cyrilzakka/clinical-trials huggingface dataset:
Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed adenocarcinoma of the pancreas
* resectable disease
* tumor \</= 6cm diameter
* ECOG performance 0-1
* Organ system fxn: granulocytes (\>/=1800/uL); plt ct \>/=100K; bili\</=2mg; liver enzymes \<2.5ULN; crt \</=1.5;
* Normal CXR
* Negative pregnancy test

Exclusion Criteria:

* metastatic disease or peritoneal seeding based on cross-sectional imaging
* previous irradiation to the planned field
* prior chemotherapy or immunotherapy
* active infection
* active PUD
Ketamine Infusion for Comorbid PTSD and Chronic Pain

The purpose of the study is to investigate the effectiveness of low dose IV ketamine infusion in the treatment of patients with PTSD and comorbid chronic pain.

Hypothesis: A single ketamine infusion should be associated with significantly greater reduction in core PTSD symptom levels after the treatment and such an effect is not only due to its analgesic properties but also through unknown mechanism of action that maybe related to NMDA/AMPA receptor modulation.

To date, treatment options (i.e. psychotherapy, antidepressant medications) for patients with PTSD, are relatively few, and considering their limited efficacy, novel therapies have gained interest among researchers and treatment providers alike. Among patients with chronic pain about one third suffer from comorbid PTSD, which further complicates their already challenging pharmacological regimens. Low dose ketamine infusion has shown promise in PTSD, and in treatment of chronic pain, however they have not been studied in comorbid population and under rigorous control conditions. The investigators compared the effects of a single dose of either ketamine (0.5 mg/kg) or ketorolac (15 mg) over a 40-minute of IV infusion in chronic pain patients with and without PTSD, in double blind, randomized study. Measures were collected before, during, 1 day and 7 days after the infusion.

Eligibility Criteria:
Inclusion Criteria:

Veterans with chronic pain as defined by having any chronic pain beyond 6 months in duration with and without PTSD diagnoses (participants must meet DSM-V criteria for current post-traumatic stress disorder (PTSD) and have received a diagnosis of PTSD greater than or equal to 3 months prior to assessment); they also will be either free of concomitant use of psychotropic and/or pain medications for at least 6 weeks or on stable doses of those medications within the last 6 weeks prior to randomization and for the duration of the study; if applicable, current frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study.

Exclusion Criteria:

Inability to speak English, inability or unwillingness to provide written informed consent; moderate-to-severe cognitive impairment (Mini-Mental State Examination scores\<20 administered by a trained clinician); current or lifetime history of psychotic or bipolar disorder; current bulimia or anorexia nervosa, alcohol abuse or dependence in the previous 3 months; serious unstable medical illness or sleep apnea; HTN, prolonged QT interval, peptic ulcer disease or recent history of GI-bleed, renal insufficiency, active substance use disorder, active suicidal or homicidal ideation on presentation; pregnancy (confirmed by baseline lab test), the initiation of female hormonal treatments within 3 months of screening, or inability or unwillingness to use a medically accepted contraceptive method for the duration of the study.
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.

PRIMARY OBJECTIVES:

I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).

II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).

SECONDARY OBJECTIVES:

I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.

II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.

III. To assess patient reported outcomes (PROs).

EXPLORATORY OBJECTIVES:

I. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:

* modified barium swallow (MBS) study kinematics;
* MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
* MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
* Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
* Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES).

OUTLINE:

Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).

Eligibility Criteria:
Inclusion Criteria:

1. Age \<=18 years.
2. Individuals without a laryngopharyngeal disorder (health controls) or with a laryngopharyngeal disorder. Laryngopharyngeal disorder includes but is not limited to: presbylarynx, aspiration; spasmodic dysphonia; globus pharynges; vocal fold paralysis; iatrogenic injury to the larynx; muscle tension dysphonia; neurogenic dysphagia; laryngeal sensory neuropathy; and laryngopharyngeal disorders resulting from prior radiation therapy in individuals with a history of head and neck cancer who have completed radiation therapy as primary or adjuvant cancer treatment
3. Ability and willingness to comply with study procedures.
4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Non-English speaking.
2. Laryngopharyngeal structures are not accessible on exam.
3. Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy.
4. Vocal fold immobility or severe hypomobility on adduction.
5. For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed).
Predicting Cognitive Resilience Against Sleep Loss

Resilience is the ability to cope effectively and adapt to a wide range of stressful environmental challenges. Sleep loss has been shown to reduce activity in the brain regions responsible for resilience. The ability to resist the effects of sleep loss appears to be a stable, trait-like quality. This study will attempt to predict individuals' trait-resistance to sleep loss based on their neurobiology.

