cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Plasma Exchange in MG

The primary objective of the study is to longitudinally profile immunoglobulin levels and autoantibody levels in subjects with myasthenia gravis (MG) who receive therapeutic plasma exchange (TPE).

This is a prospective, multi-center, pilot biomarker study in subjects receiving TPE for the treatment of MG. No study medications will be given.

Ten (10) AChR antibody positive MG subjects will be enrolled in the study at 2 sites. Of these 10 MG subjects, up to 5 may be receiving chronic TPE.

The study period will be approximately 3 months and will consist of:

* Screening/baseline visit,
* TPE visit where subjects will undergo clinical evaluations and blood draws for immunological assays,
* End of TPE visit where information on the TPE procedure will be recorded, clinical measurements will be performed, and a blood sample will be drawn.
* Post-TPE period where subjects will undergo clinical evaluations and blood draws for immunological assays at week 1, week 2, week 3, week 6, and week 12 after TPE.

Study procedures performed outside of usual care will include optional single-fiber electromyography (SFEMG) studies, blood draws and optional skin biopsies.

Eligibility Criteria:
Inclusion Criteria:

* has the capacity to understand and sign an informed consent form
* 18 years or older
* diagnosis of MG based on clinical features
* has detectable serum autoantibodies to AChR
* has a clinical indication for the use of TPE to treat MG

Exclusion Criteria:

* unable or unwilling to comply with study procedures that include multiple venipunctures
* weighs less than 50Kg
* has a contraindication to treatment with TPE (e.g. clinically significant bleeding disorder)
* has muscle specific tyrosine kinase or low-density lipoprotein receptor-related protein 4 (LRP4) antibody positive MG
* has prior or current history of thymoma
* had a thymectomy in the past 6 months
* has received rituximab in the past 12 months
* has another coexisting autoimmune disease that is not clinically controlled or may preclude accurate study assessments according to the judgment of the PI
* has current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or central nervous system disease
* has participated in an interventional clinical trial with a novel therapeutic agent in the past 6 months
* is cognitively impaired, a prisoner, or otherwise institutionalized at the time of screening
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer.

The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug and its experimental combinations
* How much study drug and fianlimab is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations


Eligibility Criteria:
Key Inclusion Criteria:

1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Adequate organ and bone marrow function, as described in the protocol
5. Platinum-Resistant Ovarian Cancer, as described in the protocol

Key Exclusion Criteria:

1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug(s)
2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study drug(s)
3. Another malignancy that is progressing or requires active treatment, as described in the protocol
4. Untreated or active primary brain tumor, Central Nervous System (CNS) metastases, or spinal cord compression, as described in the protocol
5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency

NOTE: Other protocol-defined inclusion/exclusion criteria apply
Rural Engagement in Primary Care for Optimizing Weight Reduction

The purpose of this study is to compare three methods for managing obesity in rural patients, to see which method will result in patients being able to attain their weight loss goal and maintain that weight loss.

Nearly 20% of the U.S. population lives in rural communities. Rural residents suffer at a higher rate from obesity and obesity-related illnesses, including diabetes, heart disease, and arthritis. Local primary care physicians are an important resource for treating obesity in rural areas because of a lack of other community resources.

This study is looking at how effective current, real-world primary care treatment models are in helping rural residents lose weight and maintain that weight loss. Physician clinics will be randomized (like picking numbers from a hat) to conduct one of the three methods. The method a participant is part of will depend on the method their physician's clinic is randomized to. The three methods involved in this study are:

1. Individual weight-management counseling in person (in clinic individual visits)
2. Group weight-management counseling, both in person and by telephone; the latter if preferred by the group (in clinic group visits)
3. Group weight-management counseling by telephone (phone group visits)

Participants will be in the study about 24 months. The number of in-person clinic visits and phone calls each participant will be asked to complete depends on the method.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 30 kg/m2 and 45 kg/m2.
* Live in a rural location.
* Have clearance from their primary care provider to participate in a diet and exercise weight control intervention.
* Have access to a telephone.
* One individual per household will be permitted to enroll in the study.

Exclusion Criteria:

* History of heart attack in the last six months, stroke in the last six months, or new cancer diagnosis in the last six months.
* History of bariatric surgery or planning bariatric surgery in the next two years.
* Pregnancy within the last six months or planned within the next two years or currently pregnant or lactating.
* Serious medical conditions where weight loss is contraindicated.
* End stage renal disease or end stage liver disease.
* Other medical contraindications as determined by the patient's primary care physician (PCP); documented PCP clearance will be obtained.
* Participants who are already enrolled in, or planning to enroll in another research study where weight loss is targeted.
* Participants who plan to relocate outside of their provider's service area or who plan to leave their primary care clinic in the next 2 years.
* Unable to read and understand English.
A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia

To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).

