cyrilzakka/clinical-trials huggingface dataset:
Individualized Pharmaceutical-care in Outpatients With Cancer Pain

The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients

This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients treated with sustained released morphine, oxycodone, and transdermal fentanyl.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older;
* Histologically confirmed solid tumor;
* Diagnosed chronic cancer pain;
* Opioid-tolerant patients;
* Overall survival is expected to be over 3 months;
* Karnofsky performance score≥50;
* Willing and able to comply with the protocol

Exclusion Criteria:

* Patients aged 18 years or older;
* Histologically confirmed solid tumor;
* Diagnosed chronic cancer pain;
* Opioid-tolerant patients;
* Overall survival is expected to be over 3 months;
* Karnofsky performance score≥50;
* Willing and able to comply with the protocol
Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue

This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on metabolic parameters and gene expression in subcutaneous adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 28
* Healthy subjects
* Normal glucose tolerance

Exclusion Criteria:

* Diabetes,IFG, IGT
* Chronical-inflammatory diseases
* Hb \< 12g/dl
* Elevation in liver enzymes or creatinin concentrations
* Great weight changes within last 12 months
* Any cancer diagnosis in last 10 years
Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

Eligibility Criteria:
Inclusion Criteria:

* Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
* Adults age 18 and older
* Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

* History of allergy to study drugs
* If a mensruating female, not pregnant and on adequate birth control.
* Children less than 18 years of age
* HIV + or at high risk for HIV infection.
Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder

1. To clarify the efficacy and safety of task-based repetitive transcranial magnetic stimulation (rTMS) on cognitive function in patients with stable bipolar disorder.
2. To analyze the therapeutic mechanism of transcranial magnetic stimulation based on magnetic resonance imaging and explore the abnormal regulation mechanism of cognitive neural circuits.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 14 to 45 years, right-handed;
2. Meet the diagnostic criteria for bipolar disorder in the stable remission period of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
3. Stable medication treatment;
4. Clinical remission for more than three months, Young Mania Rating Scale (YMRS) ≤ 6 points Hamilton Depression Rating Scale 17 (HDRS 17) score ≤ 7 points;
5. Cognitive impairment on the Cognitive Deficit Questionnaire (PDQ) ≥ 17 points;
6. Fully understand the transcranial magnetic stimulation treatment, be willing to actively cooperate with the treatment, and sign the informed consent.

Exclusion Criteria:

1. Those with a history of severe physical illness or diseases that may affect the central nervous system (such as tumors, syphilis, etc.);
2. Those with neurological diseases or risk of epileptic seizures, such as previous craniocerebral diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or a family history of epilepsy;
3. Those with contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as those with metal or electronic devices in the body (metal foreign bodies in the brain, cochlear implants, pacemakers and stents);
4. Those at high risk of suicide, or those who have already committed suicide or serious self-harm and need emergency intervention;
5. Those who are pregnant, breastfeeding, or planning to become pregnant during the trial;
6. Those with color blindness or hearing impairment;
7. Those with a history of substance or alcohol abuse;
8. Other situations that the researcher determines are not suitable as research subjects.
Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease

The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline solution) Nasal Spray as compared to placebo (vehicle) on signs and symptoms of dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit

Exclusion Criteria:

* Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g., laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within 12 months of the Screening Visit
* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, acute conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Have a known hypersensitivity to any of the procedural agents or investigational product components
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.
The Effect of Kinetic Brain Exercises on Balance and Dual Task Activities in the Elderly

The aim of the study is to evaluate the balance and dual-task activities of Kinetic Brain Exercises in healthy elderly individuals living in nursing homes.

A total of 33 people, 4 women and 29 men between the ages of 65-80 (73.88±3.69 years) completed in the research. Demographic and clinic information of the individuals were recorded and Dual Task Performance Tests for dual task activities, Timed Up and Go Test (TUGT) , Functional Reach Test for balance, 10 Meter Walk Test for walking speed, Fall Efficacy Scale (FES) for the fear of falling, Dual Task Questionnaire for to determine individuals difficulties during dual tasks and World Health Organization Quality of Life Instrument- Older Adults Module (WHOQOL-OLD) was used for quality of life. Individuals were applied an exercise program of 40 minutes, 2 days a week for 8 weeks. Individuals were divided into 2 groups. Kinetic Brain Exercises and Core Stabilization Exercises were applied to Group 1 (n=17), and only Core Stabilization Exercises were applied to Group 2 (n=16).

