cyrilzakka/clinical-trials huggingface dataset:
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke. The neurological outcome will be determined after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-70 ischemia stroke or intracerebral hemorrhage patient
* With stroke history of more than 3 months, less than 60 months
* With stable hemiplegia condition
* NIHSS (NIH stroke scale) score of 7 or more points
* Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \<7 mg, and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria:

* Patients aged less than 40 or more than 70
* Lacunar infarction
* History of neurological disease, head injury or psychiatric disorder with disablity
* Pregnant women
* Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition
* Inaccessibility for follow up
* Unwillingness to provide written informed consent
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants with Solid Tumors

The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participant aged 18 years or older.
2. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:

   Part 1:
   1. Combination therapy arms: Selected sarcoma indications from the following 2 separate categories.

      * Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) and synovial sarcoma.
      * Bone sarcoma: Ewing's sarcoma (including extraskeletal), osteosarcoma, and chondrosarcoma.
   2. Monotherapy arms:

      * Sarcoma indications (including those listed for combination therapy arms) regardless of AXL gene amplification status.
      * NSCLC regardless of AXL gene amplification status.
      * Solid tumors (lymphomas participants are excluded) with known AXL gene amplification.

   Part 2:
   1. Combination therapy arms: Sarcoma indications and PAAD.
   2. Monotherapy arms: PAAD, NSCLC and solid tumors with AXL expression.
3. Participants who are refractory to or intolerant to available standard therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.
4. Participants with measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
6. PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.

Exclusion Criteria:

1. History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).
2. Symptomatic central nervous system (CNS) metastases or evidence of leptomeningeal disease (brain magnetic resonance imaging \[MRI\] or previously documented cerebrospinal fluid \[CSF\] cytology). Previously treated asymptomatic CNS metastases are permitted provided that the last treatment (systemic anticancer therapy and/or local radiotherapy) was completed ≥4 weeks prior to Day 1 except usage of low dose of steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and consecutive days is permissible if being tapered down). Participants with discrete dural metastases are eligible.
3. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requiring drainage or associated with shortness of breath).
4. Active diarrhea Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease).
5. Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19

Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.

The researchers will treat 40 patients with metformin (1500 mg/day) and LDN (4.5 mg/day) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19. These 40 patients will be compared with 40 control patients who will receive regular care. All patients will be asked to complete surveys at baseline and after 1, 2, and 4 weeks after initiation of treatment. The difference with baseline at each time point will be assessed. The surveys will assess COVID-19 symptoms severity.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-70
* Any sex
* Any ethnicity
* Adequate cognitive function to be able to give informed consent
* Technologically competent to complete web forms and perform video calls with the PI
* Positive PCR (polymerase chain reaction) test result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) within the last 10 days
* At least two COVID-19 symptoms as assessed by laboratory or patient self-reporting started within the last 3 days
* Willing to fill out regular questionnaires
* Willing to take metformin and LDN

Exclusion Criteria:

* Clinically significant hepatic, renal, or cardiac impairment (as determined by previous clinical judgement)
* Hypoglycemia
* Currently on drugs for COVID-19
* Hospitalization for COVID-19
* (Suspected) pregnancy or breastfeeding
* Active cancer
* Uncontrolled mental health issues
* On any medication with major interactions with metformin or LDN
* Taking opioid analgesics, or being treated for opioid addiction/recovery
* Opioid dependence or withdrawal syndrome
* Known sensitivity to metformin or naltrexone
* Current users of metformin or naltrexone
Genotype and Platelet Reactivity in Patients on Hemodialysis

Patients with end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. We recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted genetic influence in high platelet reactivity in patients with ESRD on HD.

Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. We recently reported platelet inhibition by ticagrelor was markedly greater than by clopidogrel in patients with ESRD on HD. But exact mechanism of high platelet reactivity in ESRD patients was not fully evaluated. A possible postulation would be genetic influence. To investigate this issue, we will evaluate genetic polymorphism in patients with normal kidney function and ESRD on HD according to different doses of clopidogrel and ticagrelor. Genetic test will be assessed polymorphism of ABCB1, PON1, CYP2C19, CYP2C9 and P2Y12.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients undergoing regular (≥ 6 months) maintenance HD
* Matching patients with normal kidney function
* documented coronary artery disease or high risk (Framingham heart risk score ≥ 20%) of coronary artery disease

Exclusion Criteria:

* known allergies to aspirin, clopidogrel, or ticagrelor
* concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
* thrombocytopenia (platelet count \<100,000/mm3)
* hematocrit \<25%
* uncontrolled hyperglycemia (hemoglobin A1c \>10%)
* liver disease (bilirubin level \>2 mg/dl)
* symptomatic severe pulmonary disease
* active bleeding or bleeding diathesis
* gastrointestinal bleeding within the last 6 months
* hemodynamic instability
* acute coronary or cerebrovascular event within the last 3 months
* pregnancy
* any malignancy
* concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
* recent treatment (\<30 days) with a glycoprotein IIb/IIIa antagonist
Acceptability in Dialogues With the Robot EBO

This is a descriptive observational study (first results cross-sectional study, second results longitudinal study). The participants of the study will be exposed to a dialogue with the robot EBO. The user and the therapist's acceptability of the robot, the robot-user interaction during the conversation and the conversation parameters will be assessed.

This is a descriptive observational study (first results cross-sectional study, second results longitudinal study). The participants of the study will be exposed to a dialogue with the robot EBO. The user and the therapist's acceptability of the robot will be measure. Also the robot-user interaction during the conversation and the conversation parameters will be assessed. The assessements will be done at week 0 and at week 3. During weeks 1 and 2 the robot will be present in the therapeutic activities of the center.

Eligibility Criteria:
Inclusion Criteria:

* Users of socio-health centers in Extremadura (Spain).
* Patients with neurological pathology diagnosed by a specialist doctor.
* Over 65 years of age
* Minimental State Examination with a score greater than or equal to 21 (mild-moderate cognitive impairment).

Exclusion Criteria:

* Severe cognitive impairment
* Language impairment that prevents the use of verbal communication.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.

This study was to evaluate the efficacy and safety of intravenously administered ibuprofen 400mg and 800 mg q6h for the management of moderate to severe postoperative pain in Chinese population.

This randomized, parallel, double-blind, placebo controlled multi-center clinical study was conducted in 396 patients scheduled to undergo elective general anesthesia laparotomy or orthopedic surgery. Patients were randomly divided into three groups in radio 1:1:1 received respectively IV placebo, ibuprofen 400 mg or ibuprofen 800 mg. The first dose of study drugs was administered intravenously at the time of wound closure and then every 6 hours within 48 hours after the operation. At the end of surgical suture, 5mg morphine was injected intravenously, and then the patient-controlled intravenous analgesia pump was connected. Efficacy was assessed by morphine dosage during the first 24 hours, pain intensity score, and area under the pain-time curve after surgery. Safety was assessed by the incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment was open to patients undergoing scheduled abdominal surgery (intestinal or lower abdomen) or orthopedic surgery (such as knee arthroplasty or shoulder joint reconstruction) under general anesthesia with endotracheal intubation and were expected to require patient-controlled intravenous analgesia (PCIA) pump for more than 24h for moderate to severe pain after surgery.

Exclusion Criteria:

* Those who can not understand the NRS score and cooperate with the evaluation; those who had head trauma or complicated with organic lesions of the central nervous system within 4 weeks before operation; those who developed coagulation dysfunction or took anticoagulants and antiplatelet drugs; those with a history of severe cardio-cerebrovascular disease, heart failure; those with liver and kidney dysfunction, severe endocrine system diseases, mental illness; those with a history of peptic ulcer or bleeding; those who did not control grade 2 or above hypertension or were still taking two or more of antihypertensive drugs such as angiotensin converting enzyme inhibitors (ACEI), angiotensin converting enzyme antagonists (ARB) and diuretics at admission; Increased toxicity due to the interaction of methotrexate, lithium preparations, etc. with the test drug; use of NSAIDs or analgesic muscle relaxants within 24 hours before operation, narcotic dependence or tolerance; allergy to ibuprofen or other NSAIDs; pregnant or lactating women
CLARITY Imaging Study

