cyrilzakka/clinical-trials huggingface dataset:
A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

The purpose of this study is to evaluate the safety and preliminary antitumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of Ewing sarcoma and have progressed on or after standard therapies.
* Must not be a candidate for potentially curative therapy or standard-of-care approved therapy.
* Measurable disease by computed tomography or magnetic resonance imaging based on RECIST 1.1 as determined by site radiology.
* Eastern Cooperative Oncology Group performance status 0 to 2.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Receipt of anticancer medications, anticancer therapies, or investigational drugs within protocol-defined intervals before the first administration of study drug.
* Must have recovered (≤ Grade 2 or at pretreatment baseline) from adverse events (AEs) from previously administered therapies except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
* Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
* Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non-CNS disease with medical monitor approval.
* Laboratory values outside the protocol-defined range at screening.
* History or evidence of bleeding disorder or active clinically significant bleeding requiring medical intervention.
Effect of Inspiratory Muscle Training on the Performance of Handball Athletes

This study investigated the effects of an inspiratory muscle training (IMT) program on the respiratory muscle strength and resistance and the aerobic physical performance (PP) of handball athletes. Nineteen male athletes took part in the study, allocated at random into the experimental group (EG, n=10) and the placebo group (PG, n=9), aged 19±1 and 22±5 years old, respectively. The respiratory muscle strength (RMS) was evaluated by measuring the maximum inspiratory and expiratory pressures (MIP and MEP, respectively), the muscular respiratory resistance was evaluated by maximum voluntary ventilation (MVV) and the aerobic PP by applying the cardiopulmonary exercise test. Subsequently the volunteers were submitted to an IMT protocol 5 times a week for 12 weeks.

The study was designed to evaluate the effects of a 12-week IMT program on the respiratory muscle strength and aerobic physical performance of handball players. Nineteen male athletes took part in the study, divided into the experimental group (EG), which took part in the evaluations, maintained their regular sporting activities and carried out the IMT (n=10), and the placebo group (PG), which took part in the evaluations, maintained their regular sporting activities and carried out an IMT with a load considered to be placebo (n=09), Experimental procedures were carried out by trained researchers and a qualified team. The evaluations and IMT were carried out during the competitive season, the training frequency being based on the competition program, following the traditional annual model.

The athletes were submitted to an initial evaluation composed of measuring the respiratory muscle strength (RMS) using a manovacuometer, and an evaluation of the aerobic physical performance carried out using the cardiopulmonary exercise test (CPET).

The athletes were reevaluated after 12 weeks for subsequent analysis and comparison with the initial values.

All the subjects were previously informed about the experimental procedures, and signed a free and clarified term of consent. The project was approved by the Ethics in Research Committee of the Institution with the number 62/13.

Eligibility Criteria:
GENDER: Male

AGE LIMITS:

Minimum age: 18 years Maximum age:30 years Accepts Healthy Volunteers? YES

Eligibility Criteria

Inclusion criteria:

* male gender
* competition level athlete for at least one year
* regularly takes part in the training sessions

Exclusion criteria:

* smoke
* shows signs of respiratory and/or cardiovascular diseases
* use supplements and/or medication that influences physical performance
EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER

This study is designed to compare the effectiveness of a closed suction system with an inflatable balloon on the catheter (Cleansweep system) to that of a standard closed suction system in terms of reducing the interior resistance of endotracheal tubes. Subjects who require frequent suctioning ( \> every 2.5 hours) and who have stable cardiovascular systems will be randomized to receive suctioning either through the Cleansweep system or standard system initially followed by the corresponding system. The subjects will be suctioned every two hours for eight hours ( the first 2 suction procedures with one system followed by 2 with the other system). After each suction procedure measurements of resistance will be made using peak and plateau pressures.

Analysis: For each patient, data for both procedures on each catheter system will be pooled and mean differences between the standard system and the Cleansweep system will be calculated. For all 20 patients the mean (+/- SD) of these differences will be calculated and significance will be sought using appropriate statistical tests. The study will be unblinded and randomization determines merely which system will used initially for the first 2 procedures.


