cyrilzakka/clinical-trials huggingface dataset:
Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed

Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of the cancer cells. Combining thalidomide and interferon alfa may kill more tumor cells.

OBJECTIVES:

I. Determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma.

II. Evaluate the toxicity of thalidomide in these patients. III. Assess the use of interferon alfa in patients who develop disease progression while being treated with thalidomide.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed hepatocellular carcinoma OR
* Diagnosis of hepatocellular carcinoma based on characteristic mass and alpha-fetoprotein greater than 500 in the setting of known cirrhosis or chronic hepatitis B or C
* Measurable disease

  * At least 20 mm in one dimension
* Not amenable to curative surgical resection

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Hematopoietic:

* Absolute neutrophil count greater than 1,200/mm\^3
* Hemoglobin at least 8.0 mg/dL
* Platelet count at least 25,000/mm\^3

Hepatic:

* Bilirubin no greater than 5 mg/dL
* Liver function tests no greater than 5 times normal

Renal:

* Creatinine no greater than 1.5 mg/dL

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Regardless of fertility status:

  * All women (unless they have undergone hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception AND 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study
  * All men (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study
* No other medical condition that would preclude study
* No other prior malignancy in past 5 years except curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No more than 1 prior biologic therapy regimen
* No prior interferon or thalidomide for hepatocellular cancer

Chemotherapy:

* No more than 1 prior chemotherapy regimen

Other:

* No concurrent barbiturates or alcohol
Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts

Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.

The experimental arm is only sentinel node identification + radical hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older,
* Absence of contraindication to laparoscopy,
* Uterine cervical carcinoma (every histological type except neuroendocrine),
* Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),
* Negative pregnancy test for women able to procreate,
* Having the French National Social Security
* Signed informed consent

Exclusion Criteria:

* Neuroendocrine carcinoma,
* In situ carcinoma or stage IA1 without LVSI,
* Maximal tumoral diameter measured by MRI more than 4 cm,
* Stage IB1 by "down-staging",
* Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,
* Presence of distant metastases,
* Progression of the cervical cancer or recurrence,
* History of pelvic lymphadenectomy,
* Other cancer diagnosed during the course of treatment,
* Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide,
* History of severe allergy (history of Quincke's edema, anaphylactic shock),
* Patient who does not understand, speak or write the French language,
* Pregnant woman
A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery

The purpose of this study is to help us to better understand the effects of two different types of surgical techniques on pain and quality of life in patients with precancerous lesions or early stage mouth cancers.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven diagnosis or clinical diagnosis of any benign oral cavity lesion. Pre-surgical biopsy will not be required if lesion is suspected to be benign.
* Biopsy proven diagnosis or clinical diagnosis of premalignant oral cavity lesions (leukoplakia, erythroplakia, lichen planus, dysplasia)Pre-surgical biopsy will not be required if lesion is suspected to be benign.
* Biopsy proven diagnosis of small superficial oral cavity SCC (stage T1N0) requiring resection without the need for neck dissection.
* All pathology will be reviewed at MSK to confirm diagnosis.
* The lesion plus the resection margin should not exceed 4.0 cm circumferentially.
* Planned to undergo surgical treatment by resection without flap reconstruction and without neck dissection.
* All patients age 18 years of age and older.
* Karnofsky performance score over 60.

Patients on blood thinners (aspirin or Coumadin) will be asked to stop medications 7 days prior to surgery. In the case of Coumadin, patients are switched to lovenox 7 days prior to surgery and this is stopped the day before surgery. Following surgery aspirin or Coumadin are recommenced 48 hours postop.

Exclusion Criteria:

* Patients with previous Head and Neck radiation
* Pregnant or lactating female patients.
* Patients with oral cavity squamous cell cancer requiring neck dissection
Mat Pilates Versus General Exercises for Patients With Nonspecific Acute Low Back Pain

Aim: To compare the effectiveness of Mat Pilates with General Exercises in treating patients with nonspecific acute low back pain.

Novelty: Pilates, typically performed with specific equipment, has shown clinically significant treatment effects in people with chronic low back pain. Recent guidelines recommend patients remain active during episodes of low back pain; however, evidence regarding the type of exercise to perform is limited. Mat Pilates is a type of Pilates exercise that does not require complex equipment. Evaluating the effectiveness of two simple exercise methods (Mat Pilates and General Exercises) can help expand intervention options for patients with acute low back pain, enabling them to choose an exercise they enjoy most.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 50 years old
* Acute nonspecific low back pain with at least 3 points on the Visual Analog Scale (VAS)
* Willing and able to provide informed consent
* Able to comply with the study protocol and attend all treatment sessions and follow-up assessments

Exclusion Criteria:

* Presence of specific low back pain causes, such as lumbar radiculopathy, spinal stenosis, or spondylolisthesis
* Previous spinal surgery
* Contraindications to exercise, such as severe cardiovascular or respiratory conditions
* Currently pregnant or planning to become pregnant during the study period
* Participation in another clinical trial or receiving concurrent experimental treatment for low back pain
AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

In this study, the investigators will explore the feasibility of ex vivo drug screening to predict sensitivity to chemotherapy resistance and to identify novel synergy between chemotherapies.


Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
* Peripheral blood blasts \> 1%
* Peripheral white blood cell count \> 1,000/µl.
* Age ≥ 18 years
* Anticipated treatment with any of the following regimens (Cohort 0) or:

  * Cohort 1: A standard induction protocol with infusional cytarabine
  * Cohort 2: Decitabine (either 5-day or 10-day regimens)
  * Cohort 3: Azacitidine (either intravenous or subcutaneous administration)
  * Cohort 4: Decitabine (either 5-day or 10-day) + venetoclax
  * Cohort 5: Azacitidine (either intravenous or subcutaneous administration on 7 day or 5+2+2 schedule) + venetoclax
* Patients may receive these therapies as part of other on-going clinical trials or as standard of care treatment.
* Patients in Cohort 1 may receive SOC midostaurin or gemtuzumab ozogamicin, provided these start after the Day 2 sample is collected. Patients in Cohort 1 may receive a standard combination of cytarabine/idarubicin, cytarabine/daunorubicin, or Vyxeos, a liposomal formulation of cytarabine and daunorubicin.
* ECOG performance status ≤ 3
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Pregnant or currently nursing
* Prior chemotherapy with hypomethylating agents
* Known history of positive HIV serology.
* Known positive Hepatitis C serology.
* Patient must not have received any chemotherapy within 7 days of enrollment, and any acute treatment-related toxicities must have returned to baseline. Patients may have received hydrea as long as they fulfill peripheral blood blast and peripheral WBC inclusion criteria. Prior TKI therapy is allowed, but must be discontinued within 3 days of baseline blood collection.
* Currently receiving any other investigational agents.
Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19

The aim of this study is to reduce pulmonary complications in adult patients undergoing abdominal or thoracic surgery in COVID-19 exposed hospital environments. A Trial in Low and Middle Income Countries (LMICs)

This trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new therapeutic options to the platform. This will enable rapid feedback of results to clinicians, allowing the standard of care to be modified as the pandemic progresses. Regular and frequent monitoring of results will be guided by an experienced, independent DMC.

Eligible patients will be randomised at the level of the individual in a 1:1 ratio between:

A. Control (normal practice) B. RESP301 6ml mixture of 150mM sodium nitrate, 50mM mannitol and 100mM citric acid, buffered at pH 5.4, three times per day (at least 4 hours apart), for 7 days or until discharge, whichever occurs first

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over. (This criteria MUST be made country-specific)
* Planned to undergo abdominal or thoracic elective or emergency inpatient surgery requiring general anaesthesia.
* Asymptomatic of COVID-19, including patients with: those not tested, negative test results, positive test but no symptoms (to be monitored post-surgery for symptoms)
* Informed patient consent.
* Able to operate a vibrating mesh nebuliser, as assessed by the recruiting physician

Exclusion Criteria:

* Procedures under local anaesthesia
* Known history of adverse reaction/contraindication to trial drug
* Pregnancy and/or lactating patients (including patients undergoing caesarean section)
* History of methaemoglobinaemia
* Patients receiving any type of prescribed nitric oxide-donating agents (e.g. Nitroprusside, Isosorbide dinitrate, Isosorbide mononitrate, Naproxcinod, Molsidomine and Linsidomine)
* Unable to tolerate use of a nebuliser and/or deemed unlikely to be able to adhere to protocol in view of investigator
Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria

In 2013 in France, 29,000 people are reported to be unaware of their HIV status. HIV testing is a priority in France where one third of all diagnoses remain late despite 5 million annual tests. It is recommended to offer at least one HIV test to the general population, over the life course, when seeking care and more frequently to populations at risk. Several international and national articles have shown that emergency screening is feasible and well accepted. But also that during systematic screening few infections were discovered, and the majority of newly diagnosed people belonged to the most exposed groups.

