cyrilzakka/clinical-trials huggingface dataset:
Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery

RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer.

PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.

OBJECTIVES:

* Compare the disease-free survival of patients with stage III colon cancer treated with S-1 or tegafur-uracil and leucovorin after curative surgery .

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days 1-21. The treatment repeats 5 times every 5 weeks.
* Arm II: Patients receive oral S-1 twice daily on days 1-28. The treatment repeats 4 times every 6 weeks.

Biological samples are collected for gene expression analysis for identification of predictive markers.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of colon

  * Stage III (T1-4, N1-3, M0) disease
* Has undergone surgical resection of the tumor within the past 8 weeks

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Able to take medications orally
* WBC ≥ 3,500/mm³ and \< 12,000/mm³
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Total bilirubin ≤ 2.0 mg/dL
* AST/ALT ≤ 100 IU/L
* Creatinine ≤ 1.2 mg/dL
* No other active malignancies
* Must have none of the following comorbidities:

  * Severe postoperative complications
  * Uncontrollable diabetes mellitus
  * Uncontrollable hypertension
  * Myocardial infraction within 6 months
  * Unstable angina pectoris
  * Hepatocirrhosis
  * Interstitial pneumonia, pulmonary fibrosis, or severe emphysema

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy for colon cancer
* No concurrent radiotherapy
* No concurrent biological response modifiers
Short Term Group Therapy for OCD

Assessing OCD before and after group therapy


Eligibility Criteria:
Inclusion Criteria:

* OCD
* Eligibility to participate in group therapy

Exclusion Criteria:

* PTSD
* Suicidal thoughts
* Psychotic state
* Severe hostile personality disorder
An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers

The 2-year research plan will test the Extended Put It Out Project (POP-6) in a pilot randomized trial (N=168) compared to TSP-6, as well as comparing POP-6 and TSP-6 to the POP-3 and TSP-3 interventions from a previously-conducted trial. Participants will be young adults who smoke, identify as sexual or gender minorities (SGM), and use Facebook. Primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence at 3 and 6 months.

Participants will be randomized to one of two conditions: (1) a 6-month Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 6-month Facebook intervention targeting tobacco use. Both interventions will include 180 days of Facebook-based messages and activities tailored to participants' readiness to quit smoking.

Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva nicotine test kits that will be mailed to participants.

Eligibility Criteria:
Inclusion Criteria:

* read English
* between 18 and 25 years of age
* indicate they use Facebook "most" (≥ 4) days per week
* have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
* identifies as SGM
* lives in California

Exclusion Criteria:

* do not read English
* are not between 18 and 25 years of age
* indicate they do not use Facebook "most" (≥ 4) days per week
* have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
* does not identify as SGM
* does not live in California
Impact of Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma

Multiple myeloma is the second most frequent hematologic malignancy, which incidence augmented between 1995 and 2018, with an annual mean variation of +0.6% to 1.1%. Although treatment improved in the last years, the patients' prognostic is associated with cytogenetic abnormalities.

Oncological supportive care provides patients with a global perspective, in addition to specific medical treatment adapted to pathology and patient profile. It contributes to the improvement of quality of life of patients, throughout their care pathway regarding physical, psychological and social aspects, according to their specific needs as well as their caregivers'.

The aim of this study is to evaluate the quality of life at 6 months after multiple myeloma diagnosis in outpatients receiving paramedical consultations in oncological supportive care from the diagnosis versus outpatients receiving paramedical consultations in oncological supportive care after 6 months after diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Age superior to 18 years old
* Patient recently diagnosed with multiple myeloma not eligible to autologous blood stem-cell transplantation, before starting therapy in day hospital
* Patient coming regularly to Centre Henri Becquerel for treatment and follow up for multiple myeloma
* Informed consent form signed

Exclusion Criteria:

* Inclusion Criteria:
* Age superior to 18 years old
* Patient recently diagnosed with multiple myeloma not eligible to autologous blood stem-cell transplantation, before starting therapy in day hospital
* Patient coming regularly to Centre Henri Becquerel for treatment and follow up for multiple myeloma
* Informed consent form signed

Exclusion Criteria:

* Patient with urgent need of treatment after multiple myeloma diagnosis with urgent and absolute need of oncological supportive care immediately after diagnosis
* Patient deprived of liberty, under judicial supervision, under guardianship or trusteeship
* History of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation
Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Post Dural Puncture Headache

Postdural puncture headache (PDPH) is a common complication associated with neuraxial anesthesia and diagnostic lumbar puncture (LP). PDPH is defined as a bilateral headache that develops within 7 days and disappears within 14 days after the dural puncture with a distinct postural quality. PDPH causes significant short-term disability, prevents ambulation and care of the newborn (in obstetrics), and results in a prolonged hospital stay.

