cyrilzakka/clinical-trials huggingface dataset:
Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen

To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT).

Patient must have:

* Uninterrupted therapy with reduced-dose AZT 500 - 600 mg/day for at least 3 weeks before entry.
* Acceptable hepatic and renal function.
* AMENDED to delete the following sentence:
* Hematologic intolerance to full-dose zidovudine (AZT) (1000 - 1200 mg/day).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Concurrent, ineffectively controlled opportunistic infections.
* Extensive cutaneous and/or visceral Kaposi's sarcoma requiring systemic chemotherapy.
* Proteinuria of 2+ or greater.
* HIV encephalopathy.
* HIV wasting syndrome.
* New York Heart Classification III or IV.
* Uncontrolled angina pectoris.
* Evidence of clinically significant, multifocal uncontrolled cardiac dysrhythmias.

Concurrent Medication:

Excluded:

* Antiretrovirals other than zidovudine (AZT) or Betaseron.
* Chronic acyclovir therapy.
* Acetaminophen.

Patients with the following are excluded:

* Intolerance (hematologic or otherwise) to zidovudine (AZT) at a dose of 100 mg orally every 4 hours. AMENDED to:
* Intolerance at a dose of 500 to 600 mg/day.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or complete the study.

Prior Medication:

Excluded within 30 days of study entry:

* Cytotoxic chemotherapy.
* Prior therapy with alpha, beta, or gamma interferons.

Active drug or alcohol abuse.
Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors

The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors

This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.

Eligibility Criteria:
Inclusion Criteria:

1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements
2. The age of signing the informed consent is from 18 to 75 years old, regardless of gender
3. Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors
4. The ECOG score is 0 or 1
5. Expected survival ≥12 weeks
6. At least one measurable lesion according to RECIST v1.1 criteria
7. Good level of organ function
8. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods

Exclusion Criteria:

1. subjects with uncontrolled or active brain metastasis；
2. subjects with clinical significant lung disease;
3. subjects with history of autoimmune diseases;
4. Known active hepatitis B or C infection;
5. Subjects with severe cardiovascular and cerebrovascular diseases
6. Uncontrolled tumor-related pain
7. Severe infections that require intravenous antibiotic, antiviral or antifungal control
8. Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion
9. Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
10. Known allergic to any compound of SHR-A2102 or HRS-4642
11. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment
CD64 and Antibiotics in Human Sepsis

The purpose of the study is to find out whether CD64 expression on neutrophils measured by a new bedside test (LeukoDx) within 30 minutes is associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis.

In the present study, in critically ill patients with suspected infection undergoing application of antibiotics, CD64 and inflammatory plasma markers will be determined on days 1 to 4.

CD64 expression on the surface of neutrophils will be determined by fluorescence activated cell sorter (FACS) and with a new bedside test (LeukoDx).

The purpose of the study is to clarify:

1. Is CD64 expression on neutrophils associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis?
2. Is CD64 expression associated with distinct plasma parameters of inflammation?
3. Do the results of the gold standard CD64 determination by FACS correlate with those of a new bedside test (LeukoDx)?

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* critically ill adult patients
* sepsis
* SIRS
* initiation of antibiotic treatment
* patients \< 48 hours after admission on ICU

Exclusion Criteria:

* multiple admissions on ICU, (\>1 in last 2 weeks period)
* leukopenia \< 1 G/l
* and thrombocytopenia
* rhG-CSF or IFN-gamma therapy up to 1 week before inclusion
* participation in another study receiving drugs or biological within the preceeding 30 days
* recent longterm corticosteroid treatment
* HIV
* patients after organ transplantation treated with immunomodulating drugs
* pregnant patients or after delivery
* life expectancy \< 24 hours
* polytraumatized patients with reanimation on scene, or infest prognosis
* patients under high dose corticosteroids or chemotherapy
Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma

The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.

It is a clinical study multicenter, prospective, open label trial, uncontrolled and nonrandomized

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse.

CNS involvement must be demonstrated by:

* A positive ventricular or lumbar CSF cytology defined as CSF cell counts \> 5/µl (19/3 cells), obtained within 10 days prior to inclusion OR
* Characteristic signs and symptoms of neoplastic meningitis PLUS an MRI or CT scan indicating the presence of meningeal involvement. Patients with combined relapse in CNS and other locations may be included in case that systemic therapy with CNS active drugs (HDMTX;HDAC, Thiotepa) can be postponed for at least 2 weeks.
* Karnofsky \>60%
* Age \>18 years old
* Recovery from grade III/IV toxicities attributable to prior treatment with the exception of hematotoxicity.
* No severe heart, lung, liver or kidney dysfunction.
* The patient or guardian must be competent to provide informed consent and must provide written informed consent prior to the initiation of study procedures