Eligibility Criteria:
Inclusion Criteria:

* Individuals living in nursing homes between the ages of 65-80,
* Having signed the Informed Volunteer Consent Form,
* Sufficient cognitive functions (Mini Mental State Test score being 24 and above)
* Those who can stand independently on their own

Exclusion Criteria:

* Those with neurological, musculoskeletal, inner ear or eye diseases that will cause impairment in vision or standing balance,
* Those with moderate and severe congenital heart disease, coronary heart disease and cerebrovascular disease
A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers.

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).

Eligibility Criteria:
Inclusion Criteria

Volunteers must have:

* Normal history and physical exam.
* HIV negativity.
* Absolute CD4 count \>= 400 cells/mm3.
* Normal urine dipstick with esterase and nitrite.
* Lower risk sexual behavior.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

* Positive hepatitis B surface antigen.
* Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
* Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
* Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.

Subjects with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
* History of anaphylaxis or other serious adverse reactions to vaccines.
* History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
* Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
* History of cancer unless there has been surgical excision that is considered to have achieved cure.

Prior Medication:

Excluded:

* Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
* Experimental agents within 30 days prior to study entry.
* Prior HIV vaccines.

Prior Treatment:

Excluded:

* Blood products or immunoglobulin within the past 6 months.

Identifiable high-risk behavior for HIV infection, including:

* History of injection drug use within past 12 months.
* Higher risk sexual behavior.
Prevalence of MIH in Young Adults At Cairo University Dental Hospital and Its Link to Dental Cavities: a Cross-Sectional Study

We are conducting a study to understand how often MIH (Molar Incisor Hypomineralization) occurs and whether it is linked to a higher chance of dental cavities (caries).

MIH is a condition where the enamel (the hard outer surface) of the first permanent molars and incisors (front teeth) doesn't develop properly, making these teeth more prone to damage and decay. We are looking at whether patients with MIH have more cavities in their teeth compared to patients without MIH.

This study aims to help us learn more about the connection between MIH and dental health, so we can improve care and prevention strategies for kids at risk of cavities.


Eligibility Criteria:
Inclusion Criteria:

* patients whose age between 18 and 30 years old provide informed consent Egyptian patients from both sexes

Exclusion Criteria:

* patients under or over this age group patients undergoing orthodontic treatment patients who refuse to participate
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children

Open-label, follow-up study for subjects who completed the EPITOPE study.


Eligibility Criteria:
Inclusion Criteria:

* completion of the EPITOPE study

Exclusion Criteria:

* Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
* Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma
NOVOCART®3D for Treatment of Articular Cartilage of the Knee

This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years old
* Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
* Minimum score on the KOOS questionnaire

Exclusion Criteria:

* Instability of the knee joint
* Arthritis
* Autoimmune disease
* Immune suppression
* Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
* Bone disease
* Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
ESS505 Pre-hysterectomy Protocol

This study has been designed to evaluate an investigational model of the Essure System for Permanent Birth Control. The investigational device is designed to offer all the advantages of the currently approved device. In addition, the investigational device offers immediate, permanent contraception without a three-month waiting period or 90-day confirmation test. This study has been designed to evaluate the effectiveness of the investigational device in causing tubal occlusion from insert placement through three months of wearing.

This study has previously been posted by Conceptus, Inc. (US).

After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy (LAVH), Total Abdominal Hysterectomy (TAH), Total Vaginal Hysterectomy (TVH), Total Laparoscopic Hysterectomy (TLH) with Bilateral Total Salpingectomy or Bilateral Salpingo-oophorectomy (BSO), or Laparoscopic Supracervical Hysterectomy (LSH)
* Subjects who are 18 years of age and older
* Subjects who are able and willing to provide written informed consent
* Subjects who agree to use a contraceptive method following Essure placement until the hysterectomy procedure

Exclusion Criteria:

* Subjects with bilateral proximal tubal occlusion
* Subjects who have undergone fallopian tube sterilization
* Subjects with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia
* Subjects who are post-menopausal
* Subjects with pelvic inflammatory disease (PID)
* Subjects with gynecologic malignancy
* Pregnancy or suspected pregnancy
* Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement
* Known allergy to contrast media
* Any general health condition that may represent, in the opinion of the Investigator, an increased potential risk associated with participation
Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. To investigate the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters of patients with metabolic neuropathies.

Metabolic disorder such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. The objectives of the present study are to investigate:

1. the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters
2. the best coaching modality of education.