The sphenopalatine ganglion (SPG) is an extra-cranial neural structure located in the pterygopalatine fossa that has both sympathetic and parasympathetic components as well as somatic sensory roots. The trans-nasal approach is a low risk, noninvasive technique that is easily performed and could potentially be beneficial in the treatment of PDPH through blocking the parasympathetic ﬂow to the cerebral vasculature through the sphenopalatine ganglion which will allow the cerebral vessels to return to normal diameter and thus relieve the headache.

The greater occipital nerve contains sensory fibers from C2 and C3 segments of medulla spinals. It arises from the dorsal ramus of C2 segment, contains a thin branch from C3 segment, and innerves the medial aspect of posterior scalp up to the anterior aspect of vertex. Greater occipital nerve block (GONB) inhibits the pain sensation of this region.

There is some evidence to suggest the effectiveness of GONB in the management of PDPH. Nowadays, guidelines for the management of PDPH were modified and included GONB as a part of standard management of PDPH.

* Dexamethasone possess potent antiinflammatory and immunosuppressive actions by inhibiting cytokine-mediated pathways.
* Many providers believe that the local anesthetic produces the rapid onset of headache relief, like an abortive agent, and that the locally acting steroid produces the preventive like action of up to 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

ASA I-II Patients undergoing elective cesarean section requiring spinal anesthesia, who developed PDPH during hospitalization or within days of the intrathecal block.

Exclusion Criteria:

* Patient refusal.
* Any contraindication to regional block (coagulopathy or anticoagulant therapy).
* Local scalp infection.
* Nasal polyp, trauma, septal deviation or any nasal pathology.
* Allergy to local anesthetics.
* Pregnancy induced hypertension.
* History of major psychiatric disorders.
* Chronic headache.
* Substance abuse.
* Current opioid use.
Decrease Trauma-related Shame with Virtual Reality: the Effectiveness of SHINE-VR

Suffering from PTSD in childhood can have detrimental formative consequences. Researchers have been eager to develop effective interventions and to enhance treatment motivation since the introduction of the diagnosis of PTSD in the DSM. With evolving understanding of the disorder, its definition and criteria have changed over the course of time. The most recent change involves the addition of the criterium D of negative affects or emotions in relation to PTSD, the feeling of shame amongst others. Individuals experiencing interpersonal trauma, such as sexual abuse, are at high-risk developing trauma-related shame, which in turn can impact the course and effectiveness of PTSD treatment. Shame-inducing situations are typically being avoided, and the feelings are not disclosed to peers and other people. Hence, acknowledging and sharing feelings of shame as well as practicing self-compassion have been proposed to reduce the impact of that negative self-conscious emotion. These aspects get partially tackled in evidence-based trauma therapies, however, there appears to be a need for a more specific trauma-related shame intervention in addition to existing treatments. Recent research has focused on developing such interventions for adults and has reported positive effects.

To our knowledge, there is no intervention specifically tackling trauma-related shame in adolescents. Virtual Reality (VR) is a promising tool for such an intervention. Findings suggest that including VR in a treatment results in high treatment satisfaction and that it is highly motivating for its users, which is a crucial component for treatment success.

The goal of this study is to test the effectiveness of a short-term VR shame intervention (SHINE-VR) for adolescents suffering from PTSD after having experienced sexual abuse. The primary objectives of this study to assess the effect of SHINE-VR on trauma-related shame, self-compassion, and PTSD symptom reduction, to investigate whether treatment motivation, an increase in self-compassion, and a decrease in trauma-related shame are associated with PTSD symptom reduction, and the evaluation of SHINE-VR by assessing the feasibility of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Between 12 and 17 years old at inclusion
* Interpersonal trauma (sexual abuse); in case of multiple traumas the main trauma should be sexual abuse
* Indication for PTSD treatment
* Getting trauma treatment as usual
* Adequate command of the Dutch language

Exclusion Criteria:

* Known mental disability
* Epilepsy
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

1. Planned registration period 3 years
2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL


Eligibility Criteria:
Inclusion Criteria:

- Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Exclusion Criteria:

* N/A
Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (\< 36.5 degrees C) without increasing hyperthermia (\> 37.5 degrees C).

Prevention

After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
* Delivery in the hospital.

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele.
* Major congenital anomaly.
* Blistering skin disorder.
Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection

This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.

COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, has led to an unprecedented global pandemic affecting persons of all ages. Pregnant women are in a physiologic immunosuppressed situation and have a greater risk and severity of respiratory infection. However, considerable uncertainty exists regarding the potential for vertical transmission (prenatal/congenital or perinatal) of SARS-CoV-2 from infected pregnant women to their newborns and its potential clinical consequences.

This study attempts to provide evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; trasnplacental and human milk antibody transfer and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women hospitalized presenting with:

  1. Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty)
  2. Diagnoses of pneumonia with no other explainable cause.

Exclusion Criteria:

* None
Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis

Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate.