Exclusion Criteria:

* Failure (as defined by no clearance of the CSF) to \> 1 dose of prior intrathecal MTX or cytarabine or triple (MTX, ARAC, dexamethasone) therapy
* History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine induced peripheral neuropathy is accepted)
* Prior CNS relapse \< 1 month before
* uncontrolled infection
* The patient must not be pregnant or breast feeding. If the patient is a female of child-bearing potential she must have a negative (urine or serum) pregnancy test and be using effective methods to prevent pregnancy
Postop Catheterization for Urinary Retention

This study investigates patient's preference and satisfaction with choice of catheterization after surgical urogynecological procedures.

Preoperatively, the enrolled patient receives information about risks and benefits of three ways of bladder catheterization as means of management of postoperative urinary retention. Based on this information, the patient chooses her preferred way of postoperative catheterization in case she experiences acute urinary retention after surgery. After the surgery, those patients requiring catheterization postoperatively evaluate their experience in a postoperative questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* All female patients who undergo urogynecological surgery procedures at NorthShore University HealthSystem and consent to participate

Exclusion Criteria:

* Patients who cannot read, comprehend, and write in English
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula

This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years;
2. Able to understand the purpose of the study, willing to participate and sign the informed consent, able and willing to accept the follow-up;
3. Indications of percutaneous transluminal angioplasty for target lesion: target lesion shows \>50% narrowing relative to adjacent normal vein diameter by angiography or ultrasound with one of the indicators listed in KDOQI vascular access guideline 2019 update Table 13.2.
4. Reference vessel diameter of target lesion from 3.0 mm to 8.0 mm.
5. Target lesion located from proximal to the anastomosis to the reflux vein at the distal end of the subclavian vein.
6. De novo or restenosis lesion.
7. Single or tandem lesion, length of which ≤ 60mm.

Exclusion Criteria:

1. Women who are pregnant, nursing, or planning to become pregnant during the study.
2. Patients who have accepted major surgeries within 30 days prior to the enrollment. (such as thoracic surgery, cranial surgery).
3. Patients who plan to accept major surgeries within 30 days after the enrollment. (such as thoracic surgery, cranial surgery).
4. Occlusion lesion or thrombosis.
5. Infected fistula or severe systemic infection.
6. Patients who suffer from central venous diseases.
7. Patients known to be allergic or contraindicated to contrast agents.
8. Patients who have participated in another clinical trial within 3 months prior to the study, or previous enrollment in this study.
9. Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation.
Prospective Evaluation of 68-Ga-prostate Specific Membrane Antigen (PSMA)-Positron Emission Tomograph (PET) and Early Prostatic Specific Antigen (PSA) Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy

This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy. Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to the prostate bed and thereafter be classified as either responders or non-responders depending on PSA response at fifth week of radiotherapy.

A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment week in order to identify cancer lesions in patients with poor PSA response. Patients with PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst patients with poor PSA response may be in need for additional therapy such as radiotherapy to lymph node metastases and/or boost fractions to local recurrence. Patients with more than 3 lymph node metastases or distant metastases will not receive any more radiotherapy, but individualized systemic therapy will be started.


Eligibility Criteria:
Inclusion Criteria:

* Histological evidence of prostate cancer in the radical prostatectomy specimen
* At least 2 rising PSA values, of which the last ≥ 0.15 ng/ml
* Tumor, regional nodes, metastasis (TNM): any T, N0/x, M0/x
* Age: 18 years or older
* World Health Organization (WHO) performance status 0-1
* Life expectancy \> 10 years
* Adequate laboratory findings: hematological: hemoglobin \> 90 g/L (may be transfused to maintain or exceed this level) absolute neutrophil count (ANC) ≥ 1,0 x 109/L, platelets ≥ 75 x 109/L hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN renal: creatinine ≤ 1.5 x ULN
* Signed written informed consent
* The patient must be able to comply with the protocol

Exclusion Criteria:

* Evidence of metastasis on imaging or in specimen (e.g. N1 at lymph-node dissection)
* Prior or ongoing treatment with hormones (antiandrogens, GnRH)
* Prior radiotherapy to the pelvis
* Previous malignancy other than prostate cancer and basalioma the past 5 years.
* Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure
* Severe pulmonary disease e.g. pulmonary fibrosis
* Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

In clinical trials for treatment of allergic rhinitis a significant reduction of the total symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous results in adults show that the assessment and monitoring del nasal fractional exhaled nitric oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis.

Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous solution) on the nasal inflammation marker (nFeNO).

Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep quality (Pittsburgh Sleep Quality Index, PSQI).


