cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis

Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to treat these conditions toxic therapies such as cyclophosphamide and steroids are often required. These standard treatments are associated with significant side effects. Furthermore a proportion of patient do not respond to these conventional therapies. Newer safer therapies are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one part of the human immune system that helps prevent infections. Abnormal activity of the immune system is responsible for autoimmune disease although the exact mechanisms in lupus and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this context. It has recently been used to treat some autoimmune conditions with positive results. In this pilot study we wish to assess the effectiveness and safety of rituximab in patients with lupus and vascultis that are resistant to conventional therpies.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of SLE or ANCA associated vasculitis
2. Active disease refractory to 6 months conventional therapy with cyclophosphamide, prednisolone and at least one other immunosupressive agent ( or a lesser period if this therapy cannot be tolerated)
3. Age 18-70

Exclusion Criteria:

1. HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this study)
2. Pregnancy, inadequate contraception or lactation
3. Malignancy
4. Current enrolment in pother clinicla trials -
A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

The goal of the project is to determine whether confocal endomicroscopy can be used to identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared with histologic specimens as a reference. The project will evaluate those at risk for or with known Barrett's esophagus, and those with known or suspected biliary strictures. It is our hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.

This study was amended from it's initial design to increase the number of patients to 200. The study was terminated in July 2016 after 106 patients were enrolled and had completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia
* Patients undergoing ERCP for known or suspected biliary strictures.

Exclusion Criteria:

* have a known allergy or have had a prior adverse reaction to fluorescent contrast agents or chromoendoscopy stains
* are younger than age 18 or who are mentally or legally incapacitated or unable to give informed consent
* are pregnant or breastfeeding
* patients with advanced esophageal cancer
* acute gastrointestinal bleeding
* coagulopathy
* impaired renal function
Innovations in HIV Testing

The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.

The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. In this study the investigators proposed two phases. The first phase, previously completed, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of HIV testing and HIV self-testing in the study population and 2) conducting observed HIV self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. The second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) CHOICE of self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.

Eligibility Criteria:
Eligibility Inclusion Criteria Index:

* Females ages 18-26
* Have had sex in the past 3 months and plan to have sex again in the next 3 months
* Planning on staying in the Agincourt Health and Demographic Surveillance System (AHDSS) area for the next nine months
* Able and willing to provide informed consent
* Willing to comply with study procedures
* Not known to be HIV positive (not reporting a previous positive test)

Eligibility Inclusion Criteria Peer/Partner:

* Females and Males ages 18 and older
* Able and willing to provide informed consent
* Willing to comply with study procedures
Study of the Effect of Glutamine Supplementation on Chemotherapy Induced Toxicities in Breast Cancer Patients

Glutamine, a non essential branched chain amino acid, is most important non toxic nitrogen carrier in body. It participates in variety of physiological functions. It is a major fuel source of enterocytes and is a substrate for gluconeogenesis in kidney, lymphocytes, and monocytes. It is also a nutrient in muscle protein metabolism in response to infection, inflammation and muscle trauma. The significance of glutamine to metabolic homeostasis becomes evident during periods of stress, when it becomes a conditionally essential amino acid. Role of glutamine as protective agent in hepato-biliary dysfunction, in maintaining mucosal integrity of the Gastrointestinal tract following its administration in patient with major bowel surgery as a supplement and part of TPN in critically ill patients and in patients of septicemia, is well established. However the role of glutamine supplementation in reducing or preventing chemotherapeutic agents induced toxicity in cancer patients is controversial.


Eligibility Criteria:
Inclusion Criteria:

* The patients \> 18 years of age
* Histologically or cytologically proven breast cancer
* Receiving CEF chemotherapy cycles presently or in the past
* The patients who will give informed consent to participate in the study
* Patients must have sufficient organ and marrow function
* Stage 1 neuropathy, subclinical neuropathy, surgery induced neuropathy

Exclusion Criteria:

* Pregnancy
* Clinical/biochemical severe liver failure
* Clinical/biochemical severe renal dysfunction
* Refusal to participate in the study
* Patients who have received prior chemotherapy with paclitaxel.
* Patients who have neuropathy due to any known systemic or metabolic causes like diabetes, leprosy, nutritional deficiency induced (vit. B12) etc
Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer

The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline

This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as first line treatment in women with MBC

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed metastatic breast adenocarcinoma.
* No previous chemotherapy treatment for metastatic disease.
* No previous anthracycline treatment except as adjuvant therapy at least one year before.
* Age 19-75 years old
* Presence of measurable disease
* Performance status 0-2 (WHO)
* Adequate cardiac function (LVEF \>50%) without a recent (within 6 months) history of myocardial infraction and/or unstable or uncontrolled angina.
* Adequate bone marrow(absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3), liver (bilirubin \<1.5 times upper limit of normal and SGOT/SGPT \<2 times upper limit of normal) and renal function (creatinine \<2mg/dl).
* No previous radiotherapy to more than 25% of marrow-containing bones.
* Written informed consent

Exclusion Criteria:

* Active brain metastases.
* Psychiatric illness or social situation that would preclude study compliance
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except of nonmelanoma skin cancer.
* Positive pregnancy for premenopausal women.
* Concurrent antineoplastic treatment e.g. hormonal therapy
Cervical Rippening With Antiprogesterone in Midtrimester Abortions

Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip.

