cyrilzakka/clinical-trials huggingface dataset:
Remote Monitoring and Support for Patients With Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence

Moma call center will provide unique service -Remote monitoring and support for mental health patients .The aim of this reserch is reducing hospitalization and improve adherence, by reaching out and there for monitoring very closely .

"Moma" call center is a result of collaboration between Maccabi Health Services and The Gertner Institute of Epidemiology and Health Policy Research. The call center provides remote continuous monitoring and support for patients with chronic illnesses, and has been found useful for improvement in treatment adherence and other clinical measures in patients with diabetes and CHF.

The current project focuses on patients diagnosed with schizophrenia, schizoaffective disorder and bipolar disorder. Patients that suffer from these disorders are prone to low adherence and are at risk for discontinuation of treatment and frequent relapses.

The advantages of the "Moma" call-center include high availability, reaching out, collaboration between treatment centers and agents, and continuous remote monitoring. We hypothesize that these factors will enable improvement of support provided to these patients, early detection of their needs, connection with community care agents, monitoring of treatment adherence, and remote interventions targeted towards prevention of relapse.

Eligibility Criteria:
Inclusion Criteria:

Men \& women,

1. age 18-60 ,
2. "Maccabi Health service" patients with diagnosis of: schizophrenia, Schizo - effective or Bipolar Dis.
3. Must have 30 days or more of hospitalization (during 3 years). Treated with psychiatric medication.
4. Living independently or with a help of a caregiver.
5. Is able to provide written informed consent.

Exclusion Criteria:

1. Violent, or suicidal.
2. Drug\\ Alcohol, addiction,
3. End stage Disease (Cancer, ESRF act.)
4. Non - in depended and without Care giver/legal guardian
Osteoarthritis Running & Cartilage Assessment

Knee osteoarthritis (OA) is a debilitating disease affecting millions of Canadians. Exercise is a core treatment for knee OA, and is advocated by all clinical guidelines. However, the safety of recreational running in the presence of knee OA is unclear. There are no studies available to provide direct data to appropriately inform runners and clinicians whether running should be advocated for joint health. Our research study will address this gap.


Eligibility Criteria:
Inclusion Criteria:

ALL:

* aged greater than 40 years
* recreational runners who run at least twice per week for a total of at least 10 km, and have done so for a minimum of 12 months
* comfortable running on a treadmill for 30 minutes.

TFOA Group:

* exhibit radiographic evidence of mild or moderate tibiofemoral osteoarthritis (TFOA) according to the Kellgren and Lawrence OA classification scale (grade ≥ 2)
* report knee pain on most days of the previous 3 months (during running and activities of daily living).

Control Group:

* free of any radiographic signs of TFOA according to the Kellgren and Lawrence scale (grade = 0)
* pain free in both knees for the 12 months prior to recruitment.

Exclusion Criteria:

ALL:

* any history of traumatic knee injury (fracture, severe sprain, meniscus injury)
* presence of an inflammatory arthritic condition
* presence of any health condition (other than OA in the TFOA group) affecting normal movement or precludes engaging in moderate to high impact activities such as running
* use of any oral or injected corticosteroids or viscosupplementation in the previous 6 months
* any history of surgery in either knee
* standard contra-indications to magnetic resonance imaging (MRI).
Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS

Despite its significant impact on individuals and healthcare systems, substantial gaps remain in the clinical and rehabilitative management of depression in oncology patients.

Depression in cancer patients is often under-recognized and untreated, and screening tools and structured healthcare pathways are lacking. Even when depression is identified in oncology patients, evidence of effective treatments is limited. There are no specific guidelines for psychotropic drug use in cancer patients, and antidepressant efficacy is uncertain despite their frequent use.

Emerging strategies like transcranial magnetic stimulation and cognitive rehabilitation show promising findings. However, the cost-effectiveness of therapeutic strategies is understudied.

Repetitive transcranial magnetic stimulation (rTMS) is already used for the treatment and relapse prevention of depression both as monotherapy and as an add-on to antidepressant pharmacotherapy, and it appears effective in improving cognitive performance. However, it has not yet been applied to treat depressive disorders in oncology patients.

Virtual reality-based cognitive behavioral intervention (VR-COG) is designed to improve cognitive functioning, a central feature of depression in oncological conditions. VR-COG enhances learning and skill acquisition with better ecological efficiency than traditional cognitive remediation programs. VR approaches are well-received by oncology patients and show promise in reducing anxiety and depressive symptoms.

