cyrilzakka/clinical-trials huggingface dataset:
ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia (Phase 2)

The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the second phase. The phase 2 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its clinical effectiveness, safety, usability, and acceptability among patients with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years old or older
* Diagnosed with mild to moderate Alzheimer's dementia according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Montreal Cognitive Assessment-Philippines (MOCA-P) score of 10-20 inclusive
* Neuropsychiatric Inventory (NPI-12) score 1-50 inclusive
* Reisberg Scale Stage 4-5 inclusive
* Stable dose of antidepressants for the past 6 weeks
* Stable dose of antipsychotics for the past 4 weeks
* Able to walk unassisted or with minimal assistance, with or without assistive device
* No other explanation for condition based on reasonable clinical diagnostics

Exclusion Criteria:

* Have mild cognitive impairment (no dementia)
* Have MOCA-P score less than 10 or more than 20
* Other non-amnestic dementia syndromes
* Have receptive aphasia
* Have significant visual or hearing impairment
* Have an active psychiatric disorder prior to Alzheimer dementia diagnosis
* Had previous episodes of seizures, diagnosis of epilepsy, or intake of antiepileptic or seizure medications
* Have quadriplegia or paralysis of the dominant hand
* Have a history of motion sickness
* Experience claustrophobia
* Have a diagnosis of a terminal illness or a life expectancy of less than one year
Audio Recording for Improved Surgical Outcome (ARISO)

Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients.

Pt undergoing orthopedic surgery are randomized into 3 groups. These interventionals will be listening to CD recording just prior to and during orthopedic surgery. The 2nd group will be listening to a recording before and during surgery without any positive suggestions. The 3rd group will be receiving usual care. Prior to hospital discharge patients will fill out a questionaire assessing their perception of their surgery and hospital stay. Pt. charts will be reviewed for use of pain, sleep, anesthesia and nausea medication and for the number of units of blood transfused. Pt. outcomes will be asssessed with this data.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total hip replacement under reginal anethesia at Mayo Clinic in Jacksonville, Fl.
* Willingness to sign consent.
* Age 18 or greater.
PTH - Preemptive Treatment for Herpesviridae

The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of ventilator-free days at Day 60.


Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilation \> 96 hrs and expected duration of mechanical ventilation of at least 2 days
* positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR
* age \> 18 years
* informed consent
* negative pregnancy test

Exclusion Criteria:

* \< 18 years
* Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV
* Had received antiviral agent active against HSV/CMV during the previous month
* Hypersensitivity to aciclovir/ganciclovir
* Pregnancy
* Breast feeding
* Bone marrow failure
* Solid organ recipients
* Bone marrow recipients
* HIV positive patients
* Receiving immunosuppressive agents
* SAPS II \> 75
* Withdrawing/withholding
* Neutropenia (\< 500 mm3)
* Thrombocytopenia (\< 25 G/L)
* ICU readmission
Arterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump

The aim of this study is to evaluate the different performance of arterial and venous graft with intra-aortic balloon pump support following coronary artery bypass.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing coronary artery bypass surgery

Exclusion Criteria:

* Aortic insufficiency;
* Diffuse atherosclerosis impeding intra-aortic balloon pump introduction
Sexual Effects of Transdermal or Vaginal Testosterone

The aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety.

-General To evaluate the therapeutic efficacy of testosterone treatment in sexual dysfunction in postmenopausal patients.

-Specifics

1. To evaluate the prevalence of different sexual dysfunctions in postmenopausal patients, classifying them according to Diagnostic and Statistical Manual of Mental Disorders 5th (2013):

   * Female sexual desire / arousal disorder;
   * Female orgasm disorder;
   * pelvic or genital pain / penetration disorder;
2. To evaluate the response on climacteric symptoms after testosterone replacement using the Kupperman Menopausal Index;

Eligibility Criteria:
Inclusion Criteria:

* Brazilian women with menopause time from 2 to 6 years;
* active sex life;
* absence of severe depression and anxiety, as evidenced by the Beck (depression specific) and Beck (anxiety specific) questionnaires;

Exclusion Criteria:

* disabling diseases;
* use of medicines that inhibit sexual desire;
* inability to answer the questionnaires;
* altered routine exams and comorbidities:

