cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 18 yrs and \<70 yrs with histologically or cytologically confirmed
* Malignant disease
* Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60
* Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 \~ 80 mg/m2 on study Day 1
* Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
* Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion
* Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion
* Predicted life expectancy of ≥ 3 months
* Provision of written informed consent.

Exclusion Criteria:

* Inability to understand or cooperate with study procedures
* Receipt of investigational drugs ≤ 30 days before study entry
* Receipt of other investigational drugs during the course of this study
* Seizure disorder or any condition requiring anticonvulsants, sedatives
* CNS malignancy or metastasis
* Ongoing emesis due to obstruction of digestive tract
* Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy
* Moderate or severe nausea and vomiting after any previous chemotherapy
* Scheduled receipt of any chemotherapeutic agent with an emetogenicity level \>3 during study Days 2-5
* Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5
* Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5
* Contraindications to 5-HT3 receptor antagonists
* Contraindications to chemotherapy
A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

A Study to Assess the effect of CT-868 in hemoglobin A1c (HbA1c) in Overweight and Obese Participants with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Males or Females with T2DM
* BMI of ≥27 kg/m2, inclusive
* 18-75 years old, inclusive
* Stable body weight for 3 months

Exclusion Criteria:

* Significant medical history
* Uncontrolled diabetes
* History of malignancy
Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway in Patients After Knee Arthroplasty

The aim of this study is to determine the clinical efficacy of gait rehabilitation robot through cortico-spinal-muscular pathway activation of the muscles remotely located from the end-effecter in patients after total knee arthroplasty.

pre-interventional evaluation; within 1 day of intervention start primary end point; 3 days after intervention start secondary end point; 5 days after intervention start

Eligibility Criteria:
Inclusion Criteria:

* Patients after Unilateral Total Knee Arthroplasty

Exclusion Criteria:

* brain disease, spinal cord injury, peripheral neuropathy, myopathy
* Inability to ambulate fully due to muscukoskeletal disorders
* MMSE\<23
* history of arthroplasty surgery on either of legs
* Cardiac pacemaker
* Refusal of participation
Anesthesic Propofol and Remifentanil Requirements in Obese Patients

Pharmacokinetic models for anesthetic agents are questionable. The objective of the study is to compare the propofol and remifentanil doses required to maintain the bispectral index in the range 40-60 in two groups of patients: obese patients and lean patients


Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled for a bariatric coelioscopic surgical procedure (obese patients) or for an upper abdominal laparoscopic procedure (lean patients)

Exclusion Criteria:

* age lower than 18 years,
* pregnant woman,
* presence of a central neurological disorder or a lesion cerebral, of a severe respiratory or hepatic insufficiency,
* allergy to propofol, or to soja or to peanuts, or to sufentanil, or to remifentanil, or to morphine, or to a muscle myorelaxant, or to an excipient,
* hypersensibility to sufentanil, or to remifentanil or to another derivate of fentanyl,
* allergy to latex,
* presence of a symptomatic gastroesophageal reflux,
* patients receiving a psychotropic treatment or a agonist-antagonist opiate,
* presence of predictive signs of difficult mask ventilation of difficult intubation (else than obesity)
Retrospective Study on the Use of Immunotherapy in Patients With MSI-H Metastatic Colorectal Cancer

An increasing number of patients with metastatic colorectal cancer (mCRC) are able to receive 3 or more lines of therapy. In this setting, can be recognize treatments such as regorafenib (an oral multikinase inhibitor), trifluridine/tipiracil hydrochloride (TAS-102), an antineoplastic nucleoside analogue, and antibodies anti-epidermal growth factor receptor (EGFR) in patients with RAS wild-type tumors (if no prior exposure to antibodies). Maintaining quality of life is an essential goal for third- and later-line treatments for patients.

The anti-programmed cell death protein 1 (anti-PD-1) immune checkpoint inhibitors, pembrolizumab and nivolumab, were approved in the US by the FDA in 2017, and the combination nivolumab plus ipilimumab (anti CTLA-4) was recently approved by the FDA in 2018, all in the second and later-line setting for patients with microsatellite instability-high (MSI-H) or deficient DNA mismatch repair mCRC whose disease has progressed despite treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. At present, these agents are not approved in Europe for mCRC patients with MSI-H. Clinical trial results and scientific data supported evidence that immunotherapies provide benefit but are limited to the small proportion (\< 5%) of patients with MSI-H tumors, in whom they are highly effective. Therefore, patients with MSI-H disease should be referred as expeditiously as possible to receive immune checkpoint inhibitors.

The aim the study is to retrospectively collect data of patients treated with immunotherapy in the context of real clinical practice, in order to describe the real impact in terms of clinical outcomes and tolerability of treatment in common clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for alive patients
* Patients with diagnosis of colorectal cancer with MSI-H
* Patient treated with at least one administration of antibody anti PD-1 for colorectal cancer prior to 30 June 2020 outside clinical trials.
* Availability of the tumor tissue from the primary tumor or a metastatic site for molecular analyses. The availability of tumor tissue is recommended but not mandatory.

