cyrilzakka/clinical-trials huggingface dataset:
Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

Head and neck cancer is a general description of a disease that includes several types of soft tissue carcinomas that develop in the head and neck regions.

Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion molecule (Ep-CAM) that is highly expressed on squamous cell carcinomas of the head and neck (SCCHN). Proxinium is administered via intratumoural injection.

The primary objective of the study is to compare the overall survival time for patients treated with intratumourally injected Proxinium plus BSC versus BSC alone. Secondary objectives of the study include comparison of locoregional tumour control, local progression-free survival, symptomatic benefit and safety profile in patients who receive Proxinium plus BSC versus patients who receive BSC

Eligibility Criteria:
Inclusion Criteria:

Disease Characteristics

* The patient must be 18 years of age or older.
* The patient must have squamous cell carcinoma of the head and neck.
* The squamous cell carcinoma must be Ep-CAM positive.
* ECOG performance status of 0, 1, 2 or 3.
* 12 week life expectancy

Prior/Concurrent Therapy

* The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).
* The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour.
* The patient's disease must be refractory.
* There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug.

Patient Characteristics

* The patient must have adequate hepatic function \[alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN\].
* The patient must have adequate renal function (serum creatinine \< 1.5 × ULN).
* The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin \>8 g/dL.
* The patient must have prothrombin time and partial thromboplastin time within normal limits.

Other

• Women of childbearing potential and male patients must agree to use a highly effective contraceptive method.

Exclusion Criteria:

* The patient has clinically significant distant metastases.
* The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy.
* The patient has a nasopharyngeal tumour.
* The patient has AIDS, hepatitis C or hepatitis B.
* The patient has clinically significant renal or hepatic disease.
* Tumors are prone to bleeding.
* The patient is pregnant or lactating.
* The patient requires 'blood thinning' medications and can not safely discontinue the medication.
* The patient is currently enrolled in another clinical trial.
Evaluation of Mailers Promoting Mammogram Screening

In this evaluation, 3 different versions of mailers promoting annual mammograms are being sent to women on the month of their 50th and 64th birthdays. The researchers hypothesize that the use of behavioral nudges in the mailers should lead to increased uptake in mammogram screening.

Mammogram screening for women, starting at age 50, can significantly reduce the risk of complications due to breast cancer. As part of an existing outreach campaign, the health system mails a postcard and small gift (pink socks) to women on the month of their 50th and 64th birthdays to promote annual mammogram screening.

The researchers are evaluating two new versions of the mailers against a standard mailer to see which version leads to greater uptake in mammograms. The new mailers have content that applies behavioral nudge theory - specifically, loss frames and fear appeals - to encourage taking action. One of the two new versions does not include the small gift, to test whether its inclusion or exclusion has any effect on mammogram screening.

Eligibility Criteria:
Inclusion Criteria:

* Female Geisinger Health Plan members turning 50 and 64 in that month
* For the 2020 campaign, birthdays from June 2020 (as opposed to August 2020) will be included due to a temporary suspension of the outreach program due to the COVID-19 pandemic since June
* For the pre-post examination of the 2019 campaign, all months in that year will be included

Exclusion Criteria:

- Members who are on the do not contact list at Geisinger Health Plan
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Measurable Disease
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Lab / imaging requirements
* Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C
* Men and Women \> 18 years (16 were allowable)
* Prior therapy restriction (adjuvant only)

Exclusion:

* Pregnant / nursing
* Inadequate contraception
* Brain metastasis
* Primary ocular or mucosal melanoma
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC

The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day \[primary outcome\], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control \[WLC\]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age

  * Report daily cigarette smoking (\>=10 cigarettes per day in the past week)
  * Not ready to quit smoking (not planning to quit in the next 30 days)
  * Willing to try e-cigarettes
  * In stable buprenorphine (BUP) treatment for opioid use disorder at an Massachusetts General Hospital-affiliated primary care clinic (in treatment for \>=3 months without changes in BUP dose in the past 2 weeks and planning to remain on current BUP treatment for \>=3 months).

