteria:
Inclusion:

* Any individual who is physically able to take a virtual reality visual field test
* Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma, or have other visual field defects, and normal individual
* Age: Individuals who are old enough to comprehend the instructions and procedures (1-90)

Exclusion:

* Adults unable to consent, prisoners
* Participants who are too tired to take a visual field test
* Participants who refuse to consent
* Individuals who are functionally unable to use VRVF
The Effects of Myofascial Release Technique

This study is designed as a single blind randomized controlled trial. Thirty-six elderly with non-specific low back pain (NSLBP) will be recruited. The participants will randomly divided two parallel groups as control and intervention. Traditional physiotherapy methods will be applied to all participants. Traditional physiotherapy will include heat modality (a hot pack for 15 minutes), electrotherapy (transcutaneous electrical nerve stimulation (TENS), a 50 Hz conventional TENS with a pulse duration \<150 microseconds). For the control group, core stability exercise will be applied 3 days/week, 6 weeks. For the intervention group, in addition to the core stabilization exercises myofascial relaxation technique will be performed with roller massager ((Thera-Band; The Hygenic Corporation, Akron, OH) 3 days/week, 6 weeks. The myofascial relaxation technique will be performed along the superficial back line. To the best of our knowledge, there is no randomized controlled study investigating the effect of the myofascial release technique combined with core stabilization in elderly with NSLBP. This study aimed to investigate the myofascial release technique combined with core stabilization exercise in elderly with NSLBP.

Low back pain is a symptom that is an important health problem throughout the world. Non-specific low back pain (NSLBP) is the most widespread form of the low back pain. The NSLBP is called low back pain without recognisable specific underlying pathology. The lifetime prevalence of low back pain is up to 84%. The prevalence and burden the low back pain of increases with aging.

The use of various methods of non-pharmacological and non-invasive especially exercise, mobilization, and manipulation in low back pain. Core stability exercise is a common exercise modality in the treatment of low back pain. Core stability exercises improve trunk strength and low back disability in elderly with NSLBP. However, the studies have showed that decreasing strength in the deep muscles (such as the transverse abdominis and multifidus) is accompanied by increased activation in the superficial muscles (such as the erector spina) in patients with low back pain. Therefore, myofascial release technique on superficial muscles can be effective in NSLBP.

To the best of our knowledge, there is no randomized controlled study investigating the effect of the myofascial release technique combined with core stabilization in elderly with NSLBP. Therefore, this study aimed to investigate the myofascial release technique combined with core stabilization exercise in elderly with NSLBP.

Eligibility Criteria:
Inclusion Criteria:

* Ongoing low back pain for at least 3 months
* Having no neurological, rheumatological or musculoskeletal problems
* Standardized Mini-Mental State score greater than or equal to 24 points

Exclusion Criteria:

* Low back pain originating from various pathologies
* Presence of cord compression,
* Radiculopathy,
* Osteoporosis or osteopenia (t score\>-1),
* Long-term use of anticoagulant or corticosteroid drugs,
* Patients who had received any treatment for their low back pain.
Docetaxel in Treating Patients With Advanced Cancer of the Cervix

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with advanced cancer of the cervix.

OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor response, toxic effect, and survival rate of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3 weeks for 3 courses. Patients are followed every 3 months posttreatment.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer

PRIOR CONCURRENT THERAPY: Not specified
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to Sjögren's Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or a female aged ≥ 18 years
* Have given their written consent to participate in the study
* Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection
* Willing to not use AT or autologous serum for the study duration
* VAS scale for Dry Eye Symptom Score ≥ 40
* Total CFS ≥ 5
* Schirmer's test with anesthesia \< 10 mm/5min
* Patients with Sjögren Syndrome

Exclusion Criteria:

* Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study
* Use of contact lenses during the study
* Significant Eye diseases according to investigator's opinion
Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery

Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of cochlear implants, for patients with Advanced Bionics devices.

The sound recordings created may be useful in aiding the surgeon to better implant the patient by letting him or her know if they are damaging the ear during implantation in real time

Patients will be followed up for 1 year post surgery within our trial, and have a further 3 ECochGs performed in the clinic setting, (6 weeks, 6 months, 1 year) through their implants.

