cyrilzakka/clinical-trials huggingface dataset:
Antineoplaston Therapy in Treating Patients With Colon Cancer

RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with colon cancer.

OBJECTIVES:

* Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with adenocarcinoma of the colon by determining the proportion of patients who experience an objective tumor response.
* Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of oral antineoplaston A10 and oral antineoplaston AS2-1 6-7 times a day. If the patient has not achieved a partial or complete response after 3-4 months of treatment, the investigator may discontinue treatment. Patients with stable disease may continue to receive treatment until disease progression or unacceptable toxicity is observed.

Tumors are measured every 4 months during the first 2 years, then every 6 months during years 3 and 4, and yearly during years 5 and 6.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists
* Measurable disease by MRI or CT scan
* Metastatic or unresectable disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure

Renal:

* Creatinine no greater than 2.5 mg/dL
* No renal failure

Cardiovascular:

* No chronic heart failure
* No uncontrolled hypertension

Pulmonary:

* No serious lung disease, such as chronic obstructive pulmonary disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No active infection
* No serious malabsorption syndromes
* No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier)

Surgery:

* No prior extensive stomach or intestinal surgery

Other:

* Prior cytodifferentiating agent allowed
* No prior antineoplaston therapy
* No other concurrent anticancer therapy
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.

In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment.
* Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present.
* History of at least one therapy of platinum based chemotherapy.

Exclusion Criteria:

* Participation in another experimental drug study
* Heart disease or high blood pressure
* History of a stroke within the past 6 months
* Vascular disease, or bleeding problems
* Brain cancer
* Major Surgical Procedure within 28 days prior to start date
* Minor surgical procedures within 7 days prior to start date
* Pregnant or lactating
* Abdominal or bowel problems like bleeding
* History of abdominal fistula, GI perforation or Intra-abdominal abscess
* Serious, non-healing wound, ulcer or bone fracture
* Acute hepatitis
* Active infections requiring antibiotics
* Inability to comply with study or follow up procedures
Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months

The objective of this study was to measure the continued efficacy of apomorphine after previous exposure of at least three months duration.

This was a prospective, double-blind, randomized, placebo-controlled, crossover desigh, multicenter study of the safety and effectiveness of subcutaneous apomorphine treatment. Patients received both apomorphine and placebo, in a randomized double-blind fashion

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with idiopathic Parkinson's Disease and classified as stage II-IV of the Hoehn and Yahr scale for staging the severity of Parkinson's Disease
* Patients must have been on an optimally maximized oral therapy regimen including levodopa/decarboxylase inhibitors in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization
* Patients must have been receiving apomorphine subcutaneous injections for rescue therapy for "Off" events for at least three months with an average dosing requirement of at least 2 doses per day over the week prior to enrollment with a dose of less than 11 mg

Exclusion Criteria:

* Patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of antiparkinson medications. (Patients with hallucinations or other central adverse reactions associated solely with antiparkinson medications were not excluded.)
* Patients with a history of drug or alcohol dependency within one year prior to study enrollment
* Patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including Coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the threemonths before the start of the study.
* Patients with a history of allergy or intolerance to morphine or its derivatives, sulfur, sulfur containing medication, sulfites, domperidone, trimethobenzamide or other anticholinergics.
* Patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 3 months before study entry, experimental agents were defined on the basis of the regulatory status in the country of patient observation, or with other disallowed medications
* Patients whose apomorphine regimen was characterized by continuous infusion or by administration methods other than intermittent subcutaneous injection.
* Patients who could not or would not sign an informed consent form.
COVID-19 IgG Antibodies in the Serum of Recovered Patients

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which first appeared in China, in December 2019 and is now spreading worldwide and poses a great threat to public health. In 12th July 2020, the total number of cases worldwide was about 13 million cases with case fatality rate of 4.4% and in Egypt the total cases was 81158 and case fatality rate was 4.6%. (1,2).

In recent years, novel coronaviruses emerge periodically in different areas around the world. Severe acute respiratory syndrome coronavirus (SARS-CoV) occurred in 2002, which reportedly infected 8422 people with about 10% case fatality rate (3). Middle East respiratory syndrome coronavirus (MERS-CoV) was first identified in 2012 in Saudi Arabia, bringing a total of 1401 MERS-CoV infections, and about 35% case fatality rate (1). All the infection cases and recent epidemics show that coronaviruses impose a continuous threat to human beings and the economy as they emerge unexpectedly, spread easily, and lead to catastrophic consequences.