Exclusion Criteria:

* Patients who received immunotherapy during a clinical trial.
A Safety and Efficacy Study to Evaluate Rosacea

To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.

This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 65 year with rosacea, 10 to 30 papules and pustules (at least 5 lesions within the treatment area on each facial side), and \< 2 nodules
* Presence of moderate to severe persistent erythema
* Total body weight \>45 kg

Exclusion Criteria:

* Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
* Extremely dark skin type that would confound the digital analysis of erythema (eg, Fitzpatrick Skin Type 5 or 6)
* Excessive facial hair (eg, beards, sideburns, moustaches, etc.), birthmarks, or tattoos that would interfere with diagnosis or assessment of rosacea
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to start of treatment.
* Hypersensitivity or allergy to axitinib or any other component of the study treatment
* Use within 6 months prior to baseline and during the study of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
* Use within 6 weeks prior to baseline and during the study of vasodilators or α-adrenergic receptor-blocking agents.
* Use within 1 month prior to baseline and during the study of 1) topical retinoids to the face, 2) systemic antibiotics know to have an impact on the severity of facial rosacea (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim), 3) systemic corticosteroids, or 4) facial light-based therapies
ADHERE-S (NIS Brilique)

noninterventional study investigating persistence and adherence on ticagrelor in ACS patients in Serbia


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* diagnosed with ACS - STEMI or NSTEMI or unstable angina, invasively or non-invasively treated
* Patients already on treatment with ticagrelor at least for 1 month and no longer than 3 months prior to study initiation. Enrolment in this study must not be trigger for ticagrelor initiation.
* read and signed the Informed Consent Form

Exclusion Criteria:

Any contraindications as per approved SmPC of Brilique

• Patients with life-threatening conditions which could disable patients to comply with scheduled visits and/or not able to fill in the patient questionnaires.
Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis

The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs). it is designed to test the hypothesis that there is a difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using autografts and those in which such procedure was performed with the Tavor prosthesis.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is \>= 18 years old
2. Patient has a ruptured ACL
3. Operated knee has full range of motion and no swelling
4. Patient understands the study requirements and the treatment procedures and rehabilitation and provides written Informed Consent before any study-specific tests or procedures are performed.
5. The patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic.

Exclusion Criteria:

1. Skeletal immaturity
2. Pregnancy
3. Patient with:

   * Uncontrolled systemic hypertension
   * Severe uncontrolled Diabetes Mellitus
   * Epiphyses That Have Not Yet Closed
   * Periarticular or Patella Fracture
   * History of Metabolic Bone Disease (e.g.., Osteoporosis, Rickets)
   * Crystal deposition disease, e.g., gout
   * Inflammatory joint disease, e.g., rheumatoid arthritis
   * Severe degenerative joint disease
   * Known neoplastic disease
   * HIV positive
   * Current steroid therapy in excess of prednisone 5 mg/day
   * Other severe, life-threatening systemic disease or any medical condition that interferes with their ability to participate in a rehabilitation program
4. The subject has participated in, or is planned to participate in, any investigational drug or device study within the past 30 days and for the duration of this study.
The Influence of Motor Imagery in Fine Motor Skills

The main purpose of this study is to ascertain whether the application of Motor Imagery together with normal practice improves fine motor skills in disabled individuals.

Imagery is a cognitive process that can play an important role on the planning and execution of different movements or actions. The main purpose of this study is to ascertain whether the application of Motor Imagery together with normal practice improves fine motor skills in disabled individuals. In this study participated 42 subjects of both genders with disabilities, with a mean age of 37 (SD=12). Subjects were randomly divided in two groups: a control group and an experimental one. The study procedures were applied on five different tasks of the Psychomotor Battery of fine motor skills (BPM). This instrument was applied in two stages, at the beginning of the study (pretest) and at the end of the 4 weeks (posttest). Both groups performed the tasks twice a week for a month. Motor imagery sessions were added on in the experimental group. Participants on the experimental group were asked to mentally imagine themselves recreating tasks they had performed earlier on the initial assessment. For the analysis of the results, descriptive and inferential statistics were used. The T-test for independent samples, and the T-test for paired samples were applied.

Eligibility Criteria:
Inclusion Criteria:

* institutionalized individuals
* individuals with disabilities who were able to perform motor tasks

Exclusion Criteria:

* individuals with hearing disability
* individuals with visual disability
* individuals without motor autonomy
Biomarkers That Predict Response to High-Dose Aldesleukin in Metastatic Kidney Cancer or Metastatic Melanoma

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers that predict response to high-dose aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.

OBJECTIVES:

* Determine the relationship of peripheral blood lymphocyte phenotype pattern in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose aldesleukin (IL-2).
* Determine the relationship of peripheral blood mononuclear cells gene microarray patterns in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose IL-2.
* Determine the frequency of mutations on genes encoding for IL-2 receptor A and B.