OCT image quality is necessary to provide accurate diagnostic information to ophthalmologists. The increasing resolution of imaging techniques will require ever more high standards of optical transmission through the cornea and tear film. Given that lubricant drops can improve optical transmission through the cornea, this study will attempt to quantify this. The primary objective is to assess the effect of cross-linked sodium hyaluronate on OCT image quality compared to the effect of blinking alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients subjectively deemed to have poor image quality by the photographer

Exclusion Criteria:

* Patients with a known adverse reaction to any of the constituents of the XLHA
* Patients wearing contact lenses
* Patients who have used eyedrops in the past 2 hours
Efficacy and Safety of Metformin Versus Empagliflozin on Chronic Kidney Disease Progression

This randomized controlled trial aims at evaluating the efficacy and safety of the antidiabetics metformin versus empagliflozin on chronic kidney disease (CKD) progression in patients with CKD stages 2 or/and 3.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild or/and moderate chronic kidney disease (stages 2 or/and 3, estimated glomerular filtration rate (eGFR) between 30-89 ml/min/1.73 m2) at the time of the baseline visit.
* Patients with and without type 2 diabetes.
* Patients with or without proteinuria.
* Age: ≥ 18 years.

Exclusion Criteria:

* Type 1 diabetes.
* Patients with eGFR ˂30 ml/min/1.73 m2.
* Patients with known hepatic cell failure.
* Decompensated heart requiring acute management.
* Active malignancy.
* Planned coronary or surgical interventions.
* Known hypersensitivity to study medications.
* Chronic inflammation, trauma, or infection.
* Pregnant or lactating women.
* Patients already on metformin or a sodium-glucose cotransporter-2 (SGLT2) inhibitor.
* Any of the study treatments labeled contraindications.
Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder

The purpose of this study is to test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition.


Eligibility Criteria:
Inclusion Criteria:

* Current PTSD
* Current Alcohol Dependence
* at least one heavy drinking day in the past 60 days

Exclusion Criteria:

* Psychotic disorder
* Untreated bi-polar disorder
* benzodiazepine use
Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis

The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Be scheduled to undergo placement of a new straight or loop arm PTFE arteriovenous hemodialysis access graft or a Vectragraft® (Thoratec, Inc.)
* Be currently receiving chronic dialysis or be expected to begin hemodialysis within 4 weeks of placement of the index PTFE graft
* Have undergone an assessment of patency (such as venography) of central veins if any of the following conditions have occurred on the ipsilateral arm intended for graft placement: presence of collateral veins, upper extremity edema or increased size (relative to the contralateral arm), history of subclavian catheter, transvenous pacemaker, or history of trauma or surgery that may have involved the neck or chest veins
* Be \> 18 and \<80 years old
* Have a documented negative serum pregnancy test (for all women of childbearing potential)
* Be using an acceptable method of birth control if of reproductive potential and agree to continue using the birth control for at least 3 months following the graft procedure
* Have agreed to participate voluntarily and have signed and dated an IRB/EC approved, Patient Informed Consent form

Exclusion Criteria:

* Have an intended recipient vein \>6 mm or \<3 mm in diameter
* Have a history of three or more previous PTFE grafts
* Have uncorrected central vein (including the subclavian vein) stenosis
* Have markedly diminished arterial pulses in the access location (unless adequate flow has been documented by arteriography or Doppler ultrasound)
* Anticipate receipt of a renal transplant within 6 months of enrollment into this study
* Have anticipated use of the index PTFE graft \<14 days after enrollment (this does not apply to Vectragraft®)
* Have a known allergy to iodinated contrast
* Have a known hypercoagulable state (e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating lupus anticoagulant; current, active, heparin-induced thrombocytopenia; Protein C or S deficiency; or a history of recurrent deep venous thrombosis not related to AV access)
* Have been in another investigational (i.e., nonapproved) drug or device study within the previous 30 days or prior participation in another clinical study with E2F Decoy
* Have been previously enrolled in this study for an earlier access graft
* Have any comorbid, nonrenal condition that makes 6-month survival questionable (e.g., end-stage cancer, advanced heart failure)
* Have a known or suspected history of drug or alcohol abuse within the previous 6 months
* Have a known allergy to any component of the investigational product (drug or device), including latex
3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.


