cyrilzakka/clinical-trials huggingface dataset:
L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma

The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. This study plan to include stage III or IV unresectable or metastatic cutaneous or acral malignant melanoma patients, treat with L-TIL 4 cycles with each infusion (3 -10) x10\*9/m2 cells, combined with tislelizumab 200mg, iv, Q3W. It is expected that 30 patients will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination 3. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection.

8. Other tumor disease.

Exclusion Criteria:

1. Symptomatic brain metastases
2. Active infection
3. Active HBV or HCV infection
4. HIV infection
5. Autoimmune disease
6. Sensitive to drug or ingredients
7. Severe mental disorders
8. Sever disfunction of heart, liver and kidney
Total30 Sphere Contact Lenses

The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.

Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

Eligibility Criteria:
Inclusion Criteria:

* Current contact lens wearers who have 20/20 visual acuity or better
* Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10)
* Astigmatism better than or equal to 0.50 D in each eye
* Must have regularly worn 2 week or monthly contact lenses within the past 6 months
* Must provide a glasses prescription that is is less than 3 years old
* Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day

Exclusion Criteria:

* Past or Current hard CL use
* Any known systemic health conditions that are thought to alter tear film physiology
* History of viral eye disease
* History of ocular surgery
* History of severe ocular trauma
* Active ocular infection or inflammation
* Currently using isotretinoin-derivatives
* Currently using ocular medications
* Currently using rewetting drops or artificial tear
* Pregnant or breast feeding
Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP

This international, multi-center, double-blind, randomized, controlled clinical trial aims to evaluate the efficacy of Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as treatments of Phantom Limb Pain (PLP). In PME, myoelectric pattern recognition (MPR) is used to predict motor volition and then use the decoded movements to control virtual and augmented reality environments (VR/AR), along with serious gaming (SG). The same device and VR/AR environments are used in PMI with the difference that subjects will imagine rather than execute phantom movements. Electromyography is used to monitor for no muscular activity in PMI.

Sixty-six subjects with upper or lower limb amputations are planned to take part in this study. Subjects will be assigned randomly to PME and PMI treatments (2:1 proportion). After treatment completion (15 sessions of 2 hours each) and follow-up period of six months, patients that received PMI will be given the choice to receive PME. The design is double blinded as the patient will be informed that the treatment received, regardless of which, has been shown effective in previous studies. The person conducting the pain evaluations will be blinded to which treatment each patient receives, and will not take part on providing treatment (evaluator and therapist are different persons).

Eligibility Criteria:
* Subject must be older than 18 years.
* If the subjects are under pharmacological treatments, there must be no variations on the medicament dosages for at least one month (steady consumption).
* The last session of previous treatments must be at least 3 months old.
* Any pain reduction potentially attributed to previous phantom limb pain treatments must be at least 3 months old.
* Subjects must have control over at least a portion of biceps and triceps muscles for upper limb amputations, and quadriceps and hamstrings for the lower limb amputations.
* The subject has signed a written informed consent.
* The subject must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis) or being a non user.
* At least six months should be passed since the amputation: acute phantom limb pain cases should not be included in the study.
* The patient subject should not have a significant cognitive impairment that prevents the patient from following instructions.
* Subjects with abundant soft tissue on their stump will not be automatically excluded, however, an evaluation in the system is required to analyze if sufficient electromyography signals can be recorded.
* Subjects for whom skin contact or muscle contraction are painful (NRS \> 2) are not eligible for the study.
* The subject should not have any condition associated with risk of poor protocol compliance.
* The subject should not have any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgement.
An Interactive Informed Consent and Education Program for Pregnant Women

The purpose of this study is to determine whether an interactive education program for prenatal testing is effective in improving pregnant women's understanding of and expectations towards prenatal screening and diagnosis.

Women face a variety of medical decisions during pregnancy and childbirth. While there are extensive educational resources for pregnant women, modern medicine presents decisions that many women are poorly equipped to make. Issues such as prenatal screening and mode of birth after a cesarean delivery require a significant degree of patient education to enable a truly informed medical decision. Studies have shown that women have a poor understanding of screening for birth defects and mode of birth after a cesarean delivery. Women with a low level of education or poor health literacy are significantly more likely to demonstrate inadequate understanding of prenatal screening. ArchieMD, Inc. has developed a comprehensive interactive medical simulation environment which has the potential to visually convey complex information to patients to improve understanding of medical procedures and educate patients on the consequences of their behavior. We hypothesize that such an interactive medical simulation patient education program can improve patient understanding allowing pregnant women to make informed decisions. In Phase I, we will prototype an interactive patient education program for prenatal screening and amniocentesis.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman (6-26 weeks gestation)
* Over 18 years of age

Exclusion Criteria:

* Non-English speaking
A Study of Family-integrated Care for Reducing Uncertainty

To explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. The study will be described the feeling of parents of premature infants after family participation nursing through interview. We will provide support for families of premature infants, and then to provide support for growth and development of premature infants.