Our hypothesis is that an electronic alert would identify people who are unaware of their HIV status. This alert would be based on two data: social data (French health coverage) and the country of birth. This alert is only relevant in high-prevalence regions, as is the case in the Ile de France region.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized at Foch Hospital over 18 years of age.
* Patient with AME or CMU and/or CMUc, or patient born in one of the following countries/regions: Sub-Saharan Africa, Haiti, South America, Asia, Eastern Europe, Guadeloupe, Martinique and Guyana

Exclusion Criteria:

* Patient whose vital prognosis at the time of admission does not allow him/her to indicate his/her non-opposition to an HIV test.
* Patient being followed for a known HIV infection.
Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the zotarolimus eluting stent (ZES) and to determine clinical device and procedural success during commercial use of ZES.

The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm) with 1st generation ZES (Endeavor Sprint, retrospective arm).


Eligibility Criteria:
Inclusion Criteria:

* The patient agrees to participate in this study by signing the informed consent form.
* Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Exclusion Criteria:

* There are no exclusion criteria for this registry.
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers

The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.

Recombinant tuberculosis allergen (RTA) is a recombinant fusion protein CFP10-ESAT6 produced by the prokaryotic cell line. The test is widely used in Russian Federation and CIS countries for the latent TB diagnosis in adults and children over 8 years old. The current clinical study is a prospective, multicenter, open-label study in the cohort of healthy adults, not classified as at risk of tuberculosis, with no clinical symptoms of the disease, with a negative T-SPOT.TB test results, to evaluate the specificity of the RTA test in 72 hours following administration of the product at a dose of 0.2 μg/0.1 mL.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent for the participation in the study.
2. Age 18 to 30 years
3. A history of BCG vaccination (confirmed by medical documentation and/or the presence of BCG scar)
4. Healthy individual according to physical examination and medical records at screening.
5. Willingness to cooperate and follow the recommendations of the Investigator in accordance with the Protocol.

Exclusion Criteria:

1. A history of tuberculosis or close contact with a patient with active tuberculosis for 5 years prior to the enrollment in the study.
2. Positive T-SPOT.TB test at the enrollment in the study
3. Treatment with drugs affecting immune system within 3 months prior to the enrollment in the study
4. Vaccination against any infections \<1.5 months prior to the enrollment in the study
5. Vaccination with BCG \<6 months prior to the enrollment in the study.
6. The Mantoux test with 2 TU and/or the test with the recombinant tuberculosis allergen was performed less than 6 months prior to the enrollment in the study.
7. Congenital or acquired immunodeficiency.
8. Active disease of the immune system
9. HIV infection.
10. The current condition of the skin interferes with the conduct and reading of skin tests (trauma, skin diseases).
11. A disease in which blood sampling poses a risk to the volunteer (hemophilia, other bleeding disorders) or obstructed venous access.
12. The volunteer currently participates in another clinical study or has participated in another clinical study within 3 months prior to the enrollment in the study.
13. Previous participation in clinical studies of ESAT-6 and/or CFP-10 antigens.
14. Pregnancy, lactation, pregnancy planning.
15. The reluctance of a female person to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptives during the study.
16. History of alcohol, drug, benzodiazepine, or other substance abuse within the 12 months prior to the enrollment in the study.
17. Use of alcoholic beverages within 24 hours prior to the visit.
18. A condition or disease that, in the opinion of the Investigator, is inappropriate for participation in the study.
Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, expanded cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 40 to 75;
* Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1\<70% predicted value and FEV1/FVC \< 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination.);
* Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year;
* Tolerant to bronchofiberscope;
* Written informed consent signed.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients positive for syphilis, HIV;
* Patients with malignant tumor;
* Patients with serious significant pulmonary infection and need anti-infection treatment;
* Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
* Patients with a history of abusing alcohol and illicit drug;
* Patients participated in other clinical trials in the past 3 months;
* Patients assessed as inappropriate to participate in this clinical trial by investigator.
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.

This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP
* Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and wound status for at least 3 days
* The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
* Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial after administration of trial product, except interruption due to inclusion in this pathfinderTM 3 trial (NN7088-3860)
* The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. (For Brazil, only: Participation in a previous clinical trial within one year prior to screening for this trial (Visit 1), unless there is a direct benefit to the research subject, at the Investigator's discretion)
* FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening
* Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
* Immune modulating or chemotherapeutic medication
* Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's judgement, could imply a potential hazard to the patient, interfere with trial participation or trial outcome
* Unwillingness, language or other barriers precluding adequate understanding and/or cooperation
Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)

This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy females 16 to 23 years of age
* Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study
* Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred)

Exclusion Criteria:

* No prior receipt of an Human Papillomavirus (HPV) vaccine
* No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment
* No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy showing cervical intraepithelial neoplasia (CIN)
* No prior history of genital warts or treatment for genital warts