  * Severe hypertension with Blood Pressure measurement \> 160 mmHg (maximum) or/and 90 mmHg (minimum) in two measurements
  * clinical or subclinical thyroid dysfunction: thyroid-stimulating hormone over 4
  * triglyceride dyslipidemia\> 400
  * presence of occult blood in stool
  * hyperprolactinemia
  * fasting blood glucose\> 100
  * presence of osteopenia or osteoporosis
  * BIRADS score greater than or equal to 3 on mammography
  * presence of endometrial echo\> 4mm on transvaginal ultrasound
  * Presence of changes in oncotic colpocytology
* Diagnosis after psychological screening for moderate to severe anxiety / depression.
Outcome After Coronary Artery Bypass Grafting

The E-CABG registry is a multicenter, European registry collecting data on the preoperative characteristics, treatment strategies and outcome of patients undergoing isolated coronary artery bypass grafting (CABG).

Improvements in the surgical treatment of coronary artery disease are possible only when implementation of current methods and development of new methods are based on the solid ground of large and reliable clinical data. Furthermore, clinical findings assume even more significance when detected in study populations from different institutions with heterogeneous referral pathways, baseline clinical characteristics and perioperative treatment strategies. The rationale of this European multicenter study is therefore to prospectively collect data on baseline characteristics, operative and anesthesiological methods and postoperative outcome of patients undergoing CABG in eleven cardiac surgery centers from five European countries. This multicenter prospective registrywill provide data to evaluate the prognostic impact of a number of patients' risk factors as well as the efficacy and safety of operative methods and drugs used during the pre-, peri- and postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Patients of aged \> 18 years undergoing isolated CABG for stable coronary artery disease or acute coronary syndrome. Patients undergoing Maze procedure will be included in this registry.

Exclusion Criteria:

* Patients undergoing any other major cardiac surgery procedure will be excluded from this registry.
Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.

The study is a double-blind randomized controlled clinical trial of approximately 118 patients (males and females) who are at least 40 years of age, who are scheduled for Total Knee Arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive Kneehab XP and a standard rehabilitation program and 2) a control group who receive only a sham device and a standard rehabilitation program. Patients are tracked for measures of function, pain, quality of life, physical performance and acceptable states status at 6 weeks and 1 week before surgery and 3, 6, 12, and 52 weeks following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are scheduled for Total Knee Replacement surgery with the Smith and Nephew Visionaire prosthesis and the anterior surgical approach.
* Individuals who are at least 40 years of age.
* Individuals with a body mass index (BMI) \<40 kg/ m2
* Individuals who are walking independently with or without assistive devices.
* Individuals with a Short Performance Battery Score greater than 7.
* Must be able and willing to complete all study assessments and to be followed for the full course of the study.
* Must be able to read, write and follow instructions in English.
* Must be able and willing to provide informed consent.
* Must be willing and able to attend the additional pre-operative assessment.

Exclusion Criteria:

* Individuals with a history of foot and/or ankle pathology.
* Individuals with a history of tibial or femoral fractures.
* Individuals with a history of any underlying neurological conditions.
* Individuals with physical conditions which would make them unable to perform study procedures.
* Individuals with a total hip replacement.
* Individuals undergoing revision TKA of the same operated leg.
* Individuals who are pregnant.
* Individuals diagnosed with a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site.
* Individuals with an active implanted medical device (i.e. pacemaker, pump)
* Individuals with a history of stroke
* Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)
* Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis).
* Individuals with muscle diseases (i.e. muscular dystrophy)
* Individuals with visible skin injury or disease on their legs.
* Individuals who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
Acute Exposure of Simulated Hypoxia on Pulmonary Artery Pressure and Right Heart Function (Echo)

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on pulmonary artery pressure and right heart function (Echo).

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, (six-minute walk test) 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.

Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a (pulmonary artery wedge pressure) PAWP ≤15 mmHg during right heart catheterization at the time of initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting partial Oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
* Women who are pregnant or breast feeding
Brain Functional Connectivity Changes Following Cognitive Rehabilitation in Multiple Sclerosis: an fMRI Study

This trial seeks to investigate brain network changes following cognitive rehabilitation in MS patients. The investigators hypothesize that rehabilitation interventions improve connectivity in the brain.Novel Magnetic Resonance Imaging technique is performed to investigate changes in brain plasticity.


Eligibility Criteria:
Inclusion Criteria:

* Definitive MS diagnosis
* Right handedness
* EDSS 0-4
* No relapse in past 6 weeks
* Willing to consent and participate in the study

Exclusion Criteria:

* Pregnancy
* Left handedness
* Neurologic or psychiatric disorder other than MS
Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy

Study Procedures:

All patients will undergo the following:

Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.