Eligibility Criteria:
Inclusion Criteria:

* Intubated, mechanically ventilated patients who require suctioning more often than every 2.5 hours

Exclusion Criteria:

* Unstable cardiovascular system (significant arrythmias, blood pressure support requiring \> 2 pressors
* refractory hypoxemia (P/F ratio \< 80)
The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.

This clinical, randomized, and controlled study will provide valuable scientific evidence regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle surgery. In particular, the investigators want to determine if the need for postoperative opioids will be reduced and whether this will lead to shorter admission to recovery room and fewer instances of side effects such as postoperative nausea and vomiting. In addition, the investigators will determine whether the functional outcome is improved i.e. faster and more successful rehabilitation. This would have profound benefits not only to the individual patient but also to society by reducing expenses during admission, the cost of sick leave etc.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients in need of anaesthesia for operative fixation of ankle fractures.
* American Society of Anesthesiologists (ASA) score 1-3.
* BMI \> 18 og \< 35.
* Oral and written consent

Exclusion Criteria:

* Weight \< 50kg
* Allergy towards drugs used in the study
* Patients for re-operation
* Other fracture at the same time
* Pregnancy
* Daily use of opioids within two weeks before operation
* Infection near the application site
* Patients in need of dialysis
* Patients with neuropathy in lower extremities
Improving Health Services for Veterans With Schizophrenia

Schizophrenia exacts a high toll on the lives of patients and their families and constitutes a major health care cost. VISN 5 has placed special emphasis on improving care for veterans with severe mental disorders, an effort recently recognized by the VA as a Program of Excellence in the Care of Seriously Mentally Ill Veterans.

Background:

Schizophrenia exacts a high toll on the lives of patients and their families and constitutes a major health care cost. VISN 5 has placed special emphasis on improving care for veterans with severe mental disorders, an effort recently recognized by the VA as a Program of Excellence in the Care of Seriously Mentally Ill Veterans.

Objectives:

This study is implementing a set of promising QOC methods for assessing QOC for schizophrenia in routine settings, using the evidence-based treatment recommendations developed under the AHCPR/NIMH-sponsored Schizophrenia Patient Outcomes Research Team (PORT).

Methods:

A random sample of 350 persons with a schizophrenia spectrum disorder is being drawn from the VISN 5 sites. Patients must have more than one outpatient contact during the preceding six months. Each subject will participate in two one-hour interviews, one at baseline and another six months later. An informant, psychiatrist, therapist, etc. will also be interviewed to help validate participant response.

Status:

Project work is ongoing.

Eligibility Criteria:
Inclusion Criteria:

Patients must be adults currently in treatment for an Axis I schizophrenia spectrum disorder (DSM295) at VA.

Exclusion Criteria:
Perimenopause and Menopause in Women With Spinal Cord Injury

A lot of information is known about how the perimenopause and menopause affects able bodied women. However there is very little information about how these affects women with spinal cord injury. This questionnaire study aims to collect information from women with a spinal cord injury on their experiences of going through the perimenopause and/or the menopause.

There is widespread knowledge and information about the perimenopause and menopause, its symptoms and treatment; all of this is for people without spinal cord injury (women will be used to denote all people who can or have undergone the perimenopause and menopause). There is paucity of data about this condition in women with spinal cord injury. These women are living longer lives and should be supported to live a healthy life.

Some studies have suggested that women with Spinal Cord Injury (wSCI) may undergo the perimenopause and menopause earlier than those without, however others have concluded that the age at the perimenopause and menopause is no different. wSCI may suffer less with vasomotor symptoms due to their ability to manage the symptoms of autonomic dysreflexia; however they may have more genito-urinary symptoms; also due to the need for self-catheterisation.

Hormone Replacement Therapy (HRT) has many benefits including reduction in risk of fractures by slowing down the development of osteoporosis, thereby reducing fracture risk and morbidity. Reduced mobility also puts them at an increased risk of cardio-vascular disease.

This study aims to gain information about these characteristics of the perimenopause and menopause in wSCI; the age at which they become menopausal and the most bothersome symptoms for them, treatment options offered to them as well as details of their spinal cord injury.