Exclusion Criteria:

* Pregnant or breastfeeding
* Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (\>3 days in past 30 days)
* Report past 30-day use of behavioral or pharmacologic smoking cessation aids
* Deemed inappropriate for participation by their OUD provider
* Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy \<1 year).
Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT

ASPHALT is an academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. 450 patients with confirmed acute ischemic stroke will be recruited over a 3-year period, with 3-month follow-up.

Instead of the traditional approach of waiting until the patient arrives at the hospital to perform brain imaging and start reperfusion therapies, mobile stroke units (MSUs; ambulances equipped with a CT scanner) now allow pre-hospital initiation of intravenous thrombolysis (IVT). Two large non-randomized clinical trials (B_PROUD \& BEST-MSU) have recently shown that MSU use leads to improved functional outcomes at 3 months in specific settings. However, MSUs have been criticized because of their cost and a lack of evidence of a significant reduction in the time between symptom onset and mechanical thrombectomy, which is the cornerstone of treatment of patients with large vessel occlusion.

We hypothesized that compared to usual care, the deployment of a MSU would result in an incremental cost-utility ratio ≤50,000 euros per QALY in the lifetime horizon, even in an area with many thrombectomy-capable centers..

Academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. Randomization will be performed on an individual patient basis (randomization of MSU deployment at dispatch). 450 patients with confirmed acute ischemic stroke (emergency call ≤6 hours after onset) will be recruited over a 3-year period, with 3-month follow-up. Costs and clinical outcomes will be collected prospectively during the study period and used to extrapolate the incremental cost-utility ratio over a lifetime horizon.

Eligibility Criteria:
Inclusion Criteria:

* Emergency call to one of the two following emergency medical service (EMS) dispatch centers : SAMU (Service d'Aide Médicale Urgente) or BSPP (Brigade des Sapeurs Pompiers de Paris), between 08:00 and 18:00, 5 days a week (Monday to Friday).
* Suspected acute stroke according to a dispatcher stroke identification algorithm, adapted from the ROSIER scale
* Symptom onset-to-randomization time ≤ 6h
* Patient located within the predefined catchment area of the MSU
* MSU available at the time of the EMS call
* Informed consent (as approved by the ethics committee, informed consent will be obtained after randomization: at the arrival of the MSU (intervention group), or at hospital arrival (control group))

Exclusion Criteria:

* Patient confined to be more than 50% of waking hours
* Unknown or uncertain onset time (e.g. wake-up stroke)
* Medical history of epilepsy
* Recent epileptic seizure (\<12 hrs)
* Suspicion of pregnancy
* Parturient or breastfeeding woman
* Patient already participating in another interventional study, which could influence the mRS at 3 months.
* Patient under guardianship or curatorship
* Patient not affiliated to French Social Security
Effects of Kinesiotaping With and Without Pelvic Tilts in Dysmenorrhea

This study aims to determine the effects of kinesiotaping with \& without pelvic tilts on pain \& menstrual distress in females with dysmenorrhea. This study will be a randomized controlled trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea.

This study will be a randomized controlled trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea. Subjects with primary dysmenorrhea meeting the predetermined eligibility criteria will be divided into two groups using the random sequence generation method. Pre-intervention responses shall be taken during the first menstrual cycle using the Numeric Pain Rating Scale, WaLLID tool \& Menstrual Distress Questionnaire.

Subjects in Group A shall be treated with kinesiotaping and pelvic tilts while subjects in Group B shall be treated with kinesiotaping only. Each subject will receive 02 treatment sessions during the second \& third menstrual cycles. Post-intervention responses shall be recorded in the fourth menstrual cycle using the Numeric Pain Rating Scale, WaLLID tool \& Menstrual Distress Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 years
* Nulliparous
* Regular menstrual cycles
* Primary dysmenorrhea (diagnosed via WaLLID tool)

Exclusion Criteria:

* Allergic to kinesiotape
* Skin disorders
* Uterine fibroids
* Endometriosis
* Polycystic Ovarian Syndrome
Long Pressure Autoregulation Index

The pressure reactivity index (PRx) has emerged as a surrogate method for the continuous bedside estimation of global cerebral autoregulation and a significant predictor of unfavorable outcomes. However, calculations require continuous, high-resolution monitoring and are currently limited to specialized ICUs with dedicated software. To overcome this problem, new indices calculated using one-minute average data, instead of 10-second average data as performed by the PRx, have been proposed.