Eligibility Criteria:
Inclusion Criteria:

* Dysgnathic deformity
* Caucasian
* \> 15 years
* No history of orthognathic surgery
* Informed Consent

Exclusion Criteria:

* \< 15 years
* History of Orthognathic surgery
* Not Caucasian
Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study

OBJECTIVES:

The primary study objective is to collect blood from participants with Huntington's Disease in order to validate a CE marked Cytosine, Adenine, Guanine (CAG) assay for use in future studies for Huntington's Disease.

The secondary study objective is to create a biorepository that can be used to identify disease associated biomarkers and potential targets with immune and multi-omics profiling. The disease sample collection and analysis will be the foundation for an extensive network of biospecimen access and linked datasets for future translational research.

STUDY DESIGN:

* This protocol is a single-center, single-cohort, bioresearch study enrolling up to 5 participants. The cohort is as follows:

  o Cohort 1: Huntington's Disease (n=5)
* The study will enroll participants per the eligibility criteria.
* Participants will have 1 scheduled biospecimen collection visit(s). If the participant requires a recollection or is called for an extra sample donation, this will add additional volume and visit(s) to the collection schedule. The biospecimens collected from participants are whole blood.
* The target blood volume of each phlebotomy visit will be 20 mL. The minimum accepted volume (in the event of tough venipuncture attempts or difficulty obtaining the blood) will be 5 mL. The maximum amount that can be drawn in a 6-week period will be 100 mL (whole blood 6-week maximum).
* Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the cohort before they are considered fully enrolled.

Eligibility Criteria:
Cohort 1: Huntington's Disease

Inclusion:

1. The participant is willing and able to provide written informed consent
2. The participant is willing and able to provide appropriate photo identification
3. Participants aged 25 to 65, inclusive
4. Participants have been diagnosed with Huntington's Disease
5. Patients must have numerical documentation of CAG repeats present in the Medical Record, along with a Huntington's Disease diagnosis.
6. Pre-existing evidence of CAG repeats should be in the range of 40-60 repeats \*Preference (not required for enrollment): Patients to have different CAG repeats from each other but this is not essential.\*

Exclusion:

1. Participants who are pregnant or are nursing
2. Participants with a known history of HIV, hepatitis, or other infectious diseases
3. Participants who have taken an investigational product in the last 30 days
4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
Evaluation of a Nutraceutical for Endometriosis Pain Relief

Based on the EHP-30 questionnaire, the pain score and general well-being of all patients will be assessed with and without taking a specialized nutraceutical. These patients will be taking continuous oral contraception, for 3 months before inclusion till at least end of the study or not taking any oral contraception at all during the study due to contraindication(s).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed endometriosis and/or Positive NMR
* 18-49y
* Mean pain score \>6 on the assessment of pelvic pain (Visual analogue scale)
* Not eligible for surgery in the coming 3 months or had surgery \>3 months before inclusion in the study
* \>3 months intake of continue oral contraception (Oestrogen/Progesterone) before inclusion or no intake of oral contraception due to contraindication
* Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Planned surgery during study
* \<3 month intake of continue oral contraception (Oestrogen/Progesterone) before inclusion
* Chronic inflammatory disease (Chron's disease, Rheumatism,..)
* Pregnancy
* Bariatric surgery
* Malabsorption issues
* Allergy or hypersensitivity to the study product:
* Fish and products thereof: fish oil
* Soybeans and products thereof
* Alcohol or substance abuse
* Start of gonadorelin analogue (ex. Busereline, Gosereline, triptoreline) therapy in the past 6 months
* Intake of other food supplements, including omega 3 and omega 6
* Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject