cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin

Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung
* No prior systemic treatment for non-small cell lung cancer including chemotherapy, immunotherapy, hormonal therapy, targeted therapies or investigational drugs

Exclusion Criteria:

* Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg, small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or cytological diagnosis of primary lung cancer
* Adenocarcinoma arising from primary sites other than the lung
* Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging System 7th edition)
* Patients with unstable CNS mets within 21 days before randomization
Precision Psychiatry Continuity Clinic Project

This is a demonstration project focused on translating neuroscience insights into clinical practice. The researchers will evaluate how neuroscience assessments may be applied in the clinical setting to help inform care decisions. The aim of the study is to undertake a pragmatic pilot trial to assess whether the inclusion of structured feedback from neuroscience assessments has an effect on improving patient outcomes. The study will investigate how neuroscience assessments can be integrated into and improve clinical care. The impact of sharing information and conclusions from these assessments with psychiatric providers will be explored. Outcomes will include symptoms, social/occupational function and qualify of life.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* Fluent and literate in English, and able to understand task instructions
* fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures)
* Must be referred for treatment at the Stanford Department of Psychiatry Continuity Clinic

Exclusion Criteria:

* Presence of suicidal ideations representing imminent risk
* General medical condition, disease or neurological disorder that interferes with the assessments
* Traumatic brain injury (history of physical brain injury or blow to the head resulting in loss of consciousness greater than five minutes) and which could interfere with doing the assessments
* Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
* Pregnancy
* Presence of acute psychosis, schizophrenia spectrum, or other psychotic disorders
* Concurrent participation in intervention or treatment studies
Insomnia and Cognitive Performance in Chronic Pain

The aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself.

Almost 20 % of the adult European population suffers from chronic pain of moderate to severe intensity, and clinical insomnia has been reported in 53-73% of chronic pain patients. Insomnia seems to be correlated with small to moderate impairments in several cognitive functions involved in working and episodic memory and in attention tasks, and chronic pain has been shown to be associated with objective deficits in memory and executive functioning. The aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself.

Inividuals with complex chronic pain are assessed with a neuropsychological test battery examining different aspects of memory and executive functioning:

The Digit Span subtest from Wechsler's Adult Intelligence Scale III (WAIS-III): Verbal working memory.

Claeson-Dahl Inventory of Learning and Memory (CD): Verbal retention. The Rey Complex Figure Test (RCFT): Visuospatial retention. The Wisconsin Card Sorting Test (WCST): Cognitive flexibility. The Trail-Making Test (TMT): Sustained attention.

The presence of insomnia is examined with the Bergen Insomnia Scale (BIS) , and insomnia severity with the Insomnia Severity Index (ISI). Present pain level at the time of the neuropsychological assessment is quantified using the Visual Analogue Scale (VAS). Pain medication is transformed to the morphine equivalent daily dose (MEDD). Anxiety and depression are assessed with the Hospital Anxiety and Depression Scale.

Eligibility Criteria:
Inclusion Criteria:

* Attending tertiary chronic pain management

Exclusion Criteria:

* None
Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS)

The current study will add to the current knowledge by combining several electrophysiological techniques to examine the relationship between physiological responses and cognitive fatigue and daily activity performance in a stress- and fatigue-inducing protocol.

The aims of this study are: 1) to evaluate the feasibility and usability of assessing physiological responses in an experimental set-up and 2) to investigate the association between physiological outcomes, experimentally induced stress and cognitive fatigue in people with multiple sclerosis (MS) and healthy controls.

In an experimental set-up participants (20 people with MS and 20 healthy controls) will perform a high-challenging cognitive protocol to provoke stress and (cognitive) fatigue.

Physiological responses (heart rate variability, skin conductance, body temperature) and brain activity (EEG) will be measured while resting (resting baseline), while speaking as normal (speaking baseline), during protocol performance and following the protocol (post-protocol).

Demographic and clinical characteristics, as well as levels of perceived fatigue, stress, pain, daily activity performance, quality of life and anxiety and depression will be assessed using medical records and questionnaires.

Feasibility and usability will be assessed in participants and researcher(s) by standardized questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis MS, Relapsing Remitting (RR) type (MS group)
* Expanded Disability Status Scale (EDSS) \<6 (MS group)
* Dutch speaking
* normal or corrected vision
* feasible use of computer

Exclusion Criteria:

* relapse \< 3 months (MS group)
* pregnancy
* relevant comorbidity (thyroid disease, diabetes, other neurological disorders, metabolic diseases, neuro-endocrine tumor(s)
* severe cognitive disability
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone allogeneic or autologous stem cell transplantation

Exclusion Criteria:

* Known or suspected allergy to trial product
* Participation in other trials with unapproved drugs or trials with equal or similar objective
Biofreeze® vs. a Placebo on Chronic Low Back Pain Walking Gait Characteristics and Pain

The purpose of this study is to determine the effect of Biofreeze® versus a placebo on walking gait characteristics and pain during walking in individuals with cLBP.

