cyrilzakka/clinical-trials huggingface dataset:
Clinical Assessment of All Ceramic Single-retainer Using Upper Canine as Abutment With Minimum Preparation on the Lingual Surface, to Replace the Upper Lateral Incisor and Will be Compared With the All Ceramic Single-retainer Using Upper Central Incisor.

The Intervention Will be All Ceramic Single-retainer Resin Bonded Fixed Partial Denture Using the Upper Canine as Abutment With Minimum Preparation on the Lingual Surface Within the Enamel Providing Maximum Area for the Retainer Bonding, to Replace the Upper Lateral Incisor and Will be Compared With the Control/Comparator Group Which is the All Ceramic Single-retainer RBFPD Using the Upper Central Incisor. The Participants in This Study Will be Recruited by the Researcher From the Clinic of Fixed Prosthodontics Department, Clinic of Orthodontics Department and Clinic of Diagnosis Department, Cairo University Without Any Financial or Non-financial Incentives.

The intervention will be all ceramic single-retainer Resin Bonded Fixed Partial Denture using the upper canine as abutment with minimum preparation on the lingual surface within the enamel providing maximum area for the retainer bonding, to replace the upper lateral incisor and will be compared with the control/comparator group which is the all ceramic single-retainer RBFPD using the upper central incisor.

This intervention will be done by one investigator in all study groups who has master degree in fixed prosthodontics with eight years of experience. The intervention will be carried out in the clinic of the department of Fixed Prosthodontics, Cairo University under supervision of PhD holder staff members. The self-adhesive dual cure resin cement will be used for cementation in all groups.

In the first session, the participant will be informed about all steps from the beginning to the end. All participants will be encouraged to maintain good oral hygiene and attend the regular follow up visits and in case of any complain related to the investigated restoration.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have unilateral or bilateral missing upper lateral incisor and need to replace them with the following criteria:
* From 14-30 years old and be able to read and sign the informed consent document.
* physically and psychologically able to withstand conventional dental procedure
* Sound or minimally restored abutment with enough enamel surface area for bonding and no periodontal diseases.
* If the patient had previously undergone orthodontic treatment, a stabilization period of at least 3 months before impression taking.
* Good oral hygiene.
* Able to return for follow-up examinations and evaluation.
* No signs and symptoms of bruxism.

Exclusion Criteria:

* Pregnant women
* Increased overbite
* Bruxism, clenching or abnormal habits like nail or pencil biting that create occlusal forces
* Any developmental anomaly affecting the enamel of upper central incisor or canine
* Uncontrolled caries and periodontal disease and uncooperative patients. 6- Medically unfit for dental treatment and follow up.
Clinical and Molecular Correlations in Spinocerebellar Ataxia Type 10 (SCA10)

OBJECTIVES: I. Clinically evaluate members from families with a dominantly inherited ataxia and collect blood, skin and muscle samples for detailed molecular studies.

II. Perform detailed clinical evaluations on patients with recessively inherited ataxias.

PROTOCOL OUTLINE: Participants undergo a comprehensive clinical and molecular evaluation. Studies include: neurologic evaluation, including magnetic resonance imaging and nerve conduction studies; ophthalmologic exam; audiologic exam, including auditory brain stem evoked response; DNA extraction from blood, skin and muscle; genotype phenotype correlation.

A neuropathologic evaluation is conducted postmortem, when possible.

Eligibility Criteria:
Inclusion criteria:

Subjects who have the diagnosis of SCA10 and their immediate relatives.

Exclusion criteria:

Children under 3 years of age, pregnant women, prisoners, mentally incapacitated subjects, and subjects who do not give consent.
Intranasal Delivery of Testosterone and Its Effect on Doping Markers

Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic profile during anti-doping testing, which is different than the profile seen when testosterone is administered into muscle, on skin or under the tongue.

Objective: The investigators aim to characterize the unique steroid doping profile following administration of intranasal testosterone to healthy, active volunteer subjects.

Testosterone is a substance commonly abused in the sporting world despite being banned by all American sports leagues, international federations, and the World Anti-Doping Agency. Current methods employed to detect exogenously administered testosterone include direct detection using isotope ratio mass spectrometry (IRMS) and indirect detection using the athlete biological passport (ABP). However, different formulations of testosterone (oral, transdermal, sublingual, etc) are expected to result in characteristic IRMS profiles, affect the ABP readings in unique ways, and differ in their windows of detection. In 2014, a new formulation of testosterone, Natesto, which is administered intranasally, was FDA approved. Though only approved for medical use, it is expected athletes may use this product, and its effect on steroid doping markers has yet to be determined. Characterization of this detection profile is necessary for confirmation of the exact product being administered in an anti-doping setting. In this study, the investigators aim to understand the effects on the steroid doping profile following a single administration of Natesto to healthy, active volunteers. Windows of detection will be determined for the standard dosing of Natesto, and the effects on ABP markers and IRMS profiles will also be established.

Eligibility Criteria:
Inclusion Criteria:

1. Males between the ages of 18 and 35 years-old who participate in regular, moderate to high intensity physical activity will be recruited for the study.