The study aims to test new physiological indices appropriately modified to adapt to the scarcity of output data generated by standard hospital systems (frequency \~0.0033 Hz, approximately a 5-minute period) and to evaluate their association with outcome measures.

Data preparation and index calculations were performed using an in-house algorithm.

Data extracted and processed with the algorithm:

Ultra-low pressure reactivity index (UL-PRx), Intracranial pressure (ICP), Cerebral perfusion pressure (CPP), Arterial blood pressure (ABP), heart rate (HR), respiratory rate (RR), temperature, end-tidal CO2 (EtCO2), saturation (SpO2).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of acute neurological injury requiring intracranial pressure (ICP) monitoring.
* Availability of continuous intensive care monitoring of physiological data.

Exclusion Criteria:

Patients with less than 8 hours of physiological data monitoring.
QTX3034 in Patients With KRAS G12D Mutation

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic
* Part 1: - Advanced solid tumors with at least 1 prior systemic therapy
* Evaluable or Measurable disease per RECIST 1.1.
* Parts 2 and 3: Measurable disease per RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate organ function

Exclusion Criteria:

* Prior treatment with a KRAS inhibitor
* Active brain metastases or carcinomatous meningitis
* History of other malignancy within 2 years
* Significant cardiovascular disease
* Disease or disorder that may pose a risk to patient's safety

Other protocol-defined Inclusion/Exclusion Criteria may apply
Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals

This is a cluster randomized trial to determine whether a package of care including rapid antiretroviral therapy (ART) initiation, as compared to standard ART initiation, improves mortality, retention in care and viral suppression among treatment naive people living with HIV (PLHIV) in Nepal. Package of care includes immediate screening and treatment of opportunistic infections (OIs), rapid ART initiation and enhanced retention in care using mobile health (mHealth) and weekly/biweekly home-based adherence/ retention support linked to community care centre. Standard of care includes screening and management of common OIs, baseline assessment (CD4, viral load and other tests), antiretroviral drugs and ART follow up.

PRAN is an open-label trial of 1000 Treatment-Naive PLHIV aged 16 years or more.

1. To evaluate whether a package of care including rapid ART initiation \[diagnosis and management of opportunistic infection (OI), rapid ART initiation and enhanced adherence support\] is more effective in reducing morbidity and mortality, as compared to standard ART initiation, among ART naïve PLHIV in Nepal.
2. To evaluate whether a package of care including rapid ART initiation is more effective in improving retention in HIV treatment, as compared to standard ART initiation, among ART naïve PLHIV in Nepal.
3. To evaluate whether a package of care including rapid ART initiation improves viral suppression among ART naïve PLHIV in Nepal to a higher extent than standard ART initiation,
4. To evaluate whether the different components of care act synergistically to improve mortality, retention in care and viral suppression among treatment Naive PLHIV, as compared to standard ART initiation,
5. To assess the cost-effectiveness of this package of care intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 16 years
* Diagnosed with HIV-infection
* ART-naive
* Consent for study participation

Exclusion Criteria:

* Age less than or equal to 15 years
* Any previous use of ART
A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy

The purpose of the study is to evaluate the effect of ALN-APP on measures of CAA disease progression and to characterize the safety, tolerability, and pharmacodynamics (PD) of ALN-APP in adult patients with sporadic CAA (sCAA) and Dutch-type CAA (D-CAA). The study will be conducted over 2 periods: a 24-month double-blind treatment period and an optional 18-month open-label extension (OLE) period. The estimated duration of study participation, inclusive of screening, treatment, and additional safety follow-up, is up to 50 months.