Ten male and female patients diagnosed with Peripheral artery disease (PAD), will be recruited. This diagnosis will be based on medical history, physical examinations, laboratory tests, and specific diagnostic tests. Patients qualified for this study, are patients with distal extremity ischemia indicated by claudication and rest pain present for a minimum of 4 weeks without evidence of improvement in response to conventional drug therapy; showed angiographic evidence of PAD in the affected limb; and were not candidates for surgical revascularization. Platelet lysate will be injected intramuscularly at different sites of the gastrocnemius muscle. The purpose of this study is to evaluate the safety and efficacy of platelet lysate injections into ischematic limbs of patients with PAD.

Eligibility Criteria:
Inclusion Criteria:

* Competent and willing to give informed consent, and to be available for all baseline treatment and follow up examinations required by the protocol.
* Gender: Male or female.
* Established Peripheral arterial disease, clinically and hemodynamically confirmed as per Rutherford 3, 4 and
* History of intermittent claudication for \> eight weeks.
* Limited exercise due to moderate to severe claudication.
* Resting ankle brachial index (ABI) \< 0.85, toe pressure ≤ 60 mm Hg, Toe brachial index (TBI) \<0.6, or Trans-cutaneous oxygen pressure (TcPO2) ≤ 60 mmHg in the foot.
* Not eligible for surgical or radiological revascularization.
* In case of diabetic patients, he/she should be on medication and fairly controlled (HbA1c \<10%).
* Normal liver enzymes, serum creatinine \< 1.4
* Normal platelet count.
* On regular medication for hypertension if any.
* No evidence of malignancy
* Low Questionnaire scores.
* Body mass index \<30.

Exclusion Criteria:

* Women with child bearing potential, pregnant and lactating women.
* Rheumatoid Arthritis.
* History of neoplasm or malignancy in the past 10 years.
* Reported unstable cardiovascular disease, heart failure or symptomatic postural hypotension within 6 months before screening.
* Leg edema
* Inflammatory or progressive fibrotic disorder
* Renal insufficiency or failure
* History of infectious disorder.
* Chronic inflammatory disease
* History of stroke or myocardial infarction ( \< 3 months).
* Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).
* Lab values for
* Hemoglobin \<10 g/dl.
* Platelet count \<100,000.
* Prothrombin time/ partial thromboplastin time (PT/PTT)\> 3 seconds.
* Alanine aminotrasferase (ALT) and aspartatet aminotrasferase (AST) \> 1.5x of the normal lab value.
* Creatinine ≥ 1.4
* Poorly controlled diabetes (HbA1c ≥10)
* Bilirubin \> 1.5x of the normal lab value.
* Systemic autoimmune disease.
* Receiving immunosuppressant medications.
* Uncontrolled hypertension or hypotension.
* Abdominal aortic aneurism \> 5 cm.
* Active or untreated Tuberculosis.
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion

Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and functional improvement. However, pseudarthrosis and failure to relieve low back pain are unfortunately still frequent, irrespective of the type of procedures and grafts used by the surgeon.

The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
* Symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (L1-S1)
* Unresponsive to non-operative treatment for at least 6 months

Exclusion Criteria:

* Lumbar disc disease requiring treatment at more than one level
* Previous failed fusion at the involved lumbar level
* Local active or latent infection at the involved lumbar level
* Positive serology for hepatitis B, hepatitis C, HIV
* Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator
A Phase II Study of Spinal Radiosurgery

Phase I of the study (motion and quality assurance \[QA\] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.

Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study.

Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area:

Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = \<50% CTV dose/No previous RT = \<80% CTV dose.

Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy.

# Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery.

\*Previous RT:

* greater than six months since completion of RT
* at least 20 Gy, but no more than 50 Gy

Eligibility Criteria:
Inclusion Criteria:

1. All subjects must have history of histologically confirmed neoplasm or radiographically-diagnosed AVM. Patients without a prior tissue diagnosis but who have a radiographically characteristic lesion are eligible if there is consensus agreement of the diagnosis in the UAB Neuro-oncology Tumor Board.
2. ECOG performance status of less than or equal to 2
3. Age greater than 18
4. Life expectancy greater than 12 weeks
5. Subjects given written informed consent

Exclusion Criteria:

1. Cytotoxic chemotherapy within 7 days of treatment
2. Insufficient recovery from all active toxicities of prior therapies
3. Epidural spinal cord compression requiring immediate neurosurgical decompression. If a patient requires immediate surgery for neurologic compromise, they may still be eligible post operatively if tumor was incompletely resected.
4. Patient is non-ambulatory. Optimization of pretreatment neurologic function with steroids is allowed. Ambulation with assistance of walker or cane is allowed.
5. Patient is pregnant and it is judged by the treating Radiation Oncologist that spinal radiosurgery would place the fetus in unacceptable danger.