Cochlear implant candidature has changed in the past years. Today many cochlear implant recipients have some low frequency residual hearing in the ear which is to be implanted. To help preserve hearing, the electrode array must be inserted extremely carefully. It is desirable to have real-time feedback relating to progress of the electrode insertion.

One possible tool that might provide this is an electrocochleography (ECochG). A brief low-frequency acoustic tone at a fixed level is delivered to the external ear canal. This results in normal movements of the outer and the inner hair cells inside the inner ear. These movements are known to produce small electrical potentials that have been previously been sensed by a recording electrode placed on the promontory, or surface of the bone in which the cochlea is located. Averaging of these recordings in synchrony with the acoustic stimulus allows the small ECochG signal to be reinforced while any physiological or electrical noise is averaged out. With ECochG measurements different aspects of the auditory system can be tested. For the investigators work only the cochlear microphonic, generated by the outer hair cells will be recorded and analysed.

The Advanced Bionics (AB) implant system is uniquely suited to do such measurements. The aim of the study is to monitor electrode array insertion during surgery and any residual hearing function over time in using this tool as a comparison to conventional methods. Subjects will undergo the study procedure of ECochG measurements, alongside additional standard of care appointments for the research, pure tone audiometry and impedence measurement. Only a 10 minute ECochG measurement will be the additional research component to the patients clinical routine as mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Patients between ages of 12 months to 6 years old, and Adults over 18 years old
* Meets normal candidacy requirements for cochlear implantation
* Advanced Bionics (AB) implant has been selected for patient at MDT
* Patient has capacity to consent
* Patent cochlea as verified by CT or MRI scan
* No cochlear abnormality that might prevent insertion of the electrode array
* Measurable residual hearing in the ear to be implanted
* No additional handicap that would prevent study procedures being followed
* Agreement to participate in the study

Exclusion Criteria:

* Complex cases where minimal duration of surgery is required. Although ECochG adds less than 10 minutes to the surgery time.
* Patients lacking the capacity to consent
Efficacy of Fractional Carbon Dioxide Laser Combined With Platelet-rich Plasma

This study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum Filipino women.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum patients with ages 18 to 45 years
* Fitzpatrick skin type III-V
* having bilateral symmetrical SG of red, white or a combination of both types.

Exclusion Criteria:

* pregnancy
* breastfeeding
* heavy consumption of alcoholic beverages
* dermatological conditions such as psoriasis, systemic lupus erythematosus and atopic dermatitis
* uncontrolled hypertension, diabetes mellitus, heart disease, acute and chronic liver/kidney impairment/disease;
* elevated liver function tests (SGPT, SGOT), and serum creatinine;
* intake of any medications that may influence the outcome of the study;
* intake of any vitamins/minerals or any supplements in the past 6 months; and
* application of any topical agents (e.g., whitening, anti-aging) in the past 6 months
Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children

Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group Results:

Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy Patient and Methods: The prospective study was conducted at Pediatric Surgery Department, Al-Azhar university hospitals, Cairo, Egypt . The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group

Eligibility Criteria:
Inclusion Criteria:

Children with persistant complete Rectal Prolapse.

* Failure of conservative treatment.
* more than 2 attacks of prolapse requiring manual reduction.

Exclusion Criteria:

* Sever constipation
* Previous abdominal or pelvic surgery with extensive adhesions.
* Cases older than 12ys,
* Patients with rectal polyp
Assessment of Nutritional Knowledge, Habits, and Eating Behavior in Athletic Women to Evaluate the Possible Impact on Their Menstrual Function

The present study aims to investigate the degree of knowledge about nutrition and dietary habits in athletic women through validated questionnaires and to evaluate a possible impact on their menstrual function, including women with a diagnosis of functional hypothalamic amenorrhea (FHA) and women who present with a different menstrual dysfunction (oligomenorrhea or polymenorrhea in absence of organic causes).


Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age 16-30 years
* Physical activity \> 2 days per week
* Informed consent from the patient and/or an authorized legal representative

Exclusion Criteria:

* Menstrual disorders of organic cause (ovarian cysts, uterine fibroids, polyps, etc.)
* Concomitant non-reproductive organic diseases (hypertension, diabetes, etc.)
* Use of psychopharmacological therapies
* Language barrier
Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture

To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture.

Twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group I was a patient with zirconia copy, and group II was with cobalt chromium CoCr copy. The PEEK was constructed for both groups as a secondary coping telescopic attachment for the denture. The wear measurements of PEEK were performed optically by using a USB digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. The data was statistically analyzed and compared using student t-test, ANOVA, and Post Hoc Test.

Eligibility Criteria:
Inclusion Criteria:

* completely edentulous
* free from any dental or systemic diseases

Exclusion Criteria:

* medically ill fit patient
* female patient
Pilot of a New Cognitive Assessment Tool for Detecting Dementia in the Migrant Somali Population

Aims

* The investigators want to find out if the tool that they have made to assess memory and thinking in Somali elders ( the 'MSCAT') is acceptable to that community and practical to administer and score.
* The public will benefit from this research because it seeks to enhance reliability of diagnosis of dementia, thus access to support and treatment for people from an ethnic minority group experiencing memory problems.

Background

* The investigators are a group of staff from the Memory Assessment Service in Manchester. There are currently no suitable tests for dementia for people from Somalia.
* Research evidence tells us there are many reasons why the tools that used now are not working. This includes: differences in culture and ways of life that are very different to a British born person who has lived in the UK for all of their life.
* Somali people find out at a later stage if they have dementia resulting in delayed treatment/support.
* This research supports the government's promise to improve the pathway to a diagnosis of dementia for minority groups.

Design and methods

* 10 participants
* The investigators will compare the assessment tool (MSCAT) that the team have developed to the Addenbrookes Cognitive Examination III tool that is typically used.
* Participants will be seen at an agreed location (e.g. home, mosque or GMMH trust site). They will meet a Somali speaking researcher to do both tests on 2 appointments and discuss how they found the tests afterwards.
* The investigators will check participants understanding of the research before they agree to take part. Verbal and written information will be provided.

Public involvement

* The local Somali community helped advise on the creation of the new MSCAT assessment tool.
* The investigators will write project information for participants in Somali and English.

Dissemination of results

• Professional conference presentations and publications


Eligibility Criteria:
Inclusion Criteria:

* The participants will all be Somali-born migrants, over the age of 50, living in the UK.

Exclusion Criteria:

* Exclusion criteria will include the presence of dementia, current delirium, or inability to complete the tasks due to visual/hearing/physical impairment
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
* MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
* Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
* Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

Exclusion Criteria:

* Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia. - Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
* History or evidence of clinically significant brain disease other than AD.
* Females who are pregnant or breastfeeding, or planning to conceive within the study period.
* Any experimental vaccine or gene therapy.
* History of unresolved cancer.
* Current use of anticoagulant medications.
* Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
* Participant is positive for presence of APOE e4/e4 genotype.
Hypertension Longitudinal Data Platform in Tianjin

Hypertension is one of the leading causes of death globally, and ranks among the top four risk factors for mortality and DALYs in China. However, large-scale population based longitudinal research data source for hypertension is lacking in China. Thus, we aimed to establish the first and most extensive hypertension database in China using healthcare data from the Tianjin city. This hypertension longitudinal data platformlinked electronic medical records (EMR) system 35 stores healthcare data of 1.17 million hypertension patients, from 43 tertiary hospitals and 39 secondary hospitals, along with a public health follow-up management system. Data on demographics, diagnosis, drug prescription, laboratory test, physical examination, and cost information were collected, the median follow-up time was 4.3 \[ interquartile range (IQR): 2.7-5.8\] years, and the median number of outpatient visits was 32 (IQR: 15-64) per patient. This database can address research needs including, drug utilization pattern analysis, policy implementation evaluation, digital medical device development, and other real world evidence studies. These researches would provide robust evidence to assist improving patient health outcomes and healthcare system decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension first diagnosed between January 1, 2015 and December 31, 2021
* Aged 18 years or older

Exclusion Criteria:

* None