cyrilzakka/clinical-trials huggingface dataset:
Yoga in Treating Sleep Disturbance in Cancer Survivors

RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.

OBJECTIVES:

Primary

* Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs \> 5). Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion.
* Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any type of cancer
* More than 1 primary cancer allowed
* Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
* Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
* Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
* Able to read English
* 21 years of age or older

Exclusion Criteria:

* No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
* No diagnosis of sleep apnea
* No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab \[Herceptin®\])
* No metastatic cancer
The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes

The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic variability, oxidative stress, and endothelial function in patients with type 2 diabetes.

Recently, improved understanding of the incretin effect on the pathophysiology of type 2 diabetes has led to development of new agent for hypoglycemic therapy. Vildagliptin is a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor that augments the active glucagon-like peptide(GLP)-1 concentration, increases insulin secretion and improves glucose tolerance. Vildagliptin has a similar glucose lowering effect, but lower hypoglycemic events, as compared to glimepiride. Vildagliptin could improve not only the mean glycemic control but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin and glucagon secretion. Furthermore, decreased postprandial glycemic excursion might reduce the oxidative stress markers and improve endothelial dysfunction. Those effects might be amplified in Asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. In addition, GLP-1 and GLP-1 analogues exert direct beneficial effects on endothelium-dependent vasodilatation. Therefore DPP-4 inhibitors may directly improve endothelial dysfunction.

Based on this assumption, this research will focus on the effect of vildagliptin on glycemic variability, oxidative stress markers and endothelial cell function compared to long acting sulfonylurea glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with hemoglobin A1c levels within the range 7% - 10%
Emergency/Compassionate Use - AMPLATZER Duct Occluder

Emergency/compassionate use for the AMPLATZER Duct Occluder


Eligibility Criteria:
Inclusion Criteria:

* Emergency/compassionate use for patients not meeting the inclusion crtieria for the AMPLATZER Duct Occluder clinical trial
Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars

The aim of the clinical trial is to assess pain during Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-mechanical Caries Removal (CMCR) in primary molars.

The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques"high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia.

In ART, soft carious tissue is removed by hand instruments. Although this technique is very simple.

Moreover, Smart Burs are more efficient in removal of soft infected dentine than ART leaving the affected dentin intact; as when they touch hard dentin, they become dull.

Finally, the recent effective method of caries removal is CMCR. The chemical agent contains proteolytic enzyme which destructs partially degraded collagen, leaving the infected dentin soft and easy to be excavated.

Therefore, the aim of this study is to assess pain during Atraumatic Restorative treatment, Smart Burs and Chemo-Mechanical Caries Removal in primary molars.

Eligibility Criteria:
Inclusion Criteria:

* Caries in second primary molars within enamel/ dentin without pulp disease.
* There is a clear band of dentin coronal.
* Cooperative and healthy children.

Exclusion Criteria:

* Presence of signs and symptoms of necrosis.
* Root caries.
* History of spontaneous pain.
Sensitivity of Self-collected Skin Sampling for Scabies: a Pilot Study

In this cross-sectional diagnostic study, healthy adults aged 18 and older with suspected, clinical, or confirmed scabies will be recruited. The objective is to determine if the sensitivity of self-collected skin samples for scabies diagnosis is non-inferior to professional sampling, and compare the sensitivity and specificity of the polymerase chain reaction assay (PCR) versus microscopy.

Scabies infestations have significantly increased globally in the last 10-20 years, including a threefold rise in the Netherlands over the past decade. Diagnosing scabies is challenging due to varied symptoms and low sensitivity of current microscopic methods. New diagnostic techniques like PCR, which offer higher sensitivity, are being investigated. The feasibility of self-collected skin samples is being explored to reduce the burden on healthcare services and address issues like autonomy, stigma, and privacy.

In this cross-sectional diagnostic study, healthy adults aged 18 and older with suspected, clinical, or confirmed scabies will be included. Primary endpoint is the sensitivity of self-collected versus professional skin samples for diagnosing scabies. Secondary endpoints include sensitivity of skin scrapings and swabs, and the sensitivity and specificity of PCR versus microscopy.

Participants will self-collect skin samples during a standard care visit. The process may be slightly sensitive but not painful. There are no direct benefits beyond standard care.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Have either suspected scabies, clinical scabies or confirmed scabies (see table 1)
* Providing informed consent (IC)

Exclusion Criteria:

* Individuals not speaking or understanding the Dutch or English language.
* Individuals who have been diagnosed with scabies in the last six weeks and had started treatment.
* Individuals who have used ivermectin for other diagnoses than scabies in the last six weeks.
* Individuals younger than 18 years.
* Individuals with immunosuppressive conditions (see appendix A).
* Any other condition, finding or situation which, in the opinion of the investigator, may significantly increase the risk to the individual because of participation in the study, affect the ability of the individual to participate in the study or impair interpretation of the study data.
APRIL CAR T Cells (AUTO2) Targeting BCMA and TACI for the Treatment of Multiple Myeloma

The purpose of this study is to test the safety and efficacy of AUTO2, a CAR T Cell Treatment Targeting BCMA and TACI, in Patients with Relapsed or Refractory Multiple Myeloma.