Most of the current management mode of restricting or forbidding visiting in neonatology, parents can not establish the perception of premature infants and lack of communication with medical staff, which will lead to negative emotions represented by uncertainty of disease.The research on uncertainty of disease started late in China, mostly used in tumor, epilepsy and congenital heart disease. The research on parents of NICU children mostly focused on the analysis of influencing factors of uncertainty of disease, lacking intervention research, and the measures were only the information support mode based on health education. We want to explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. Describe the feeling of parents of premature infants after family participation nursing through interview. We will provide support for families of premature infants, and then to provide support for growth and development of premature infants.

Eligibility Criteria:
Inclusion Criteria:

Children:

* 32 weeks \< gestational age \< 37 weeks
* Birth weight ≤ 2500g
* Apgar score \> 7
* Transferred to our hospital within 8 hours after birth

Parents:

* Have normal communication ability and understanding ability
* Agreed to participate in this study

Exclusion Criteria:

Children:

-With serious life-threatening diseases, the neonatal critical cases score (discussion draft) was rated as "extremely critical"

Parents:

-There are serious diseases or major negative events in the family (such as traffic accidents, natural disasters, etc.)
PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy

The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who are not receiving chemotherapy or radiation therapy.

This was an open-label (doctors and patients knew which drug was being administered), non-randomized (patients were assigned to treatment), multi-center pilot study with the objective to investigate the effectiveness of PROCRIT (Epoetin alfa) on hematopoietic response (effect on red blood cells) when administered at 60,000 Units subcutaneously (under the skin) every two weeks in anemic patients with cancer who were not receiving chemotherapy or radiation therapy.

Treatment with study drug was for a maximum of 12 weeks followed by a 4-week observation period after the last dose of the study drug had been administered.

Safety and efficacy evaluations were performed at specified intervals throughout the study and included assessment of laboratory tests (Complete Blood Count \[CBC\], Serum Chemistry \[including hemoglobin level\]), vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events. All patients enrolled in this study received pharmacologic ferrous sulfate 325 mg by mouth once a day or an equivalent formulation, as tolerated, unless it was determined by the physician that the patient should not receive it. All patient's received injections of PROCRIT (Epoetin alfa) 60,000 Units under the skin once every two weeks. If after 4 weeks of treatment, the patient's hemoglobin level did not increase by \>= 1 g/dL, the Epoetin alfa dose was increased to 80,000 Units every 2 weeks. Study drug was administered for a maximum of 12 weeks followed by a 4-week observation period after the last dose of study drug. Epoetin alfa doses were reduced or held as needed depending on the patients' hemoglobin level.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed diagnosis of non-myeloid malignancy
* Baseline hemoglobin value of \<= 11 g/dL unrelated to transfusion
* Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
* Female patients with reproductive potential must have a negative serum pregnancy test at screening.

Exclusion Criteria:

* Patients must not have uncontrolled hypertension or a history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
* No transfusion within 28 days prior to first dose
* No planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
* No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months.
Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease

IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor specific antibodies to reduce the antibody load and thus enable kidney transplantation. IdeS antibody reducing efficacy and its safety will be studied.

Study 13-HMedIdeS-02 (EudraCT no. 2013-005417-13) is a single centre, single arm, dose finding, Phase II study in sensitized CKD patients assessing safety, tolerability, pharmacokinetics (PK) and efficacy of HMED-IdeS without intent to transplantation. However, patients are not removed from the transplant waitlist during the study. Included patients has a panel reactive antibody \[PRA\] \>70% (n=7).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic kidney disease and in dialysis with identified antibodies against at least two HLA antigens of which at least one is 3000 MFI or more as measured by SAB assay on at least two occasions.