This is a double-blind, randomized, placebo-controlled, parallel-group study. The study consists of two groups of subjects with Major Depressive Disorder randomized to treatment with either eszopiclone 3 mg or placebo nightly at bedtime for 31 weeks beginning the night of Visit 2. In addition, all subjects will receive open-label treatment with venlafaxine. Safety and efficacy will be evaluated using clinical observations as well as physician and subject administered ratings scales. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
* Subjects must have a primary diagnosis of Major Depressive Disorder (MDD) by DSM-IV criteria (296.XX) as determined by the Mini International Neuropsychiatric Interview (M.I.N.I.).
* MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
* Subjects must have a 17-item Hamilton Depression Scale (HAM-D-17) total score of \> 22 at the screening visit.

Exclusion Criteria:

* Subjects who have a HAM-D-17 total score \< 18 at Visit 2 will be discontinued from the study.
* All subjects who do not meet DSM-IV criteria (307.42) for Insomnia related to a Major Depressive Disorder.
* Subjects with less than a total sleep time \< 6.5 hours at least three times per week over the past month.
RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe

To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.


Eligibility Criteria:
Inclusion criteria:

1. ≥ 18 years old.
2. Patients with metastatic papillary renal cell carcinoma, type I or II.
3. Patients with at least one measurable lesion.
4. Patients with an ECOG Performance Status ≤1.
5. Adequate bone marrow function.
6. Adequate liver function.
7. Adequate renal function.
8. Adequate lipid profile.

Exclusion criteria:

1. Patients who had radiation therapy within 28 days prior to start of study.
2. Patients who have received prior systemic treatment for their metastatic RCC.
3. Patients who received prior therapy with VEGF pathway inhibitor.
4. Patients who have previously received systemic mTOR inhibitors.
5. Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
6. Patients with uncontrolled central nervous system (CNS) metastases.
7. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
8. Patients with a known history of HIV seropositivity.
9. Patients with autoimmune hepatitis.
10. Patients with an active, bleeding diathesis.
11. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
12. Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
13. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
14. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
15. Patients unwilling to or unable to comply with the protocol.
Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

RATIONALE: Learning how often patients experience nausea and vomiting after receiving anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better treatment and improve patients' quality of life.

PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.

OBJECTIVES:

* To assess the prevalence of delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-emetic medications during the first course of an oxaliplatin-based chemotherapy regimen (mFOLFOX6 or FOLFOX7).

OUTLINE: This is a multicenter study.

Patients undergo collection of demographic, diagnostic, and treatment data at baseline. Patients complete the Functional Living Index-Emesis (FLIE) questionnaire at baseline prior to first chemotherapy infusion and at 5-7 days. Patients also fill out daily patient diaries about symptoms of nausea and vomiting, and use of medications to prevent these symptoms over days 1-5.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colorectal cancer
* Currently receiving OR scheduled to receive the first course of either of the following chemotherapy regimens:

  * mFOLFOX6
  * FOLFOX7
* No clinical or imaging evidence of brain metastasis

PATIENT CHARACTERISTICS:

* Able to maintain a diary and complete a standardized quality of life questionnaire in English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 90 days since prior aprepitant
A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training

A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.

The objective of this study is to clinically assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program, and investigate the acceptance from patients and therapists. Total of 7 patients will be recruited in this study, all the patients will receive 1.5 hours of standard therapy together with 0.5 hour of robot therapy every day. The robot therapy will be a 30 mins long session for 3 to 5 days per week over a period of six weeks. The study will include forearm pronation-supination and wrist flexion-extension training.

Eligibility Criteria:
Inclusion Criteria:

* Sub-acute and chronic stroke patients
* Able to rest comfortable in training set-up
* Mini-Mental Status Examination (MMSE) Score (\>21)
* Motor Assessment Scale (Balance sitting \>3)
* Modified Ashworth Scale (Wrist \< 2)

Exclusion Criteria:

* Contractures in affected upper extremity which inhibit movements being tested
Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.

This study evaluates the work of breathing among patients under various conditions of treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is a cross over of four treatment periods with different flow settings.

High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in PaCO2. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.

The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing.

The investigators will evaluate the baseline status with conventional oxygen therapy methods (low flows), and then compare it with three different levels of high flow oxygen therapy in a randomised order. The primary endpoint will be the work of breathing.

Eligibility Criteria:
Inclusion Criteria:

Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with

* either hypoxemia (SpO2\<90% with O2≥3L/min) ;
* or hypercapnia (PaCO2\>45 mmHg with a respiratory acidosis (pH\<7,38).