The trial aims to evaluate the effectiveness of highly specialized, nonpharmacological interventions on depressive symptoms and quality of life in oncology patients. Specifically, repetitive Transcranial Magnetic Stimulation (rTMS) and Virtual Reality-based Cognitive Remediation (VR-COG) will be analyzed, alongside standard Treatment as Usual (TAU), in comparison to TAU alone. This trial also aims at evaluate cognitive functioning, depression-related conditions and the cost-effectiveness of the interventions under study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of oncological disease in the last 5 years
* Diagnosis of Major Depressive Disorder, without psychotic symptoms, according to DSM-5 criteria
* 17-item Hamilton Rating Scale for Depression (HAM-D-17) (score ≥14)
* Age: 18 years or older
* Oncological disease in a non-advanced stage (Karnofsky Performance Status \> 80)

Exclusion Criteria:

* Current or prior hospitalization in the next 6 months
* Planned surgery in the next 6 months
* Suicidal ideation
* Substance use
* History of significant head trauma, neurological disorders, intellectual deficits
* Recurrent seizures resulting from head trauma or conditions lowering seizure threshold
* Concurrent use of medications that increase the risk of epileptic seizures (e.g., antipsychotics, tricyclics, theophylline)
* Glaucoma, retinal detachment, or other serious vision impairments that may prevent the use of virtual reality technology
* Severe problems with autonomous ambulation
VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)

Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator

Prospective, observational, un-blinded, multi-site study designed to collect data on patients implanted with a Model 106 VNS Therapy System from baseline through an EMU stay of up to 5 days, and 6-month follow-up. After the 6-month follow-up, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of medically refractory epilepsy with partial onset seizures suitable for implantation with the VNS Therapy System.
* Patients willing to undergo an EMU evaluation for a period of at least three days with activation of the AMM feature during that time.
* Patients must be at least 12 years old.
* Patients must be in good general health and ambulatory.
* Patient or guardian must be willing and able to complete informed consent/assent.

Exclusion Criteria:

* Patients have had a bilateral or left cervical vagotomy.
* Patients currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
* A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
* Patients expected to require full body magnetic resonance imaging (MRI).
* Patients have a history of implantation of the VNS Therapy.
* Patients with an IQ known or estimated to be \< 70, history of depression requiring hospitalization, or suicidality as defined by DSM IV-TR that in the investigator's judgment would pose an unacceptable risk for the patient or prevent the patient's successful completion of the study.
* Patients with a history of status epilepticus within 1 year of study enrollment.
* Patients with known clinically meaningful cardiovascular arrhythmias as well as patients with clinically meaningful cardiovascular arrhythmias determined by a 24-hour Holter recording obtained during the baseline period.
* Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years.
* Patients with a history of psychogenic non-epileptic seizures.
* Women who are pregnant. Women of childbearing age must take a pregnancy test and agree to use an approved method of contraception during the study.
* Patients currently enrolled in another investigational study.
A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration

This is a multicenter, randomized, double-blind, active-controlled, parallel group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients with Neovascular(wet) Age related Macular Degeneration

Subjects will be randomised in a 1:1 ratio to receive either CKD-701 or Lucentis®. Investigational Products (IP) (CKD-701 or Lucentis®) will be administered once a month during the loading phase(the first three months), and for the next nine months(PRN phase), administion will be determined based on the PRN administration criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥50 years
2. Presence in the study eye of active subfoveal CNV lesion due to AMD
3. The total lesion size ≤ 12 DA in the study eye
4. The presence of CNV foci of more than 50% of the total lesion area in the study eye
5. The best-corrected visual acuity within a range from 78 to 34 letters (20/32\~20/200) measured using the ETDRS chart in the study eye
6. Written informed consent

Exclusion Criteria:

1. Any previous anti-vascular endothelial growth factor(anti-VEGF) treatment to treat neovascular AMD
2. Presence of eye-related inflammation or infection, such as Infectious ophthalmitis, corneal inflammation, conjunctivitis (including scleromalacia), endocular inflammation
3. Any history or clinical basis of disease affecting the retina except age-related macular degeneration(AMD), such as diabetic retinopathy, diabetic macular edema
4. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, angioid streaks retinopathy or pathologic myopia
5. Patients with macular abnormalities other than age-related macular degeneration (AMD)
CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

The purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (Rutherford IIA to III)
* Informed consent of the patient

Exclusion Criteria:

* Previous attempt of recanalisation (e.g. lysis therapy)
* Known A. poplitea aneurysm of the affected extremity
* Severe heart failure NYHA IV
* Known atrial thrombus
* Terminal renal insufficiency (creatinine \>10mg/dl or current dialysis therapy, previous transplantation of kidney)
* Hypersensitivity to allopurinol
* Hypersensitivity to one component part of the reperfusion solution
* Participation in a clinical trial during the study or 30 days before
* Pregnancy or lactation
* Patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial
* Abuse to drugs or alcohol
Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer

The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and gastroesophageal junction cancer.

This is a single arm trial. All Patients will receive up to 6 cycles of triple chemotherapy with docetaxel, cisplatin and S-1. Given the severe toxicity of DCF regimen, here the total dose of docetaxel and cisplatin is both reduced to 60mg/m2. For patients with CR/PR/SD disease after 6 cycles of chemotherapy, maintenance therapy with S-1 are recommended. Antitumor activity will be evaluated every two cycles according to RECIST1.1.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed unresectable advanced gastric or gastroesophageal junction cancer;
* No previous chemotherapy and radiation for advanced disease except palliative radiation for a local pain control;
* At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
* ECOG (Eastern Cooperative Oncology Group) performance status 0-1;
* Recovery from the toxicities of previous therapy;
* Adequate bone marrow and organ function. Hb≥8 G/L; Absolute neutrophil ≥ 2.0 G/L; PLT ≥100 G/L ;ALT/AST ≤1.5 ULN or ≤5ULN with liver metastases; TBIL ≤1.5 ULN; Cr≤1.0 ULN;
* Life expectancy ≥3 months;
* For men and women of childbearing potential, agree on taking effective contraceptive method of birth control from the signed informed consent until 3 months after the last study drug administration;
* Signed informed consent.

Exclusion Criteria:

* Pathology type other than adenocarcinoma,such as squamous cell carcinoma;
* Previous treatment with taxanes, cisplatin or S-1;
* Relapse within 6 months after the end of adjuvant chemotherapy;
* Known brain metastases;
* Complete or incomplete intestinal obstruction or uncontrolled gastrointestinal bleeding;
* Known deficiency of DPD enzyme;
* Kown HIV infecton or drug addiction;
* Any acute or chronic medical or psychiatric condition that would make the patient inappropriate for entry into this trial in the judgement of investigators;
* Myocardial infarction within 6 months prior to the entry of this trial;
* Known history of allergic reaction to taxanes and platinum;
* Pregnant or breast feeding women.
Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C

This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up. Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months. Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period. At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.

This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up. Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months. Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period. At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C patients treated with interferon plus ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct antiviral drugs (DAAs)

Exclusion Criteria:

* Co-infected with hepatitis B virus or human immunodeficiency virus
* Had an autoimmune disease, liver tumour, or severe cardiac disease.
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.


Eligibility Criteria:
Key Inclusion Criteria:

- Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)

Key Exclusion Criteria:

* History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.
* Prior natalizumab therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.

Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current antiretroviral regimens, and is administered in one of three dosing regimens. Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have an HIV count of 400 - 50,000 copies/ml.
* Are expected to live for at least 1 year.
* Have been taking the same anti-HIV drug combination (made up of no more than 3 anti-HIV drugs) for at least 8 weeks prior to study entry.
* Are at least 18 years old.
* Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have taken medications for certain infections within 15 days prior to study entry.
* Have a history of cancer, except Kaposi's sarcoma (KS) or skin cancer.
* Develop a new AIDS-related condition within 30 days of study entry.
* Have certain serious medical conditions, including severe nausea, vomiting, or other stomach problems that make you unable to take medications by mouth.
* Have received a vaccine within 30 days prior to study entry.
* Have taken certain medications, including those that may affect your kidneys.
* Abuse alcohol or drugs.
* Are pregnant.
Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)

The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.


Eligibility Criteria:
Inclusion Criteria:

* Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.

Exclusion Criteria:

* Concurrent topical or systemic medications that may impair healing including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
* Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
* Anterior basement membrane dystrophy.
* History of recurrent epithelial erosion.
* Significant dry eye (symptomatic sith Schirmer \<5mm at 5 minutes)
* Other corneal epithelial disorder or healing abnormality