Eligibility Criteria:
Inclusion Criteria:

* • Patient is willing and able to give informed consent for participation in the study (or verbally confirm they wish to take part if someone completing on their behalf)

  * Who has undergone or currently experiencing the perimenopause or menopause
  * Aged 18 years old or older
  * Clinically diagnosed with a spinal cord Injury at least 3 months ago
  * Is either a) currently going through the perimenopause and menopause or b) has been through the perimenopause and menopause.

Exclusion Criteria:

* • Individuals who have yet to go through the perimenopause and/or menopause
The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients

The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil (PSO) supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients.

The main question it aims to answer is:

• Does PSO have a promising effect on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients?

Patients on regular hemodialysis who take PSO supplementation will be compared to those who don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile.

This study aims to investigate the effects of PSO supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients via assessment of IL-6, MDA, lipid profile, and kidney function tests.

Patients \& Methods:

Design: Prospective, randomized, Open label - controlled clinical trial.

Patients: A total of 56 patients on regular hemodialysis (HD) will be enrolled in the study. These patients will be randomly allocated into two equal groups:

* Group 1 (PSO group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "
* Group 2 (Control group): consists of 28 patients who will not receive the intervention.

Setting: Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt.

Blood samples will be taken in the dialysis unit and will be sent to Ain Shams University labs for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients older than 18.
* Patients undergoing regular HD for at least 3 months prior to enrollment.
* Not participate in any other clinical trials.
* Physically stable.

Exclusion Criteria:

* Patients taking antioxidant supplements prior to the study's two-month time frame.
* Patients with autoimmune, liver, cancer diseases and acquired immunodeficiency syndrome (AIDS).
* Sensitivity to pumpkin seed oil.
* Patients taking warfarin.
* History of drug or alcohol abuse.
* Pregnant or breastfeeding women and women with the possibility of getting pregnant.
* Smokers.
Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma

The purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and stimulates an immune response to patients' own cancer cells.

Patients with stage III or IV melanoma need to have at least one tumor mass of at least 2.5 cm (about 1 inch) diameter than can be removed for vaccine production. If the vaccine is successfully made and if the patient is eligible, the patient will be assigned to receive one of 4 doses of the vaccine, include one group that will receive a zero dose. All patients will receive injections of their vaccine as part of immune system testing and will receive low dose cyclophosphamide and BCG. Eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6 month period. Before and after vaccine administration, patients will be tested for immunity to their own melanoma cells by DTH testing, which is similar to a tuberculosis test. All side effects caused by the vaccine will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* stage III or IV melanoma at least one tumor mass of at least 2.5 cm diameter that can be excised to make vaccine good performance status

Exclusion Criteria:

* brain metastases need for steroids or other immunosuppressive drugs positive PPD tests positive test for HIV, hepatitis B (antigen), or hepatitis C other serious medical illnesses
Human Repeat Insult Patch Test of Wound Dressings

The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.

A single center, within-subject randomized study design in healthy adult subjects. Qualified subjects will complete three phases of the study (induction, rest and challenge).

Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older
* In good health, as determined by medical history and concomitant medication
* Able to comprehend and sign informed consent
* Unable to bear children or willing to use adequate birth control
* Willing and able to follow study directions, to participate in the study and to return for all specific visit

Exclusion Criteria:

* Subject pregnant, planning a pregnancy or lactating
* Diabetes (any type)
* Mastectomy involving removal of lymph nodes
* Clinically significant skin disease, including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
* Asthma or other severe respiratory disease requiring medication
* Self-reported immunological disorders including (but not limited to) HIV positive, AIDS, rheumatoid arthritis, and systematic lupus erythematosus
* Treatment of any type of cancer within the last two years or history of skin cancer in the test area
* Use of any of the following: topically applied products (e.g. medicals, lotions, creams, etc.) at the application site within 3 days of first application of test articles, immunosuppressive drugs within 30 days of first application of test articles, systemic or topical corticosteroids within 30 days of first application of test articles, and systemic or topically applied anti-inflammatory and antihistamine medications within 3 days of first application of test articles
* Participation in any patch test for irritation or sensitization within the last four weeks
* Participation in any investigational drug study within the last four weeks
* Damaged skin in or around the test sites which includes: sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfiguration
* Known sensitization to adhesives, bandages, or materials used in test articles
* Medical condition which, in investigator's judgment, makes the subject ineligible or places the subject at undue risk
Use of an Ocular Telemetry Sensor in Diamox Treated Patients