Exclusion Criteria:

1. Individuals below the age of 18 or greater than the age of 35 on the day of enrollment
2. Individuals who are in a Registered Testing Pool for anti-doping purposes, or individuals who for any reason could be subject to doping control testing.
3. Unwilling to provide blood or urine samples
4. Not actively exercising
5. Individuals with any history of cancer, cardiovascular disease, endocrine abnormalities, renal disease, hepatic disease, neurologic disease or any psychiatric history
6. Individuals with a history of nasal disorders, nasal surgeries, sinus surgeries, or sinus disease
7. Individuals that have a baseline hematocrit value above the normal range
8. Individuals that are diabetic or are currently taking a diabetic medication
9. Individuals that are currently using any WADA prohibited substances
10. Individuals that have recently used or currently using anabolic androgenic steroids
To Explore Cognitive Neural Mechanism of Autoimmune Encephalitis by Using Neuropsychological Tests and Multi-modal MRI

Most of patients with autoimmune encephalitis are left with permanent cognitive deficits of varying severity. The patients' life and career would be affected definitely by cognitive deficits. Recently, more and more clinical physician have begun to focus on cognitive impairment of patients with autoimmune encephalitis. Generally, the outcome was measured by the modified Rankin Scale (mRS). However, the mRS are commonly used to evaluate the degree of disability or dependence in the daily activities of the patients suffering from a stroke and cognition function were minimally evaluated in this scale. It is crucial to adopt detailed cognition tools to study the long-term cognitive outcomes and as an indicator of overall curative effect judgment in autoimmune encephalitis.

Currently, only early immunotherapy is uniformly and consistently considered to produce favorable cognitive outcomes. However, studies concerning the association of second-line immunotherapy with cognitive outcomes have been scarce and have shown conflicting results regarding autoimmune encephalitis.

Hence, the goal of this study was to explore cognitive neural mechanism of autoimmune encephalitis by using neuropsychological tests and multi-mode MRIs.

The goal of this study was to explore cognitive neural mechanism of different types of autoimmune encephalitis by using neuropsychological tests and multi-mode MRIs. Neuropsychological tests involves the assessments of different cognitive domains. And multi-mode MRIs contains resting-fMRI, DTI and task-related fMRI.

Eligibility Criteria:
Inclusion Criteria: Diagnosis was established in all patients based on characteristic clinical presentation and detection of immunoglobulin G (IgG) antibodies.

-

Exclusion Criteria:

1. age \>60 years or \<16 years
2. notable lesions, such as tumors, scars, or vascular malformations, on brain MRI
3. a history of other neuropsychiatric disorders. -
HU007 in Patients with Dry Eye Syndrome

A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome


Eligibility Criteria:
Inclusion Criteria

* Age over 19
* Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 in at least one of both eyes
* Patients who have had more than one symptom of dry eye disease for at least 3 month before screening visit
* Best corrected visual acuity of 0.2 or higher in both eyes
* Those who voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion Criteria:

* Patients with clinically significant ocular disorders affected the test result
* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c \> 9%
* Wearing contact lenses within 72 hr prior to screening visit or during clinical trial
* Pregnancy or Breastfeeding
* Patient with a history of glaucoma, or intraocular pressure of 25mmHg or higher at least one eyes
* Patient with autoimmune disease (e.g. sjogren's syndrome)
* Patients with a history of corneal transplant or neurotrophic keratitis
Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia

This study will compare ultrasound 0.4 W/cm\^2 and 100% duty cycle versus no ultrasound (placebo) for bilateral masseter myalgia in up to 38 adult women. The dose will be applied for 5 minutes on each side. Both the dose and the starting side will be randomized. Both the subject and ultrasound operator will be blind to the dose. The outcome measures will be pressure pain threshold on both masseter muscles and both temporalis muscles, self reported pain scale (0, no pain to 10, worst pain ever), thermographic temperature of the muscles, and intraoral temperature. These outcome measures will be taken before and after each dose, so three times per subject.


Eligibility Criteria:
Inclusion Criteria:

Adult females Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) (Schiffman, et al., 2014) Current pain intensity ≥4 out of 10, (where 0 is no pain and 10 is the worst pain ever) on both sides.

Exclusion Criteria:

History or diagnosis of systemic musculoskeletal disorders. Rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). Certain conditions such as neoplasms or fractures. Neuropathies or neurological disorders. Currently taking muscle relaxants or analgesics. Any form of physical therapy within the last 60 days.
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* Has a BMI ≥18 and ≤40 kg/m2
* Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.

Additionally, meets the following criteria:

* Has residual excessive daytime sleepiness
* Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
* Is willing to adhere to additional protocol requirements

Exclusion Criteria:

* Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
* Is currently pregnant, breastfeeding, or planning to become pregnant during the study
* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening
Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI)

The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI) measured at the end of surgery for the prediction of immediate postoperative pain in postoperative care unit in adult patients undergoing general anesthesia.

Assessment of the performance of ANI to predict immediate postoperative pain on a 0-10 numerical rating scale (NRS) \>3 by building a receiver operating characteristic curve.