1. History taking:

   * Personal history: name, age, occupation and address.
   * Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration.
   * Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin.
2. Medical examination:

   * General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill)
   * Abdominal examination to assess fundal height.
3. Investigations to perform will include:

Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.

Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.

Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.

This study included two groups:

Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.

Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.

hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks

Eligibility Criteria:
* The study will include women with the following inclusion and exclusion criteria:

Inclusion criteria:

1. Pregnant women with single fetus
2. Microcytic hypochromic anemia, mild anemia Hb 10 to 10.5 g/dl) and moderate anemia (Hb 7 to 9.9 g/dl)
3. Gestational age (14 - 35 weeks)
4. Serum ferritin level \&amp;lt;24 ng/dl

Exclusion Criteria:

1. Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
2. Associated bleeding disorder
3. Anaemia requiring blood tranfusion (Hb \&amp;lt; 7gm/dL)
4. Hypersensitivity to iron preparations
5. Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)
Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold standard therapy for SNV is currently represented by the association of Cyclophosphamide and Prednisone. The limits of this approach are the high frequency of recurrent disease and an increased incidence of malignancy and infections. The aim of the present study is to compare the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinically active SNV
* Life-expectancy \> 1 year
* Written informed consent

Exclusion Criteria:

* Creatinine clearance \< 10 ml/min/1.73 mq
* Aminotransferase levels more than twice the upper limit of the normal range
* HBsAg positivity
* anti-HCV Ig and HCV-RNA positivity
* HIV positivity
* Active malignancies
* Coexistence of connective tissue disease
* Prednisolone, cyclophosphamide or methotrexate hypersensitivity
* Pregnancy
Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors

This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Patients must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
4. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
5. ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.
6. Adequate organ function.

Exclusion Criteria:

1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
3. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
4. History of ILD or noninfectious pneumonitis requiring steroids or other immune suppressive agents ≤ 2 years before the first dose of the study drug, or with current ILD/noninfectious pneumonitis, or where suspected ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
6. Active hepatitis C.
7. Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.


Eligibility Criteria:
Inclusion Criteria:

* Long duration treatment with corticosteroids (started or ongoing)

Exclusion Criteria:

* History of osteogenesis imperfecta, multiple myeloma or Paget's disease
* History of Hyperparathyroidism, hyperthyroidism
* History of Osteomalacia

Other protocol-defined inclusion/exclusion criteria may apply.
The Effectiveness of Lower Cyclosporine Doses for Psoriasis

This study will evaluate whether lower doses of cyclosporine can cause fewer side effects and still produce the same beneficial results that are seen with a standard cyclosporine dose regimen when treating individuals with moderate to severe psoriasis.

Psoriasis is a chronic inflammatory skin disease. It is believed to be caused by an overactive immune system that speeds the growth of skin cells. This abnormal skin growth results in patches of inflamed skin, which can itch, crack, and bleed. Cyclosporine is an immunosuppressant drug that is used in more severe cases of psoriasis to slow down the growth of skin cells. However, cyclosporine use is associated with several side effects, including kidney damage, high blood pressure, and skin sensitivity. This study will evaluate whether lower doses of cyclosporine can cause fewer side effects and still produce the same beneficial results that are seen with the standard administration of cyclosporine.

Participants in this study will receive treatment with cyclosporine for up to 30 weeks. Study visits will occur every 2 weeks and will include a physical exam, a psoriasis symptom evaluation, blood collection, and various questionnaires on quality-of-life issues. Participants will be followed for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Good health
* Exception that has been resistant to psoralen and ultraviolet A radiation (PUVA), methotrexate, and retinoids
* Moderate to severe, stable plaque psoriasis
* Normal organ and marrow function
* HIV uninfected

Exclusion Criteria:

* Topical therapy within 4 weeks of study entry
* Use of systemic, intralesional, or phototherapy within 1 year of study entry
* Use of cyclosporine in the past or use of other immunosuppressive medication within 6 months of study entry
* Inability to be followed or monitored regularly on a weekly basis
* Poorly controlled hypertension
* Severe infection, internal malignancy, immunodeficiency, gout, or liver disease
* Received more than 1,000 treatments of ultraviolet A (UVA)
* History of allergic reaction attributed to compounds of similar chemical or biological composition to cyclosporine
* Uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit study participation
* Women of childbearing potential and men unwilling to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of the study
* Pregnant