Resilience, the ability to cope effectively and adapt to a wide range of stressful environmental challenges, appears to be mediated extensively by the medial prefrontal cortex (MPFC). Sleep deprivation has been shown to reduce metabolic activity throughout the brain, particularly the MPFC. The ability to resist the effects of sleep loss appears to be a stable, trait-like phenomenon that is consistent across situations, suggesting that it may reflect an enduring quality of the underlying neurobiological system. The present study aims to identify the neural basis of resilience and effectively discriminate resistant from vulnerable individuals during an overnight sleep deprivation session. Specifically, the primary aims of this research are 1) to further our understanding of the role of the MPFC in resilience and 2) to develop a statistical prediction algorithm based on multimodal neuroimaging that will reliably discriminate between individuals who are resilient versus vulnerable to the cognitive impairing effects of sleep loss.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-45 years
* Right handedness as assessed by the Edinburgh Handedness Inventory
* For women: regular menstrual cycles (duration between 25 and 35 days with no more than 3 day variation between cycle)

Exclusion Criteria:

* History of head injury with loss of consciousness or post-traumatic amnesia, or major neurological illness
* Medical or neurologic condition that would confound interpretation of results, including alcohol or drug abuse/dependence in the past 6 months, neurological disorders including any history of seizures
* History of cardiac problems
* History of major depressive disorder or anxiety disorder
* Lifetime history of psychotic disorder, including bipolar disorder, schizophrenia, or obsessive compulsive disorder
* Other DSM-IV diagnosis that could affect interpretation of results
* Mixed or left handedness
* Abnormal visual acuity that cannot be corrected by contact lenses
* Daily caffeine use exceeding 400 mg per day
* History of smoking or tobacco use in the past year
* Metal within the body, pregnancy, or other contraindication for MRI procedures
* Use of drugs or medications that could affect functional neuroimaging results (e.g., fluoxetine, beta-blockers)
* Psychotropic medication use within the past 6 weeks
Study of Opioid Use After Lumbar and Cervical Spine Surgery

The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.

After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-report questionnaires related to medical history, social demographic, and psychosocial variables that are related to low back pain, and often used in clinics that manage patients with low back pain. They will then be randomized to either receive the education, or only usual care (which is the typical information the surgeon provides the patient verbally during the pre-operative appointment). All patients will receive the usual care education from their surgeon.

Education Group:

The educational video is a white board style patient-centric video. The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer on-acute pain. It also discusses some of the dangers of long-term opioid usage.

All Subjects:

All subjects will receive the usual care education that is typically given by their surgeon. That will be left up to the discretion of each surgeon.

All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted, and then again at 6 months to ask history of prescription opioid utilization.

Eligibility Criteria:
Inclusion Criteria:

1. Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery.
2. Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
3. Between the age of 18 - 65 years
4. Read and speak English well enough to understand the education, provide informed consent and follow study instructions

Exclusion Criteria:

a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication
Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years

Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.

Embryos from in vitro fertilization are routinely transferred into the woman's uterus at cleavage stage (Day 2 to 3) or at blastocyst stage (Day 5 to 6).

The rational of blastocyst stage transfer is that blastocyst stage is the most biologically correct stage for embryos to be in the uterus, and longer culture in the laboratory may give the possibility to reduce the number of genetically abnormal embryos.

The investigators design a single center randomized trial, including 388 women aged less than 39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers (ETs) and cleavage stage ETs. Each patient is randomized with a non blind randomization, based on a computer model, on the first day after fertilization.

The primary outcomes are implantation and pregnancy rate. The secondary outcome is to verify if blastocyst embryo transfer leads to a higher multiple-pregnancy rate.

An interim analysis takes place at one third of the population. Follow up is of 4 weeks for implantation rate, and covers 8 weeks regarding pregnancy rate.

Eligibility Criteria:
Inclusion Criteria:

* female patients undergoing IVF procedures
* age less than 39 years

Exclusion Criteria:

* less than 4 fertilized eggs in day 1 after IVF
Impact of Exercise Training on Frailty in CVD Patients.

The aim of this research project is to examine the impact of aerobic exercise on markers of frailty in patients (of 65 years or older) suffering from heart failure (HF) or after coronary artery bypass grafting (CABG) or mini aortic valve replacement procedures (mini-AVR).

Frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. Based on previous research, there are indications that frailty is highly prevalent in HF, CABG and mini-AVR patients. As a consequence, these patients (both men and women of 65 years or older) will be included in this research project. The 12-week aerobic exercise program (3 sessions per week) will consist of ergometer, treadmill and arm-ergometer exercises. The intensity will be based on the maximal cardiopulmonary exercise test (CPET) of the patient and will correspond with a heart rate between the first and second ventilatory threshold (with a gradual progression over time).

Secondary, correlations will be examined between markers of the CPET and frailty markers.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of at least 65 years of age at the start of the study
* To be admitted to Jessa Hospital Hasselt for cardiac rehabilitation after CABG or mini-AVR surgery or because of HF
* Diagnosed as being frail based on the Phenotype of Fried.

Exclusion Criteria:

* A persistently unstable clinical condition (e.g. angina, advanced conduction disturbances, threatening ventricular arrhythmias or acute HF)
Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

Acetazolamide improves central sleep apnea related to opium consumption.