Eligibility Criteria:
Inclusion Criteria (sporadic CAA patients):

* Is 50 years or older
* Has probable CAA per the Boston Criteria Version 2.0

Inclusion Criteria (Dutch-type CAA patients):

* Is 30 years or older
* Has known E693Q amyloid precursor protein (APP) gene mutation for Dutch-type CAA

Exclusion Criteria:

* Moderate or severe stage Alzheimer's disease (AD) or significant cognitive impairment (CI)
* Has a history of previous clinical intracerebral hemorrhage (ICH) with onset less than 90 days prior to anticipated randomization in the study
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN) at Screening
* Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 at Screening
* Has recently received an investigational agent
* Has had treatment with amyloid-targeting antibody

Note: other protocol defined inclusion / exclusion criteria apply
Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation

1. OBJECTIVES:

   General objective: Assess the effects of a music therapy intervention during the weaning from the mechanical ventilation in a group of patients, and compare it to the usual clinical practice.

   Specific objectives: Main objective: assess the effect of a music therapy intervention on the length of the weaning in a group of critical patients, and compare it to a group of critical patients who receive the usual clinical practice.

   Secondary objectives:
   * Compare the levels of sedo-analgesia required in critical patients receiving the music therapy intervention during the process of weaning versus the levels of sedo-analgesia required by the control group.
   * Compare the Anxiety-agitation level in critical patients receiving the music therapy intervention during the process of weaning, versus the anxiety-agitation leved felt by the control group.
   * Compare the level of pain in critical patients receiving the music therapy intervention during the weaning versus the level of the pain felt by the control group.
   * Compare the level of delirium in critical patients receiving music therapy during the weaning versus the level of delirium of the control group.
   * Compare heart and breath frequency, blood pressure and oxygen saturation in critical patients receiving music therapy during the mechanical ventilation extubation (weaning) process, versus the index of control group.
   * Compare the stress perceived in critical patients receiving music therapy intervention during the mechanical extubation process, versus the level of the control group, which receives the usual medical care (without intervention with music therapy), 90 days after Inico of the process, Perceived the Stress Scale (PSS).
   * Describe and analyze the experience by the patient of the intervention with music therapy the weaning process and the coping strategies possible for musicotherapeutic intervention, using a Semi-instructed interview that takes place at 90 days beginning the process.
2. DESIGN: single blind clinical trial in parallel groups, single blind clinical trial.
3. POPULATION of this study are patients who initiate weaning for ventilation mechanics.

Experimental group: Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation.

Control group: Patient will follow the usual clinical practice for the weaning from mecanichal ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation for at least 48 hours, with the decision to start the process of weaning, which comes determined by the decision to switch from controlled mode to support or spontaneous breathing modalities.

Exclusion Criteria:

* Patients with established moderate-severe psychiatric pathology.
* Patients with severe hearing deficit.
* Patients in whom the Limitation of Life Support Treatment (LTSV) has been decided and have a life expectancy of less than 48h.
Tips for Infant and Parent Sleep (TIPS)

A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later.

Infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the infant, development of the infant's sleep physiology, maternal sleep habits and behaviors, and maternal feelings related to her sleep and her baby's sleep. These factors may be modifiable through the use of behavioral-educational interventions. A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later. Sleep-wake patterns will be analyzed through the use of actigraphy, a wristwatch-like device that measures sleep-wake activity. This is a pilot study which will test the usefulness and practicality of this type of program, so that a larger scale study can be developed.

Eligibility Criteria:
Inclusion Criteria:

* Singleton baby born at GA \>37 weeks
* baby 8 hours to 7 days old
* Mother age 16-50 years
* Normal, healthy infant as described in newborn examination
* First time parents living in the Greater Toronto Area
* Mother planning to provide fulltime care to her infant for at least the first six weeks after discharge home

Exclusion Criteria:

* Maternal or infant complications requiring prolonged hospital stay
* Previous stillbirth or neonatal death
* Maternal chronic illness
* Maternal use of medications that affect sleep (e.g. benzodiazepines, any sleep aid)
* Known drug or alcohol use beyond occasional social use
* Smoking two packs a day or more
* Either parent has a diagnosed sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
* Mother's partner is working night shifts
* Mother unable to read or understand English
* No telephone in the home
* Involvement in another research protocol involving sleep