The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects.

Eligibility Criteria:
Inclusion Criteria:

* midtrimester late abortion
* midtrimester induced abortion

Exclusion Criteria:

* placenta previa
* infected abortion
* rupture of membranes
* s/p cesarean section \*2 or more
Preventing Mental Disorders Among Women Internally Displaced by War in Ukraine: The SHAWL Trial

This study is a randomized controlled trial among 120 recently displaced women to determine the effectiveness of a single-session Acceptance and Commitment Therapy (ACT) group therapy on prevention of development of mental health disorders or worsened mental health symptoms.

The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, one-third of Ukrainians have been forced to leave their homes, resulting in upwards of 7 million internally displaced persons. Estimates suggest that 60% of Ukraine's displaced persons are women, who face stressors including difficulty accessing necessary primary health and psychological care, restricted access to food and stable housing, and increased strain from separation from their social networks and additional family care responsibilities.

Early reports from Ukraine consistently describe the psychological distress that displaced women are presently experiencing. It is anticipated that nearly one in five people exposed to conflict will develop mental disorders, notably depressive and anxiety disorders. Thus, improving access to mental health prevention programs that mitigate development of mental disorders for women in Ukraine is critical.

This study will adapt a community-based Acceptance and Commitment Therapy (ACT) intervention to prevent the development symptoms of depression and anxiety among women displaced by war in Ukraine. ACT is an evidence-based approach that uses acceptance, mindfulness and behavioral change processes to improve psychological flexibility. Recently displaced women who screen positive for symptoms of depression and anxiety will be recruited. The investigators plan to adapt and evaluate a single-session ACT group intervention to limit effects of mental health distress among these displaced women.

The central hypothesis of this research is that an ACT-based intervention delivered in a humanitarian context will help displaced women in Ukraine learn skills to improve psychological flexibility, thereby decreasing symptoms of depression and anxiety and ultimately mitigating onset of mental disorders.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Identify as a displaced woman within one year of migration
* Endorsing mild to moderate depressive symptoms (subscale score between 3 and 7) and/or anxiety symptoms (subscale score between 2 and 6) on the Mental Health Assessment Inventory (MHAI) but not exceeding the maximum score for either subscale (i.e., not exceeding 7 on the depressive symptoms subscale and not exceeding 6 on the anxiety symptoms subscale)
* Ability to provide informed consent
* Speak Ukrainian or Russian

Exclusion Criteria:

* Diagnosis of a depressive or anxiety disorder, or symptoms necessitating urgent referral for evaluation of suicidal or homicidal ideation
* Receipt of psychiatric care for depression or anxiety in the past 5 years
* A severe medical problem that inhibits ability to participate in the trial
Prospective Evaluation of a Commercially Available Hydrogel Spacer

Dosimetry efficacy evaluation of the hydrogel spacer

Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Males
* At lease 18 years of age
* Undergoing external beam or brachy radiation therapy with a hydrogel spacer

Exclusion Criteria:

* Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension
Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses

The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (60-70Gy Vs.\>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 18≤Age≤75 years
* Cytologically or histologically verified pancreatic adenocarcinoma or clinically diagnosed as pancreatic cancer by multidisciplinary consultation
* locally advanced pancreatic cancer (LAPC)
* SBRT was not preceded by any targeted antitumor therapy
* ECOG 0-1
* Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures

Exclusion Criteria:

* Patients who have previously received related treatment because of pancreatic adenocarcinoma, such as radiotherapy, chemotherapy or focal treatment
* Patients with severe liver or kidney dysfunction
* Patients with obstructive jaundice
* Patients with mass ascites
* Patients participated in other clinical trials for less than three months
* Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, ect
* Unsuitable to participate in this clinical trial judged by the investigator
Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function

As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties.

The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular:

* LDL oxidation
* HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided written consent
* Patients with national health insurance cover

Patients with T1D

* T1D Patients treated with insulin via a pump or multiple injections
* HbA1c \< 9.5 %

Control patients

* Normal fasting glycaemia (\< 6.1 mmol/L)
* Age \> 18 years, matched for sex and age with T1D patients

All patients

* Normal serum HDL cholesterol (\> 1.04 mmol/L in men, \> 1.30 mmol:L in women)
* Serum LDL cholesterol \< 5 mmol/L
* triglyceridemia \< 1.7 mmol/L
* Waist circumference \< 102 cm in men, \< 88 cm in women

Exclusion Criteria:

* Smoking
* Kidney failure (Creatinine clearance\< 60 ml/min/1.73 m2)
* Liver failure
* Dysthyroidism
* Medication that interferes with lipoprotein metabolism (lipid-lowering agents, oestroprogestative, anti-HIV, corticoids, retinoic acid), unless stopped for at least one 1 month
* Antioxidant (vitamin E, dietary supplements, DHA)
* Pregnancy of more than 15d
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\].

Eligibility Criteria:
Inclusion Criteria:

* Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
* Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
* Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
* Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
* Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator

Exclusion Criteria:

* Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject
* Poor compliance with the visit schedule or medication intake in the previous brivaracetam study
* Pregnant or lactating women
* Participation in any clinical study of another investigational drug or device during the study
Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief

The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome.

Carpal tunnel syndrome (CTS) is a collection of symptoms and signs associated with median neuropathy at the carpal tunnel. Most CTS is related to idiopathic compression of the median nerve as it travels through the wrist at the carpal tunnel.

Corticosteroid injection is an extensively used and accepted treatment in mild to moderate CTS according to the guidelines of the American Academy of Orthopedic Surgeons as corticosteroids reduce the inflammation and edema associated with CTS. However, there is no guideline as to which corticosteroid has to be used as the standard treatment in CTS.

Triamcinolone acetonide, a commonly used steroid for this indication, is a particulate steroid, which can cause permanent nerve injury if accidentally injected into the nerve.

Local ozone injection as a therapeutic option in some musculoskeletal conditions; ozone (O3) gas is a molecule consisting of three oxygen atoms in a dynamically unstable structure. Ozone therapy has been utilized and studied for more than a century.

Eligibility Criteria:
Inclusion Criteria:

* Age from 20 to 60 years.
* Both sexes.
* Patients with ultrasonographic evidence of mild-to-moderate carpal tunnel syndrome (CTS).
* Inclusion criteria will include numbness and pain in the median nerve (MN) distribution persisting for minimum of 3 months , nerve conduction studies (NCS) consistent with carpal tunnel syndrome (CTS) as per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines, and an median nerve (MN) cross-sectional area (CSA)at the wrist \>12 mm2 suggesting mild-to-moderate CTS forms.

Exclusion Criteria:

* Patient refusal.
* Patients with severe symptoms and signs of CTS as identified per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines,\[14\] as this is an indication for surgery,
* Patients who show improvement on medical treatment,
* Previous surgical or injectional CTS treatment,
* Pregnancy ,co existence of brachial plexopathy, or thoracic outlet syndrome, polyneuropathy, radiculopathy and peripheral nerve lesion in upper limb.
* Severe cardiovascular disease
* Morbid obese patients (body mass index (BMI) of \>35 kg/m2)
* Infection at site of injection.
* Bleeding diathesis.
* History of thyroid deficiency, uncontrolled diabetes mellitus , rheumatoid arthritis and history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
* History of Ozone or Dexmedetomidine allergy.
* End stage renal and hepatic disease.
* History of inflammatory joint , connective tissue disorders, , burns, any local tissue contractures and history of wrist trauma.
* Patients who will not consent to completing The visual analogue scale (VAS) for pain or nerve conduction study before and after injection.
Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients

This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

See above

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 y. old, non or ex-smokers for \> 6 months
* Mild to moderate asthmatic in general good health
* On either low-dose inhaled corticosteroid or steroid naive
* No other asthma medication
* Regular sputum producer
* EOS more than 3% at randomization,
* FEV1 \> 70%

Exclusion Criteria:

* Respiratory infection within last 4 weeks
* Any condition that may affect the conduct of the study as per the investigators
Interventions for Sleep Problems in Early Childhood

This study will inform the field about underlying mechanisms associated with infant sleep problems and will deepen the understanding of the intervention process. The study will provide detailed information on the intervention process itself and will explore how behavioral sleep interventions affect broader infant outcome.


Eligibility Criteria:
Inclusion Criteria:

* infants at age range 9-18 months;
* healthy infants with no significant health problems;
* two-parents families;
* parents who master the Hebrew language.
* significant sleep problem lasting more than 3 months:

Our definition for a significant sleep problem in this age range is based on meeting at least one of the following three criteria for the baseline week:

* an average of three or more night-wakings per night;
* an average wake period of at least 30 minute per night between sleep onset and morning rise time;
* more than 30 minutes to fall asleep each night with protests for attention.

Exclusion Criteria:

* Infants not meeting the inclusion criteria at the baseline assessment will be excluded from the study.