OUTLINE: Patients receive high-dose aldesleukin (IL-2) as part of standard treatment on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline, prior to beginning course 2, and 4 weeks after the completion of course 2. Samples are analyzed using peripheral blood cytometry, gene microarray analysis, and IL-2 receptor single-nucleotide polymorphism techniques.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic renal cell carcinoma or metastatic melanoma
* Must be receiving treatment with high-dose aldesleukin as part of standard therapy

Exclusion Criteria:

none
Feeling of Being in Control of One's Own Action

The investigators aim is to understand the cognitive mechanisms that contribute to the emergence of delusions of control (the belief that one's own actions or thoughts are controlled by an external force). These symptoms are mainly encountered in patients with schizophrenia, and the investigators will distinguish patients with schizophrenia with or without this symptom together with patients with bipolar disorder. Based on the investigators previous studies, this project will help to determine the role of two elementary mechanisms in the ability to feel in control of voluntary actions: (1) the processing of the sensory consequences of action, and (2) the ability to build mental representations for sequenced actions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia or bipolar disorders (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
* 18-55 years old

Exclusion Criteria:

* Past history affecting CNS
* Invalidating sensory disorders
* Intake of psychotropic drugs, except for patients
* Intake of benzodiazepines
Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp

To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)

When the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. Patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. Better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. In cases with necrotic pulp, the incidence of pain becomes higher, hence testing which intracanal medication is more effective in decreasing the bacteria present within the root canal and subsequently pain is crucial.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
* Non-pregnant females
* Asymptomatic necrotic mandibular single rooted teeth.
* Normal occlusal contact with the opposing teeth.
* Patients accepting to participate in the study.

Exclusion Criteria:

* Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
* Pregnant women: Avoid radiation exposure, anesthesia, and medication.
* If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception
* Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation Teeth that shows:
* Association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
* Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
* No restorability: Hopeless tooth.
* Vital teeth
* Immature teeth
* Radiographic evidence of external or internal root resorption.
* Any criterion, not mentioned in the inclusion criteria
Medtronic Signia SDR Product Surveillance Registry

The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic, abdominal, and pediatric applications, intraoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
* Patient has, or is intended to receive or be treated with, an eligible Medtronic product
* Patient is consented within the enrollment window of the therapy received, as applicable

Exclusion Criteria:

* Patient who is, or is expected to be, inaccessible for follow-up
* Patient is excluded by local law
* Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

This study will determine the effectiveness of a nutraceutical in treating the lingering effects of Lyme Disease after antibiotic treatment.

A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome will be evaluated during a double blind, placebo controlled study. This study is an expansion of RLP042019 NCT04078841 Treating Post-Lyme Disease Syndrome With Acetogenins

Eligibility Criteria:
Inclusion Criteria:

1. A positive two-test methodology using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.
2. Must be able to swallow a mixed powder drink.

Exclusion Criteria:

1 .Non Positive Western Blot test.

2. Positive Western Blot test where the individual has not been treated with antibiotics.

-
Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes

This study evaluates the association between testosterone levels and risk of dementia and adverse mental health outcomes (e.g. depression and anxiety). It is not known whether low testosterone levels may be associated with an increased risk of dementia. Learning about the association between testosterone levels and risk of dementia may help determine the long-term effects of androgen deprivation therapy and may help improve quality of life.

PRIMARY OBJECTIVE:

I. To use a Mendelian randomization study design to determine whether genetically predicted decreased testosterone levels are associated with an increased risk of dementia.

SECONDARY OBJECTIVE:

I. To examine whether genetically predicted decreased testosterone levels are associated with worse cognitive function and adverse mental health outcomes.

OUTLINE:

Patients' records from institutional or national biobanks are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Have volunteered to participate in institutional or national biobanks, mainly the UK Biobank and the Kaiser Permanente Research Bank, and those that have previously participated in studies that resulted in de-identified clinical and genetic data being make available on public archives, mainly the database of Genotypes and Phenotypes (dbGaP)
* No special populations (adults unable to consent, individuals not yet adults, pregnant women, or prisoners)
The Effect of a Structured Personalised Ergonomic Intervention for Hospital Nurses With Musculoskeletal Complains

The purpose of this study is to examine the effect of a structured personalised ergonomic intervention program for hospital nurses with musculoskeletal complains.

In a randomised controlled trial 31 nurses with musculoskeletal complains were observed at work, and an intervention program was completed in 14 nurses with the other 17 acting as controls. The intervention included four meetings during three months. Outcome measures were collected before the intervention and post-tests were gathered three months after the determination of the program.

Eligibility Criteria:
Inclusion Criteria:

* A minimum of half-time work for at least one year
* musculoskeletal pain complaints
* agreement to participate in the interventional study.

Exclusion Criteria:

* Male nurses
* nurses with previously defined job restrictions and
* pregnancy