Eligibility Criteria:
Inclusion Criteria:

* history of allergic rhinitis for at least 1 year
* children aged 6 - 14 years
* Total Symptom Score (T5SS) more than 6 in the last 4 days before the screening visit

Exclusion Criteria:

* signs of acute respiratory infection
* systemic immunological and metabolic disease
* major malformations of the upper airways
* topical or systemic therapy with antibiotics, antihistamines and corticosteroids in the 30 days prior to the study
* patient active smoker
Trial on Profermin and Fresubin in Ulcerative Colitis

This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Active ulcerative colitis (SCCAI =\>5 and \<=11)
* Access to Internet

Exclusion Criteria:

* Stoma or intestinal resections
* Recent changes in UC medication
* Treatment with antibiotics
* Diabetes
* Celiac disease
* Lactose malabsorption
A New Treatment for Premature Ejaculation?

The aim of study is to determine if they can produce increases in the IELT using a masturbator in subjects with premature ejaculation, producing improvements in the quality and satisfaction of the sexuality of the patient.

From the assignment of the devices masturbation aid Flip Hole by the Japanese company TENGA® it was possible to begin to develop the study. To shape the patients sample was used to the active search of participants who met with the criteria of incorporation established for the participation in the study, from the publication of the study in different social media (Facebook, Twitter ...) and the review of the database of the Instituto Sexológico Murciano patients' (ISM) who had represented previously with problems of premature ejaculation.

First interview with the participants was carried out where it informed them about the collaborative character in the study, together with the informed assent. To determine the suitability of the sample one administered ISM's Autobiographical questionnaire, the clinical Multiaxial Inventory of Millon-III (MCMI-III), and the Questionnaire of sexual satisfaction GRISS (Golombok Rust Sexual Inventory of Satisfaction), beside gathering a medical report of every patient to reject pathologies that they could interfere with the study.

Once established the number of participants, 15 males of ages included between 18 and 65 years, there was carried out a follow-up individualized for eight weeks from records of the IELT. During the first two weeks of research the subjects had to register the ejaculatory latency times during the manual masturbation and the intercourse being from the third week when they would use the device FLIP HOLE in the manual masturbation either alone or in company of the couple but never during the intercourse.

The subjects had to use the masturbator aid at least five times per week for six weeks, during a minimum of five minutes without never overcoming half daily hour and during intercourse. The device Flip Hole is a masturbation aid made from Thermoplastic Elastomer (a silicone like substance) that the user inserts their penis in to for stimulation.

The patients had to come weekly to ISM to deliver the weekly records and to be able to take a follow-up of the subjects along the process. Once finished eight weeks of the study one turned them to administer the questionnaire GRISS to evaluate if changes are produced in the sexual satisfaction of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Patient meets ISSM definition of PE
* Patient is 18 - 65 years

Exclusion Criteria:

* Patient has significant cardiovascular or neurological pathology.
* Patient has diabetes mellitus
* Patient is currently misusing alcohol/drugs
* Patient meets MCMI-III criteria for personality disorders and clinical syndromes
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.

Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival of 3-17% for inoperable disease. Staging has historically subdivided stage III disease into clinical stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to address optimal induction strategy.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologic diagnosis of non small-cell lung cancer
* Clinical stage IIIA and/or IIIB without pleural effusion
* ECOG functional status 0 or 1
* No renal function alteration (GFR \>50%)
* No hepatic function alteration (ALT and AST less than 2 times its normal value)
* Leucocytes more than 2,000/mcl
* Hemoglobin more than 10mg/dL
* Platelets more than 100,000/mcl

Exclusion Criteria:

* Active uncontrolled infection.
* Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
* MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
* Significant neurological or mental disorder.
* Second primary malignancy.
* Pregnant or nursing.
Exercise Induced Hypoalgesia Diabetes

The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects between the ages of 18 - 65.
2. Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose \> 126 mg/dL, or an oral glucose tolerance test \> 200 mg/dL.
3. Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
4. Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
5. Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.

Exclusion Criteria:

1. Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
2. Subjects with current or history of central nervous system disorders.
3. Subjects with resting hypertension (HTN) \>/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
4. Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
5. Subjects with Reynaud's disease or cold urticaria.
6. All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.
Strength-enhancing Effect of Whey Protein Supplementation Following Resistance Exercise in Adolescent Males

This study investigates the strength gains associated with resistance training in a group of 18 male high school athletes consuming either a whey protein supplement or chocolate milk following their exercise.


Eligibility Criteria:
Inclusion Criteria:

* member of Bellarmine Preparatory School boys sports team
* Must be willing to consume a post-exercise beverage

Exclusion Criteria:

* allergy to either beverage