A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of glaucoma or ocular hypertension
* IOP of ≥ 15 mmHg.
* Patients of either gender.
* Older than 18 years.
* Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion Criteria:

* Patients not able to understand the nature of the research
* Patients under tutorship
* Corneal abnormalities in both eyes
* Subjects with contraindications for wearing contact lenses
* History of ocular surgery within the last 3 months
* Known hypersensitivity to Diamox® or to any of its excipients
* Pregnancy and lactation
* Simultaneous participation in other clinical research
* Patients with evidence of ocular infection or inflammation
* History of renal or hepatic impairment, hypokalemia and hyponatremia
Electro-acupuncture (EA) and Chronic Pelvic Pain (CPP)

Chronic pelvic pain (CPP) is a debilitating condition that affects over 1 million women in the United Kingdom. The annual healthcare costs are estimated at over £150 million. Proven interventions which include the use of analgesics or hormonal treatments are unsatisfactory in many cases.

The investigators believe that the meridian balance method (BM) electro-acupuncture (EA) treatment (which includes a Traditional Chinese Medicine Health Consultation \[TCM HC\]) may be helpful in the management of CPP. Studies on the mechanisms of EA have demonstrated an analgesic effect. A recent individual patient data meta-analysis on the use of acupuncture for four chronic pain conditions found a small statistically significant effect size when compared to sham acupuncture. The effect size was larger and statistically significant when compared to usual care controls. This meta-analysis, and other large studies, suggests that, in addition to this analgesic effect, the interaction between the patient and the healthcare provider also plays a role in its effect on painful symptoms.

Our hypothesis is that the meridian BMEA treatment alleviates pain, and improves physical and emotional functioning, in women with CPP.

The investigators plan to undertake a single centre pilot study to assess the feasibility of performing a future three-armed randomised controlled, parallel group design trial to determine the efficacy of the meridian balance method electro-acupuncture (BMEA) treatment in the management of women with CPP.

The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.

The secondary objectives are to determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, interventions and assessment tools.

The investigators aim to recruit 30 women with CPP in NHS Lothian over a 12-month period and randomise them to BMEA treatment, TCM HC or standard care (SC). Response to the intervention will be monitored by validated pain, physical and emotional functioning questionnaires at weeks 0 (baseline), 4 (end of study) 8 and 12. Focus group discussion to gain feedback on study experience will be conducted at the completion of the study.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pelvic pain longer than 6 months duration
* Average numerical pain score of at least 4 out of 10 in the previous week
* Able and willing to comply with intervention
* Women aged 18 and above

Exclusion Criteria:

* Pregnancy
* Malignancy
* Severe bleeding disorders (e.g. Type 2, 3 Von Willebrand disease)
* Severe needle phobia
* Taking anti-coagulants
* A history of seizure
* A pace-maker in situ
* Moderate to severe psychiatric illness (currently under the care of a psychiatrist)
* Had received electro-acupuncture and meridian balanced method within the last 6 months
Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed recurrent nasopharyngeal carcinoma
2. The recurrence time is more than 6 months from the end of radiotherapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. According to the TNM staging criteria of nasopharyngeal carcinoma (AJCC, 8th Edition, 2017), rT1, rT2, rT3, and rT4 patients who can be completely resected by surgery as assessed by the surgical team.
5. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement.
6. Given written informed consent.

Exclusion Criteria:

1. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
2. Has known subjects with other malignant tumors.
3. Has participated in other drug trials within 3 months of planned start of study treatment.
4. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
5. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
6. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
7. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
8. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
9. Has received a live vaccine within 4 weeks of planned start of study treatment.
10. Pregnancy or breast feeding.
11. Cannot complete regular follow-up.
12. Local recurrence of nasopharyngeal carcinoma with distant metastasis