The study will consist of 2 phases, a Phase I/dose escalation phase and a Phase II/expansion phase. Patients with relapsed and relapsed or refractory multiple myeloma will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in order to harvest T cells, which is the starting material for the manufacture of the autologous CAR T product AUTO2. AUTO2 has a dual target BCMA (B cell maturation antigen) and TACI (Transmembrane activator and calcium modulator and cyclophilin ligand interactor). Following pre-conditioning by a chemotherapeutic regimen, the patient will receive AUTO2 intravenously as a single or split dose and will then enter a 12-month follow-up period.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female patients, aged ≥ 18.
2. Willing and able to give written, informed consent.
3. Confirmed diagnosis of MM.
4. Measurable disease as defined by IMWG.
5. Relapse or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor, alkylator and immunomodulatory therapy (IMiD), or have "double refractory" disease to a proteasome inhibitor and IMiD.
6. For females of childbearing potential, a negative serum or urine pregnancy test must be documented at screening and confirmed before receiving study treatment.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
8. Peripheral blood total lymphocyte count \> 0.5 x 10⁹/L.

Key Exclusion Criteria:

1. Women who are pregnant or lactating.
2. Prior treatment with investigational or approved gene therapy or cell therapy products.
3. Patient has previously received an allogenic stem cell transplant.
4. Clinically significant, uncontrolled heart disease or a recent (within 6 months) cardiac event.
5. Left Ventricular Ejection fraction \< 50 unless the institutional lower limit of normal is lower.
6. Significant liver disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN, or total bilirubin \> 2.0 mg/dL or evidence of end stage liver disease (e.g. ascites, hepatic encephalopathy).
7. Chronic renal impairment requiring dialysis, or calculated creatinine clearance \< 30 mL/min
8. Active infectious bacterial or viral disease (hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human T-lymphotropic virus or syphilis) requiring treatmenUse of rituximab within the last 3 months.
9. Active autoimmune disease requiring immunosuppression.
10. Received any anti-myeloma therapy within the last 21 days prior to preconditioning or 10 days prior to leukapheresis; steroids of up to 160 mg of dexamethasone are permitted so long as \> 7 days post-dose prior to pre-conditioning or leukapheresis.
11. Known allergy to albumin, dimethyl sulfoxide (DMSO), cyclophosphamide or fludarabine.
Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins

The study consists to Identify viral variants involved in the transmission of hepatitis C and characterize the antigenic and functional properties of their envelope glycoproteins at very early stage of infection (before seroconversion).


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* agree to participate in this study (signing the consent form or information form signed and letter of no objection for subjects contaminated by blood exposure).

These criteria are specific to contaminated subjects:

* primary infection before development of HCV antibody (seroconversion): nucleic acid testing positive in the absence of HCV antibodies.

These criteria are specific to individual sources :

* HCV antibody positive.

Exclusion Criteria:

* refusal to participate
* private about freedom
* under guardianship
* under justice
* minor or major person unable to consent
Isoflavones for Promoting Calcium Absorption and Preventing Bone Loss in Post Menopausal Women

Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide protection against bone loss. This study will evaluate the effect of soy isoflavones on calcium absorption and bone loss in post menopausal women.

Estrogen is a hormone that activates bone-forming cells and prevents calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may accelerate bone breakdown and inhibit the body's ability to create new bone, thereby leading to bone loss and possibly osteoporosis. Various treatments have been developed to decrease bone loss in post-menopausal women. Actonel, for example, is an FDA-approved drug used to help prevent bone loss.

Phytoestrogens are plant compounds with a structure similar to estrogen. They have also been shown to help reduce the negative effects of menopause. Isoflavones are a particular type of phytoestrogens that are found in soy plants and may act like estrogen in providing possible protection against bone loss. This study will compare the effects of isoflavones (including genistein, a type of isoflavone) versus Actonel on calcium absorption and bone loss in post-menopausal women.

Participants in this double-blind cross-over study will first complete a screening process, which will include answering questions about their health habits, medical history, physical activity, and food patterns. They will then eat one soy bar daily for 3 days. On Day 4, a urine sample will be taken to assess their ability to metabolize phytoestrogen from soybeans. Participants will be randomly assigned to a specific treatment order. Participants will receive 1-4 unique soy isoflavones, followed by Actonel. Treatment phases will be separated by a 50-day washout period. All participants will also take calcium and vitamin D supplements throughout the study. Assessments will include bone density measurements, calcium absorption tests, and blood and urine tests. The study will last approximately 2.5 years.

Eligibility Criteria:
Inclusion Criteria:

* At least 4 years post-menopausal

Exclusion Criteria:

* Not currently taking estrogen replacement therapy or undergoing any treatment for osteoporosis
* Diagnosis of breast cancer
* Results of mammogram suggesting breast cancer
Pediatric Nevirapine Resistance Study

This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP) -based regimen is effective for the treatment of HIV-infected children when previous NVP exposure has occurred as part of programs to prevent mother-to-child transmission (pMTCT).