Exclusion Criteria:

* Prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer Gleason \<6 and prostate-specific antigen (PSA) \<10 ng/mL.
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV
* Clinical signs of ongoing infectious disease.
* Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> New York Heart Association (NYHA) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (COPD)
* History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
* Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to IdeS (e. g streptokinase and/or staphylokinase)
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study. Patients consented and screened but not dosed in previous studies are not excluded
Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia

The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Age 18-80 years of age
* Surgery that is expected to last at least 2 hours under general anesthesia with endotracheal tube

Exclusion Criteria:

* Any subject that meets the definition of vulnerable subject as defined in ISO 14155:2011
* Per ISO 14155:2011, a vulnerable subject is defined as an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate
* Any subject with a cardiac pacemaker
* Any subject with atrial fibrillation at the time of obtaining the baseline values
* Any subject with more than 5 ventricular extra systoles/minute at the time of obtaining the baseline values
* Any subject who needs invasive blood pressure measurement
* Any subject who show hemodynamics that would have qualified for being considered as a sign of inadequate anesthesia already at baseline:
* Mean blood pressure below 60 mmHg or above 100 mmHg
* HR below 45 /min or above 100/min
* Any subject with epidural anesthesia or analgesia during the surgery. Epidural catheter may be placed pre-operatively, and used in the PACU, but not during the surgery
* Any subject having surgery that requires prone position
* Any subject with very high body mass index (\>35) because of incompatibility with the target controlled anesthesia models used
* Any subject with known allergies to the specific anesthetic agents/ analgesic drugs intended for use in their surgeries
* Any subject with laryngeal mask airway
* Any subject who requires neuromuscular blocking agent infusion
* Any subject who is going to have major surgery with a high risk of extensive blood loss
* Any subject with known chronic use of opioids
Screening for Memory Studies

We hope to recruit participants into various clinical trials and research projects.

The purpose of this protocol is to advertise, recruit, and do a preliminary screen for various clinical trials. Anonymous information collected will be entered in a database available to researchers connected with the Stanford/VA Aging Clinical Research Center, located at VA Palo Alto Health Care System, Palo Alto Division.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 or over.

Exclusion Criteria:

* Major psychiatric problems.
* Major medical problems.
* Aversion to test-taking.
Strength Training in Children With Cerebral Palsy

This study was set out to assess the effect of stretch-shortening (SSC) exercises on gait-symmetry and balance in children with unilateral cerebral palsy (UCP). Forty-two children with UCP were randomly allocated to the control group (n = 21, received standard physical rehabilitation) or the SSC group (n =21, received standard rehabilitation plus SSC exercises). Both groups were assessed for ait-symmetry and balance pre and post-treatment.

Forty-two children with UCP were recruited from the Physical Therapy Outpatient Clinic of Collee of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 8 and 12 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, attentional neglect, cardiopulmonary problems preventing them from performing high-intense exercise training.

Outcome measures

1. Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through a 3D motion analysis system.
2. Balance capabilities: several aspects of balance including sensory organization, reactive balance, and rhythmic weight shift were tested through a Pro Balance Master system.

The control and SSC groups received a standard rehabilitation program for 45 minutes, twice a week for eight consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. Additionally, the SSC group received an SSC exercise program for 30 minutes, twice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The SSC program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The SSC training was preceded by a warm-up for 5 minutes and ended up with a 5-min cooldown.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral cerebral palsy
* age from 8 to 12 years
* motor function level I or II according to the Gross Motor Function Classification System
* Spasticity level 1 or 1+ according to the Modified Ashworth Scale

Exclusion Criteria:

* Structural deformities
* Musculoskeletal or neural surgery in the last year
* BOTOX injection in the last 6 months.
* cardiopulmonary disorders interfering with the ability to engage in exercise training
* hemispatial neglect
Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic

Alcohol abuse is associated with a variety of clinical diseases, but studies on prevalence of different somatic diseases among alcohol abusers are lacking. Studies on populations in an out-day patients' clinic are also lacking.

The investigators aim to study somatic health standard in an out-day patients' clinic population of alcohol abusers, with regard to prevalence of different kinds of somatic diseases, and how the interaction of somatic and psychiatric treatment can influence on patients quality of life. Clinical examination including blood samples and echocardiographic examinations in all participants, other additional examinations (as x-ray, CT or MRI if indicated by clinical findings).

Retrospective methods will be used to study former somatic disease, cross-section design to study present somatic disease and prospective design to study quality of life, psychiatric and somatic health after combination of psychiatric and somatic examinations and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol abusers reffered to the out-day patients' clinic at Dep. of Psychiatry, Levanger Hospital, Norway

Exclusion Criteria:

* Not consenting to participate
* Not able to consent