Exclusion Criteria:

* Patients below 18yo, pregnant or breastfeeding women;
* Patients enrolled in another study excluding co-enrolment;
* History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
* Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax);
* Need for immediate intubation or for continuous noninvasive ventilation and/or recent (\<6h) arterial blood gases showing a respiratory acidosis with a pH\<7.30;
* Patient feeling nauseous or under recent fed condition (\<1h).
Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

The purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time. Meeting this goal will allow for improved risk categorization, prediction of relapse, and measurement of disease progression in a lifetime prevalence population.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.
* Enrolled in the MoodNetwork

Exclusion Criteria:

* Report positively on the QIDS-SR suicide item during study intake
* Total score greater than 15 on the QIDS-SR during the screening process
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion

The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion prosedure in comparison with bone autografts and synthetic material based on β-TCP

An open-label non-randomized controlled clinical trial will be conducted with two groups of patients. Following enrollment based on specific indication criteria, all patients will undergo surgical treatment (spinal fusion) using either bone substitute "Histograft" (for spinal fusion of cervical and lumbar spine) or bone autograft (for spinal fusion of lumbar spine), or synthetic material based on β-TCP (for spinal fusion of cervical spine). The primary outcomes will involve the bone fusion rate evaluated with computer tomography (CT) at 6 and 12 months. For the safety assessment, the frequency of serious adverse events (SAEs) and adverse events (AEs) will be monitored throughout the entire clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* signing the informed consent
* indications for spinal fusion: degenerative-dystrophic diseases of the cervical and lumbar spine.

Exclusion Criteria:

* refusal to sign IP
* age less than 18 years
* history of spinal surgery in the area of planned spinal fusion
* decompensated forms of chronic diseases
* oncological diseases with identified metastases or risk of metastasis
* patient's refusal to participate in the study
Extension of EMDR vs. PC For Motor Vehicle Accident Trauma

This is an extension of a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. The purpose of this extension is to add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to see a) if that has any impact on participant retention, treatment effectiveness, or treatment efficiency; and b) if such impact is equivalent with EMDR and PC.


Eligibility Criteria:
Inclusion Criteria:

* adult reporting distress related to motor vehicle accident-related trauma
* English-speaking

Exclusion Criteria:

* already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method
* any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview)
* any indication of instability during interactions prior to the therapy session
* an average score on the Dissociative Experiences Scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder
Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19

The purpose of this study is to evaluate the safety, immunogenicity, and efficacy of Nanocovax vaccine in volunteer subjects 18 years of age and older.

This is a phase 3, adaptive, multicenter, randomized, double-blind, placebo control study to evaluate the safety, immunogenicity, and efficacy of the Nanocovax vaccine against COVID-19 in volunteer subjects 18 years of age and older.

Age stratified as 18-45, 45-60, and \> 60 years of age.

The assessment of immunogenicity will be further expanded in a subset of Phase 3 (1000 participants).

Randomly assigned to vaccine or placebo group with a ratio of 2:1 (2 subjects injected with Nanocovax 25 mcg : 1 subject injected with placebo).

Eligibility Criteria:
Inclusion Criteria:

* Be a male or female 18 years of age or older.
* For females: Be of non-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through 6 months after completion of the vaccine series.
* Willingness to provide a signed, printed, and dated informed consent form.
* Able and willing to participate in all activities in the clinical trial.
* Participants with HIV, HBV, HCV should have a health record, determined to be stable for 6 months prior to the screening.

Exclusion Criteria:

* Participants with unstable pre-existing medical conditions over the three months before enrollment (condition that has worsened to require hospitalization or significant changes in therapy).
* Planned administration/administration of a vaccine not foreseen by the study protocol from within 45 days before the first dose of study vaccine.
* Previous vaccination with any Covid-19 vaccine.
* History of COVID-19 disease.
* History of allergic reactions or anaphylaxis to previous immunizations or allergies to any components of the vaccine.
* Planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase through 6 months after the second immunization.
* History of bleeding disorders/hemostasis or use of anticoagulants.
* Currently having cancer or undergoing cancer treatment.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose (inhaled and topical steroids are allowed).
* Women who are pregnant or breastfeeding.
The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue

This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing the norepinephrine transporter.


Eligibility Criteria:
Inclusion Criteria:

* age 18-30 yrs
* BMI \< 24 kg/m2
* Caucasian

Exclusion Criteria:

* Current neuro-psychiatric illness
* substance abuse
* medical or neurological illnesses likely to affect physiology or anatomy, i.e., uncontrolled hypertension, cardiovascular disorders
* current pregnancy
* current breast feeding
* suicidal ideation or behavior
* use of medications which potentially affect NET binding within 2 weeks of the PET scans.