The wide use of NVP in pMTCT-prophylaxis may result in resistance to NNRTI and concomitantly limits the use of these drugs for the treatment of HIV-infected children. To avoid restricting treatment options for children, it is desirable to preserve NVP for both pMTCT and first line treatment. This study will therefore test whether resistance-caused treatment failures of HIV-infected and previously NVP-exposed children can be avoided if the NVP treatment is preceded by an initial PI-based regimen.

Comparison: HIV-infected children less than 24 months of age, exposed to any pMTCT regimen that included NVP and who achieve and maintain viral suppression for at least 3 months with a PI-based regimen will be randomized to one of the two groups: (1) to continue on PI-containing regimen or (2) to be switched off the PI-containing regimen onto the NVP-containing regimen. The study outcome will be proportions in the two groups who have complete virologic suppression at 6 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

* NVP-exposure as part of pMTCT-prophylaxis around delivery
* HIV-positive
* Eligible for treatment
* Plans to stay in the area for the next 6 months

Exclusion Criteria:

* Already on anti-retroviral treatment
* History of toxicity to perinatal NVP
* Grade 3 or greater elevation of liver function tests
* Being treated for a severe acute opportunistic infection or tumor
The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis

The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;
* Age ≥ 18 years-old;
* Capability of expressing informed consent;
* Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;
* Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;
* Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and/or golimumab);
* No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;
* At least 1 follow-up visit after baseline

Exclusion Criteria:

* Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
* Age \< 18 years-old;
* Incapability of expressing informed consent;
* Acute severe UC requiring hospitalization at baseline;
* No previous exposure to anti-TNFα therapies;
* Previous treatment with target therapies other than anti-TNF-α for UC before baseline;
* Ustekinumab or JAK inhibitors induction with a non-standard posology for UC.
Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours

Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.

The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.


Eligibility Criteria:
Inclusion criteria:

1. Patients with histologically or cytologically confirmed diagnosis of non resectable and / or metastatic cancer, preferably squamous cell carcinomas of head and neck, oesophagus, lung or cervix
2. Indication for a standard treatment with either cisplatin plus paclitaxel or cisplatin plus 5 FU as judged by the investigator
3. Age 18 years or older.
4. Life expectancy of at least three (3) months.
5. Written informed consent that is consistent with ICH-GCP guidelines.
6. Eastern Cooperative Oncology Group (ECOG) performance score less or equal 2.
7. Patients must have recovered from any therapy-related toxicity from previous chemo-, hormone-, immuno-, or radiotherapies.
8. Patients recovered from previous surgery.

Exclusion criteria:

1. Active infectious disease.
2. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea.
3. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
4. Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least four (4) weeks, no history of cerebral oedema or bleeding in the past four (4) weeks and no requirement for steroids or anti-epileptic therapy.
5. Cardiac left ventricular function with resting ejection fraction less than 50%
6. Absolute neutrophil count (ANC) less than 1500 / mm3.
7. Platelets count less than 100 000/mm3.
8. Bilirubin more than 1.5 x upper limit of institutional norm.
9. Aspartate amino transferase (AST) or alanine amino transferase (ALT) more than 3 x upper limit of institutional norm.
10. Serum creatinine more than 1.5 x upper limit of institutional norm.
11. Women and men sexually active and unwilling to use a medically acceptable method of contraception.
12. Pregnancy or breast-feeding.
13. Treatment with other investigational drugs; chemotherapy, immunotherapy, or radiotherapy or participation in another clinical study with anti-cancer therapy within the past 4 weeks before start of therapy or concomitantly with this study.
14. Treatment with an EGFR- or HER2 inhibiting drug within the past four weeks before start of therapy or concomitantly with this study (2 weeks for trastuzumab).
15. Patients unable to comply with the protocol.
16. Active alcohol or drug abuse.
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Locally advanced or metastatic non-small cell lung cancer
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy over \>/=12 weeks
* Adequate hematological, liver, or kidney function

Exclusion Criteria:

* Previous therapy against epidermal growth factor receptor for metastatic disease
* Treatment with investigational drug during the 3 weeks before enrollment
* History of neoplasm
* Patients with symptomatic cerebral metastases
* Unstable systemic disease
Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver

This project investigates the feasibility of assessing the relative blood volume of carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an interventional platform.

This project will enroll patients with non-diffuse liver disease who are candidates for chemo or radioembolization to treat or manage the disease during an image guided intervention. Subjects will undergo a CT perfusion study of the liver prior to the radioembolizaiton mapping procedure or prior to the chemoembolization treatment. During the radioembolization mapping or chemoembolization procedure, 2 DynaCT acquisitions on the interventional C-arm will be acquired (the second during an injection of an iodinated contrast material) and will be processed using Siemens' PBV software to generate blood volume maps. The diagnostic accuracy of the two approaches to assess the vascularity of the tumors will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* HCC or metastatic liver disease
* Candidate for radioembolization or chemoembolization

Exclusion Criteria:

* Pregnant
* Iodine allergy