This will be a prospective single blind study (blinded evaluator). Patients will be randomly assigned in two groups. The first group will have a one-day therapeutic education program followed by a 5-minutes phone call every week for 3 months. The second group will have the same one-day therapeutic education program that will be followed by an unique one-hour phone call. During the one-day therapeutic education program and the phone calls, hygienic rules (ie physical activities) and dietetic regimen advices will be given to patients. Evaluation will be done at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and neurophysiologic neuropathy (clinical signs of neuropathy and at least two low sensory nerve action potential (superficial peroneal and sural nerves))
* Metabolic disorder: Glucose disorder (diabetes mellitus or glucose intolerance) or metabolic syndrome
* Clinical signs for less than 2 years
* No therapeutic modification in the last 3 months
* Possibility to delay any drug modification during 3 months

Exclusion Criteria:

* Non metabolic neuropathy
* Serious diabetic complication
* Renal failure (creatinine clearance\<60ml/min)
* Sensory neuronopathy
* Contra-indication to physical activity
* Type 1 diabetes mellitus
* No written consent
Darbepoetin Alfa With or Without Intravenous (IV) Iron

To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Active non myeloid malignancy(cies) including lymphocytic leukemias
* Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy
* Anemia due to chemotherapy (screening Hgb \<or = 10.0 g/dL)
* at least 18 years of age at screening

Exclusion Criteria:

* Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS)
* Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy
* Active bleeding
* Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis)
* Active, unstable systemic or chronic infection
* Planned elective surgery during the study where significant blood loss is expected
* Unstable angina, or uncontrolled cardiac arrhythmia
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg)
* History of pure red cell aplasia (PRCA)
* History of deep venous thrombosis
* Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status
* Any red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening
* Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy
* Currently receiving or planned to receive myeloablative radiation therapy
* Received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study
* Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa)
* Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study
* Known sensitivity to iron administration
* Pregnant or breast feeding
Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)

Robotic-assisted total knee arthroplasty (TKA) was introduced to attempt to enhance the precision of bone preparation, component alignment and ultimately improve clinical results and survivorship of TKA. Although several published data suggest that bone preparation, and knee component alignment were improved by using robotic assistance, there is no high-quality evidence from randomized trials at long-term of which investigators are aware evaluating whether the improved bone preparation and knee component alignment improved clinical function or longevity of the TKA.

Robotic-assisted TKA was introduced in an attempt to enhance component alignment and to improve long-term clinical results and implant durability, particularly in younger patients. Several comparative studies of conventional and robotic-assisted TKAs demonstrated that improved alignment of the components was obtained after the robotic-assisted TKAs than conventional TKAs.

To date, however, no comprehensive synthesis of long-term randomized data has been conducted specifically for robotic-assisted TKA, particularly in younger patients. It is crucial to determine whether improved alignment of the TKA components obtained by using robotic-assistance, would improve better long-term and functional results and survivorship of TKAs.

The aims of the current study were to examine the two groups of patients after long-term follow-up to determine whether the clinical results, radiographic and CT scan results, and the survivorship of TKA would be better after robotic-assisted TKA than after conventional TKA.

Eligibility Criteria:
Inclusion Criteria:

* end stage knee arthritis

Exclusion Criteria:

* mild knee deformity
* inflammatory arthritis
* foot and ankle disorder
* dementia
* hip disease
* history of a stroke
* older than 65 years of age
n-3 Fatty Acids in Enteral Formula on NK Cell Activity

The aim of our study was to investigate the NK cell activity alternations and related cytokine changes in comparison with soybean oil used formula (control) and the canola and flaxseed oil used n-3 fatty acid enriched formula (n3EN, test) with non-surgical hospitalized patients for rehabilitation.

Patients were randomized to receive one of two types of enteral nutrition formula: soybean oil used enteral nutrition (control), vegetable (canola, flaxseed) derived n-3 fatty acid enriched enteral nutrition (n3EN). Blood samples were collected on the first day and 14 days after consumption of each formula and anthropometric parameters were collected. Hematology and biochemical values were analyzed and NK cell activities and serum cytokine productions were measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were admitted to the Severance Hospital Rehabilitation Department , enteral tube feeding patient, Adult male and female patients aged 19 years and over, Patients who signed the consent form

Exclusion Criteria:

* Patient with nausea
* Patients with hepatic impairment (total bilirubin concentration\> 3.5 mg / dl)
* Patients with renal impairment (serum creatinine concentration\> 3 mg / dl or requiring peritoneal or hemodialysis) diabetic patients
* Patients who are undergoing chemotherapy or who are within 1 month of the end of chemotherapy
* Patients whose life expectancy is less than 1 month
* Pregnant women and women who are pregnant