This is a double-blind, placebo-controlled, cross-over designed study to evaluate the effect of acetazolamide on central apneas in opium-user patients.

We are going to invite 12 eligible patients to enter our study. this sample will be obtained from the referral patients to Masih Daneshvari hospital sleep Lab. Eligible patients will undergo a full night polysomnography (PSG) to have a new measure of apnea indexes as baseline. Epwoth Sleepiness Scale Questionnaire (ESS) will be filled by the patient the night of the study.also an arterial blood sample will be obtained at the morning of each study. if the patient have more than 5 central apneas in each hour he/she will be scheduled to randomly receive a box containing 6 capsules to use one hour before bedtime at coming nights. The prescriber physician who will also score the tests and the patients are unaware either these capsules are acetazolamide 250mg or placebo. at 6th night we will perform PSG together with ESS questionnaire and arterial blood gas (ABG). after 2 weeks washout the patient receive another box containing 6 capsules with similar appearance to previous ones. If the patient receives acetazolamide in the first six nights, he/she will receive placebo in the second phase of the study and if the patient receives placebo in the first phase, he/she will receive acetazolamide in the second phase.

after the second 6 days, the third PSG will be performed plus ESS measurement and morning ABG sampling. Coded polysomnograms will be scored blindly.

Eligibility Criteria:
Inclusion Criteria:

* Opium or opioid use for at least two months in a daily manner
* Presence of five or more central sleep apnea per hour in a full-night recorded PSG

Exclusion Criteria:

* Congestive heart failure
* living in high altitude
* Chronic Obstructive Pulmonary Disease (COPD)
* Carbon dioxide partial pressure (pCO2) elevation due to other respiratory diseases
* Body Mass Index (BMI) \> 32
* Obesity Hypoventilation Syndrome
* Severe renal or liver disorders
* Using Benzodiazepine
* Using Theophylline
Study of Information Received About Fertility and Infertility in Patients Who Have Finished Treatment for Cancer

RATIONALE: Learning about the amount of information on fertility and infertility by patients before they received treatment for cancer in a comprehensive cancer center may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying the amount of information on fertility and infertility received by patients before treatment of cancer in patients who have finished treatment.

OBJECTIVES:

Primary

* To determine the amount of information received on aspects of fertility and infertility in patients with cancer prior to receiving treatment in a comprehensive cancer center.

Secondary

* To analyze whether the information received by patients is related to the desire to be parents.
* To analyze whether the information received by patients is related to the desire to be informed.
* To determine whether there is a relationship between demographic data, diagnosis, quality of life, and associated psychosocial information received by patients.

OUTLINE: Patients complete questionnaires (Lickert and QLQ-C30) on the amount of information received prior to therapy and psychosocial issues on aspects of fertility and infertility once within 1-2 years after receiving treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer, germ cell tumor, colon cancer, leukemia, lymphoma, or sarcoma

  * Free of disease
* Completed treatment within the past 1-2 years

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Must be able to read and self-complete study questionnaires
* No psychological conditions that may prevent participation in the study

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent treatment (hormonal treatment for breast cancer is allowed)
Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C

This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically verified operable rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0
* Age: 18-80 years
* Karnofsky Performance Status \> 80
* Adequate bone marrow reserve (leukocytes \> 4,000, thrombocytes \> 105/mm3, Hb \> 10g %), renal and hepatic functions (total bilirubin and creatinine \< 1.25 x ULN)

Exclusion Criteria:

* Colon cancer
* R1, R2; carcinosis peritonei
* Start of treatment \> 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
* Previous application of a murine or chimeric monoclonal antibody or antibody fragment
* Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study
* Known hypersensitivity to animal protein
* Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell. gravis, cerebral seizure disorder, et al.
* Pregnancy or lactation
Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma.

108 patients were randomized to receive no induction chemotherapy (IC, Arm A) or IC (Arm B) before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma. Patients assigned to Arm B first received two cycles of 3-weekly schedule of IC, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the esophagus;
2. Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and CT scan (according to UICC TNM version 6);
3. Absence of distant metastasis of solid organ;
4. Not suitable for surgery (either for medical reasons or patient's choice);
5. Age at diagnosis 18 to 70 years;
6. Eastern Cooperative Oncology Group performance status ≤ 2
7. No prior cancer therapy;
8. No history of concomitant or previous malignancy;
9. Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;
10. Renal function: Cr ≤ 1.25×UNL;
11. Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;
12. Documented informed consent to participate in the trial.

Exclusion Criteria:

1. Younger than 18 or older than 70 years of age;
2. ECOG performance status of 3 or above;
3. Other cancer history;
4. Previous radiotherapy history;
5. Subjects with distant metastases;
6. Pregnancy or breast feeding. Women of childbearing age must use effective contraception;
7. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);
8. Evidence of bleeding diathesis or serious infection.