Eligibility Criteria:
Inclusion Criteria:

* adult
* ear-nose-throat or orthopedic surgical procedures
* halogenated and remifentanil-based general anesthesia

Exclusion Criteria:

* age \<18 yrs or \>75 yrs
* arrythmia
* administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
* psychiatric diseases
* autonomic nervous system disorders (epilepsy)
* inability to understand the verbal rating pain scale
Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak

Timely interventions may reduce the occurrence of post-traumatic stress disorder (PTSD) in ICU medical staff. Existing research suggests that either self-learning psychological relief methods or seeking online counseling or therapy from professional psychotherapists during the SARS-CoV-2 Omicron outbreak has the potential to alleviate the emotional distress and promote the physical and mental health of health care workers. Web-based online mental health interventions complemented by joint effective mental health advice can further reduce harmful negative effects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Non-ICU professional staff providing direct health care services to critically ill SARS-CoV-2 Omicron patients in the ICU
3. Signing the informed consent form

Exclusion Criteria:

1. No reported acute suicidal tendencies
2. No history of psychotic or dissociative symptoms
3. Pregnancy or lactation
4. Major family changes within the last 12 weeks( For e.g. death of immediate family member)
5. Participated in other clinical trials
REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)

Adult patients with early stage MF-CTCL (stage IA-IB) will be eligible for this study. A total of 100 early stage MF-CTCL patients diagnosed in the past year will be enrolled.

Treatment with CL gel will be applied once daily to all skin areas affected by MF-CTCL and, for 8 weeks, one selected skin area unaffected by MF-CTCL (0.5% body surface area) until treatment response (complete response), study treatment duration completed (56 weeks), progression, or another withdrawal criterion is met.

Depending on the type of skin drug-related reaction (if any) occurring after application of CL gel, this study will categorize patients into three different groups corresponding to three different treatment patterns:

* Group A: Patients with no skin drug reaction with CL gel application
* Group B: Patients developing a skin drug reaction of any grade with CL gel application, not due to allergic reaction to CL gel, will continue treatment at reduced application frequency
* Group C: Patients from Group B unable to tolerate reduced CL gel application frequency will apply a potent topical steroid twice daily in addition to CL gel applied every other day


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MF-CTCL stage IA or IB at enrolment as per ISCL/EORTC revision to the MF and Sézary syndrome classification and MF stage should have never met the criteria for stage IIA or higher in the patient medical history
* Lesions cover less than 80% of BSA
* Age ≥ 18
* ECOG/WHO performance status 0-2

Exclusion Criteria:

* Previous treatment with CL gel
* Concurrent or planned local or systemic anti-CTCL therapy
* Prior treatment with antihistamines or narrow band UV-B or PUVA therapy one week before enrolment, or systemic corticosteroids or radiotherapy in the last 4 weeks before enrolment
* Prior treatment with topical steroids in the patch test area (upper back) one week before enrolment
Relative Bioavailability and Food Effect Study

Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged 21 to 55 years
* Healthy is defined as no clinical relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
* Willing to use acceptable methods of contraception as outlined in the study protocol
* Body mass index between 18 to 30 kg/m2
* Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures

Exclusion Criteria:

* Subjects with evidence or history of clinically significant disease
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4
* Subjects with conditions possibly affecting drug absorption (eg gastrectomy)
* A positive approved immunoassay/ELISA blood test for TB
* Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men
* Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
* Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort
A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.

In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens:

Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Diagnosed asymptomatic HIV infection.
* HIV-1 RNA greater than 500 copies/ml.
* CD4+ T-cell count greater than 200/mm3.
* Never received antiretroviral therapy.

Exclusion Criteria

Co-existing Condition:

Excluded:

Severe non-HIV-related disease.

Patients with the following prior conditions are excluded:

History of neuropathy.

Prior Medication:

Excluded:

* Investigational drug within 1 month prior to study.
* Immunomodulatory drug within 1 month prior to study.

Prior Treatment:

Excluded:

* Radiation therapy within past month.
* Chemotherapy within past month.
Direct Anterior Approach for Femoral Neck Fractures

The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.

first included patient 23th November 2018

Eligibility Criteria:
Inclusion Criteria:

* Dislocated femoral neck fracture

Exclusion Criteria:

* Infection around the hip (soft tissue or bone)
* Pathologic fracture
* Excessive alcohol or substance abuse that most likely will give reduced compliance
* Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient.
* Bedridden patients/non-walkers
* Patients with an underlying illness that doesn't have life expectancy beyond six months
* In case of severe cognitive impairment where the patients are not able to give their informed consent
Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function

The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years or more with a weight of at least 50 kg and BMI between 18 and 40 kg/m2, inclusive.
* Negative screen for human immunodeficiency virus (HIV)
* For subjects with normal hepatic function, negative results for serum hepatitis B (HBV) surface antigen, HCV antibody, and HIV

Exclusion Criteria:

* Plasma or blood product donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
* Known or suspected history of drug/chemical abuse within the past 2 years as judged by the Investigator.
* Subjects with a history of surgery on the gastrointestinal tract.
* For patients with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).