A convenience sample of 20 participants, 18 years or older with cLBP will be recruited for this study. Participants must have cLBP and be able to perform all study procedures. All interested participants will report in comfortable clothing and sneakers. After explanation of the study and consent, participants will complete the demographics questionnaire, NIH cLBP Minimal Dataset, 10-point Numeric Pain Rating Scale (NPRS), and the Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ). Participants will then complete a 3-minute walking baseline assessment. Following the assessment, participants will rate their pain and be randomly assigned receive a blinded topical of either Biofreeze® or a Placebo. Both the participant and the investigator will be blind to assigned products. The dose of both gels will be 5 mL per side of the low back. The participant will wait 15 minutes, rate their pain, and repeat the 3-minute walking assessment and rate their pain again. Next, there will be a minimum of a 24-72-hour washout period at which time the participants will return and repeat the same protocol using the other topical.

Eligibility Criteria:
Inclusion Criteria:

* must have cLBP and be able to perform all study procedures. CLBP will be defined as pain, muscle tension, or stiffness localized between the lower posterior margin of the rib cage and the horizontal gluteal fold lasting at least 12 weeks and has resulted in pain on at least half the days in the past 6 months

Exclusion Criteria:

* pregnancy, cancer, spinal or hip surgery, or a corticosteroid injection within the past 4 weeks
Environmental Factor and Onset of Spontaneous Pneumothorax

The study aims to evaluate the association between spontaneous pneumothorax onset and weather parameters.

The aim of this study is to analyse the relation between onset of the PSP and exposure to environmental factors such as atmospheric pressure.

A case-crossover epidemiological study will be conducted in 14 French hospitals. SP recorded from 2009 to 2013 will be exhaustively included. Demographic and clinical characteristics will be collected. For each incident case of SP, the period of occurrence of the event (case period) will be compared to several other periods temporally distant from the case period (control periods prior to and after the event). Exposure will be assessed using meteorological stations localized in the vicinity of each patient's home. A potential threshold effect and/or time lag effect between exposure and admission for SP will be explored.

The results of this study will help to identify the meteorological factors associated with the occurrence of SP, and to deepen our knowledge of the pathophysiological mechanisms of SP especially the influence of meteorological factors on bleb rupture.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* first episode of primary spontaneous pneumothorax

Exclusion Criteria:

* Patients with traumatic
* Patients with secondary pneumothorax
* Patients with recurrent pneumothorax and patients with short-term readmissions (recurrence was defined as a new ED admission for the same diagnosis more than 14 days after the first admission).
Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors

The study involves the use of three different dosing regimens of AMG 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. The study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be enrolled in the study with the possibility of enrolling 8 more in each treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced metastatic solid tumor
* Ineligible to receive or progressed on standard of care therapies
* Measurable or non-measurable disease per modified RECIST
* Gallbladder must be in situ on screening ultrasound
* ECOG Performance Status of 0 to 2
* Life expectancy of 6 months or more as determined by the investigator
* Adequate organ and hematologic function as evidenced by laboratory studies prior to randomization
* Men and women 18 years or older

Exclusion Criteria:

* Uncontrolled CNS metastases
* Known history of prior cholecystitis, prior biliary procedure or prior or ongoing biliary disease
* Radiation therapy within 14 days prior to randomization
* Peripheral neuropathy \> Grade 1 per CTC AE v.3
* Currently or previously treated with AMG 706 or other VEGF inhibitors such as SU11248 (sunitinib), PTK787 (vatalanib), AZD2171, BAY 43-9006 (sorafenib), ZD6474 (vandetanib)
* Previous treatment with bevacizumab is allowed if at least 6 weeks have elapsed from the last dose of bevacizumab to the date of randomization
* Any anti-coagulant therapy within 7 days prior to randomization; low dose heparin and warfarin for prophylaxis against central venous catheter thrombosis is allowed
* Less than 30 days have elapsed since participation in an investigational drug/device study or currently receiving investigational treatments
* History of arterial or venous thrombosis within 1 year prior to randomization
* History of bleeding diathesis or bleeding within 14 days of randomization
* MI, CVA, TIA, PTCA/stent, CHF, Grade 2 or greater PVD, uncontrolled arrhythmias or unstable angina within one year prior to randomization
* Uncontrolled HTN defined by a resting BP of \>150/90 mmHg
* Surgery: major surgical procedure within 4 weeks or 28 days prior to randomization; minor surgical procedure, placement of access device or fine needle aspiration within 7 days of randomization; planned elective surgery while on study
* Non-healing or open wound, ulcer or fracture
* Known ongoing or active infection
* Known (+) for HIV, Hep C or Hep B surface antigen
* Known chronic hepatitis
* Known history of allergy or hypersensitivity to AMG 706 or any of its components
* Pregnant, ie, (+) b-HCG; breastfeeding
Change of Fatigue and Physical Fitness in Hospitalized Hematology Patients

The purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness

Cancer-Related Fatigue (CRF) is one of the common distressed symptoms that leukemia patients experienced during the period of chemotherapy. Exercise is the most effective non-pharmacologic treatment but inpatients refuse to do exercise in clinical settings in Taiwan. Decreased physical activity may increase the intensity of fatigue and degenerate the physical fitness; however, there is no study to explore the trajectories of fatigue and physical fitness for leukemia patient during hospitalization. Therefore, the purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness. A longitudinal designed study will be conducted to recruit the leukemia patients in a medical center in Taipei. Eligible patients are those will be going to receive chemotherapy and in hospital at least one week. Time periods for data collection will be in the first 48 hours after hospitalization (T0) and the 48 hours before the patient discharged (T1). A set of structured questionnaire will be used to collected data including the Background information form, the Fatigue Symptom Inventory, the Cancer Fatigue Scale, the Symptom Severity Scale, and the Hospital Anxiety and Depression Scale. Patients will be received physical fitness test including the 6-Minute Walking Test, grip strength, and 30-second chair stand test. The descriptive statistics will be used to analyze the severity of symptom distress, fatigue, and the change of physical fitness, and the inferential statistics was used to analyze the correlation of the symptom, fatigue, and physical fitness. Besides, generalized estimating equations (GEE) will be used to analysis the average of population change of fatigue and physical fitness.

Eligibility Criteria:
Inclusion Criteria:

* Acute leukemia patients with first complete remission status
* Aged above 20
* Be going to receive chemotherapy and in hospital at least one week.
* Those Who willing to participate in the research

Exclusion Criteria:

* Physician consider the patient was not suitable
* Patients' limbs can not move
* Patients' conscious was unclear during hospitalization
* Patient with pain of joint and can't do 30-second chair stand test and 6-Minute Walking Test
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003 studies, enrolling from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.

This study will involve up to 10 annual cross sectional surveys during malaria peak transmission with possible further extension, dependent on the duration of the EPI-MAL-002 and EPI-MAL-003 studies. Surveys will provide point estimates of parasite prevalence and subsequently a longitudinal assessment of the level of endemicity in each area covered by EPI-MAL-002 and EPI-MAL-003. This study will be conducted in parallel to EPI-MAL-002 and EPI-MAL-003 in order to assess parasite prevalence and malaria control measures before (EPI-MAL-002) and after (EPI-MAL-003) vaccine introduction.

By taking into account variations in malaria transmission intensity (MTI) and malaria control intervention coverage, it will enable a more complete assessment of the benefits and risks of the vaccine introduction, and thereby more insight into the potential vaccine impact in EPI-MAL-002/-003, by adjusting incidence data for overall changes in transmission and other malaria control intervention coverage, and assist generalisation of results to other populations.

Eligibility Criteria:
Inclusion Criteria:

* Subjects' whose parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female 6 months to \<10 years of age at the time of survey.
* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.

Exclusion Criteria:

* Child in care.
* Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
Surgeon Compared to Nuclear Radiology Readers for Tc-99m Sestamibi Scans for Parathyroid Disease

The purpose of this study is to analyze the findings of 30 surgeons and 30 nuclear radiologists of 61 individual thyroid scans. The goal is to determine if surgeons are more prone to making a definitive diagnosis based on a given scan than a nuclear radiologist. Accuracy of localization of the two groups will be analyzed. A secure website has been designed to which the physician will be able to login and view and rate the quality of each image and make a localizing diagnosis. Once they are finished, they will not be able to make any more changes, and their responses will be compared to the responses of their colleagues. The results will be analyzed to find if there is a significant variation in the ratings between the surgeons and the nuclear radiologists as to the quality, location, and number of parathyroid glands, if any, on the scans.


Eligibility Criteria:
Inclusion Criteria:

* Must be a surgeon or nuclear radiologist to be eligible read scans for this study.

Exclusion Criteria:

* None
Respiratory Functions, Trunk Control and Mobility Evaluation in Multiple Sclerosis

Respiratory functions and body control are affected in patients with multiple sclerosis (MS). Because of this effect, the dependency of individuals increases in daily living activities and their quality of life decreases.

We think that respiratory functions, respiratory muscle strength and trunk control affect vital mobility as well as vital importance for individuals with MS. As a result of the investigations, it is concluded that the literature is insufficient in this area.

The aim of this study is to investigate the effects of pulmonary function, respiratory muscle strength and trunk control on functional mobility in individuals with MS and compare with healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Having a definite MS diagnosis
* Up to 5.5 points on the Scored Disability Status Scale (EDSS)
* In the last 3 months have not experienced an attack
* Mini mental test score of 24 and above
* Acceptance to participate in the study.

Exclusion Criteria:

* Having orthopedic problems
* The presence of other neurological problems
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression

The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s)
* Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I)
* Participant was \<=six months postpartum.

Key Exclusion Criteria:

* Active psychosis
* Attempted suicide associated with current episode of postpartum depression
* Medical history of seizures
* Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria might apply.