As the number of recovered patients with COVID-19 continues to be increasing, the strength and duration of immunity after infection is an important point to be studied. Moreover, understanding this issue is a critical point for controlling this epidemic as they are the key for herd immunity and for informing decisions on how and when to ease physical distancing restrictions and to be ready for other waves of the infection. There is currently no evidence if the people who have recovered from COVID-19 have antibodies and protected from a second attack of infection or future wave of this pandemic or not. Therefore, we will carry out a longitudinal study of immunity in recovered patients to assess SARS-Cov2 patients' risk for future reinfection.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 20 years.
* Prior COVID-19 infection confirmed by PCR detection of SARS-CoV-2 RNA or antigen in nasopharyngeal swab.
* Recovery from infection either confirmed by two consecutive negative PCR (collected ≥24 hours apart) or passing of 14 days since onset of COVID-19 symptoms and at least 3 days since resolution of fever without the use of antipyretics and improvement of respiratory symptoms

Exclusion Criteria:

* Presence of any chronic illness interfere with immunity (autoimmune diseases).
* Pregnancy.
* Recovery from three months or more.
Prospective Observational Cohort Study of Critically Ill Patients With Covid-19 in Sweden

The study will prospectively collect data from patients with Covid-19 admitted to the Västerås Intensive Care Unit, Västerås Hospital. Demographic, clinical, radiographic and laboratory characteristics will be recorded. Analysis of data to identify predictors of disease severity, mortality and treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Intensive Care Unit with biological samples positive for SARS-CoV-2.
* Patients admitted to the Intensive Care Unit with one or more negative tests but with clinical and radiological characteristics highly suggestive of SARS-CoV-2 and thus considered positive for the disease.

Exclusion Criteria:

* None.
Incidence of Infective Endocarditis in End Stage Renal Disease Patients on Hemodialysis by Transesophageal Echocardiography in Assuit University Hospital

1. To detect in more detail the incidence of infective endocarditis in patients with end stage renal disease (ESRD) on hemodialysis.
2. To compare the relationship between different forms of haemodialysis access type and the related incidence of infective endocarditis.
3. To determine individual risk factors, including type of vascular haemodialysis access, previous valve lesion and immunocompromised patients.

All patients will undergo TTE and TEE within 36 hours of symptoms. TTE will be performed with a 2.5- or 3.5-MHz phased-array transducer. Patients will fast for more than 4 hours before TEE, which will be performed under local pharyngeal anesthesia; the majority of patients will also receive intravenous midazolam (0.5 to 2.0 mg). A 5-MHz phased-array transducer (either biplane or multiplane) will be used for the transesophageal examination, which consisted principally of two-dimensional imaging and color flow mapping and will be performed without any complications in all patients.

All echocardiograms will be evaluated later during reading sessions by two observers. TTE studies will be defined as technically inadequate if both observers deemed the quality of the images to be insufficient to gain diagnostic information regarding the presence or absence of vegetations or their complications. Findings on TTE and TEE will be separately categorized as indicating high, intermediate, or low probability for endocarditis as follows: high, any definite vegetation and/or abscess or probable vegetation with evidence of otherwise unexplained valvular dysfunction (greater than mild regurgitation or a paravalvular prosthetic leak); intermediate, a probable vegetation without evidence of unexplained valvular dysfunction; and low, no evidence of vegetation or abscess or a possible vegetation without any evidence of regurgitation. 3 sets of blood culture with one hour interval will be withdrawn from the central line from all patients, before stating antibiotics within 24 hours from the onset of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Incidence of infective endocarditis in ESRD that on hemodialysis.
* Must be fit for Transoesophageal ECHO.

Exclusion Criteria:

* Any patient with sepsis due to causes other than infected vascular access.
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.


Eligibility Criteria:
Inclusion criteria:

1. Are ≥18 years of age at screening.
2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:

   * A CAS ≥ 4 in either eye, and
   * Clinical evidence of worsened proptosis with:

     * Proptosis ≥ 18 mm and/or
     * Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
4. Have onset of active TED within 12 months prior to screening.
5. Have documented evidence of detectable anti-TSHR-Ab at screening.
6. Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
7. Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

1. Have decreased best corrected visual acuity due to optic neuropathy.
2. Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.
3. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.
5. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
6. Had previous orbital irradiation or surgery for TED.

Additional exclusion criteria are defined in the protocol.
Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly orally and partly intravenous in advanced pleural mesothelioma.

Chemotherapy with carboplatin i.v. day one in each cycle Vinorelbine i.v. day one, and orally day 8 in each cycle, repeat new cycle every 3 weeks. Total of 6 cycles.

Endpoint is response rate, secondary endpoints survival and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified malignant pleural Mesothelioma
* Age above 18 years
* Performance status 0-2

Exclusion Criteria:

* No previous chemotherapy
* Normal renal, liver and bone marrow function
Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases

This phase III is designed to confirm the previous trial results evaluating the safety, clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines' adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic diseases.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases:moderate to severe hypertension, moderate to severe congestive heart failure, chronic obstructive pulmonary disease (COPD) or moderate to severe asthma, moderate to severe hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

Exclusion Criteria:

* Hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine;
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
* Known or suspected impairment/ alteration of immune function;
* Any condition which might interfere with the evaluation of the study objectives
A Study of MK0731 in Patients With Advanced Solid Tumors (0731-002)(COMPLETED)

The purpose of this trial is to study MK0731 in patients with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for whom standard therapy does not exist. Part of the study includes only patients who have taxane-resistant cancers.

Exclusion Criteria:

* Patients who have had treatment with any investigational therapy within the past 30 days.
* Patients who have certain types of blood cancers such as leukemia or lymphoma.
* Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation.
* Patient is pregnant or nursing.
Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer

This trial tests an online nutrition education program focused on decreasing nutrition-related side effects of chemotherapy in patients with breast cancer. Patients undergoing chemotherapy are at risk for complications such as diarrhea or constipation which can lead to poor nutritional intake and malabsorption of nutrients. This study is testing the effects of information delivered via the Cook for Your Life website in conjunction with standard clinical care to improve symptom management during chemotherapy treatment for breast cancer, which could serve as a new model for supportive oncology care.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current Cook for Your Life website.

ARM II: Patients receive standard of care as in Arm I and access to enhanced Cook for Your Life information on symptom management.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Stage I-III breast cancer.
* Current breast cancer patients scheduled to receive ddAC-T(+/-C), TCHP, or TCPembro-AC chemotherapy at Fred Hutch South Lake Union (can enroll prior to receipt of 2nd cycle).
* Not pregnant and no plan to become pregnant during chemotherapy treatment.
* Ability to speak and read English.
* Access to smartphone, tablet, or computer and Internet.
* Willing and able to complete all study activities through the end of chemotherapy, including completing online questionnaires and telephone assessments.
* Women must not be pregnant at time of enrollment based on self-report.
* Able to understand and willing to sign written informed electronic (e) consent in English.
Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol

Main objective:

Determine whether by introducing thromboelastograph, the investigators reduced the number of packed red cells received by each patient (median) compared to the usual protocol, in which the indication for transfusion is based on laboratory tests: Prothrombin time, time activated partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage.

Design:

Prospective randomized controlled trial and single blinded.

Disease or disorder under study:

Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Primary endpoint:

median transfusion of packed red blood cells per patient. Study population Male and female patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed excessively.

Duration of treatment:

The coagulation monitoring methods tested are made from protamine administration to CEC output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied critics a) bleed excessively drains and until the patient stops bleeding (debit drains \<a 150ml / h).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* over 18 years
* undergoing cardiac surgery
* with cardiopulmonary bypass
* bleed excessively

As it is not possible to predict in advance who will bleed, informed consent will be required for all patients over 18 who are to undergo cardiac surgery with CPB.

Will be randomized to either group

1. Those patients with diffuse bleeding after protamine administration. and / or
2. They bleed excessively after surgery. Are excessive bleeding criteria: the debit ≥ 300ml drains in the first hour; ≥ 250ml in the second hour or ≥ 150ml at any later time. Consider that the patient is bleeding excessively when the drains debit is \<150ml.

Exclusion Criteria:

* Patients \<18 years
* Extracorporeal circulation surgery
* Surgery with Mini extracorporeal circulation (MECC)
* Refuse to participate in the study.
Sexual Health Impact of Using Pre-exposure HIV Prophylaxis

Epidemiological and psychosociological survey of people on pre-exposure HIV prophylaxis (PrEP).

This study is perform to study the sexual health satisfaction of men who have sex with men (MSM), since the use pre-exposure HIV prophylaxis (PrEP), compared to the time before PrEP.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, male having sex with men, not infected with HIV, and using HIV prophylaxis by pre-exposure treatment (PrEP) for at least 1 year, received in consultation for renewal of this prescription.
* Able to give his non-opposition to participate in the research.
* Affiliation to a social security scheme.

Exclusion Criteria:

* Patient under curatorship/guardianship or safeguard of justice
* Refusal to participate
QOL in Incarcerated Inguinal Hernias: TAPP Vs Open Repair

To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic transabdominal pre-peritoneal (TAPP) or modified Lichtenstein hernioplasty

Patients presenting with incarcerated inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Both genders
* Unilateral inguinal hernias
* Incarcerated inguinal hernias
* Elective setting

Exclusion Criteria:

* Anaesthesiologists) Grade \> 2
* Recurrence
* Inguinal-scrotal hernias
* Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
* Pregnancy
* Refusal for general anaesthesia