cyrilzakka/clinical-trials huggingface dataset:
Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic HSCT

Allogeneic hematopoietic cell transplantation offers high cure rates for patients with hematological and oncological diseases. Graft-versus-host disease (attack of donor's white blood cells on patient's tissues) is a serious complication also affecting the patient's immune system. Therefore, patients in the early phase after allogeneic cell transplantation are at high risk for severe infectious complications. So far, no predictive biomarkers for the development of the chronic form of graft-versus-host disease are available. By analysing serially immune cell populations of the peripheral blood we will investigate whether certain subsets of cells are associated with development of chronic graft-versus-host disease. In addition, the patients' immune regeneration will be evaluated by serial analyses of peripheral blood immune cell populations 3 months to 2 years after allogeneic cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Receiving grafts from either HLA-identical sibling donors or HLA-matched unrelated donors
* Receiving grafts from HLA-mismatched sibling donors or HLA-mismatched unrelated donors
* Receiving either bone marrow, peripheral blood stem cells or cord blood grafts
* Alive on day 100 after transplant
* Age 18 years or above
* Signed written informed consent

Exclusion Criteria:

* Lymphocytopenia not allowing immunophenotyping
* Treatment with rituximab after HSCT until study entry
* Hepatitis B and C, HIV infection
* Secondary posttransplant malignancies including EBV-lymphoproliferative disease
* Karnofsky score of 30 or below
* Absence of informed consent
Storytelling and Mindfulness for Graduate Student Wellbeing

The purpose of this study is to evaluate an intervention for improving Science, Technology, Engineering, and Math (STEM) graduate student wellbeing. Participants will be recruited from the University of Wisconsin-Madison graduate student body. Data will be collected from participants for up to 2 years, and the investigators anticipate that the study will last for 4 years.

The objective of this research is to evaluate the utility of storytelling and mindfulness practice in improving wellbeing in STEM graduate students. The main questions it aims to answer are:

1. Does engaging in mindfulness practice and storytelling increase measures of wellbeing in this population?
2. Does engaging in mindfulness practice and storytelling increase measures of academic success?

Participants will be asked to:

* complete a survey evaluating wellbeing and academic success
* attend 2 storytelling workshops
* use a guided mindfulness mobile app for 2 weeks

Researchers will compare survey results from participants in the control group (no intervention, survey only) to those from participants in the intervention group (workshops, mindfulness, and survey) to see if the measures of wellbeing and academic success differ between groups.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Current graduate student in a Science, Technology, Engineering, and Math (STEM) field at the University of Wisconsin-Madison
* No significant experience with mindfulness practice

Exclusion Criteria:

* Under 18
* Significant experience with mindfulness practice
* Not a current graduate student in a STEM field at the University of Wisconsin-Madison
Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling in the Intensive Care Unit

Critically ill patients in the intensive care unit are known to lose muscle mass and function at a rapid rate. Currently, there is a global recognition and shift in the ICU culture to reduce sedation and encourage exercise and mobilization early during the ICU stay. Functional stimulation assisted supine cycling can be applied to patients in the bed and does not require patient participation. This study seeks to evaluate the effect of conventional exercise and early mobilization in combination with functional stimulation assisted supine cycling applied early during the ICU on muscle mass, strength, and physical function, as well as patient-reported disability as compared to conventional exercise and early mobilization alone.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Admitted to the ICU with a predicted ICU length of stay ≥ 4 days
* Expected to survive the ICU stay
* Expected to receive mechanical ventilation \> 48 hours
* Able to perform physical outcome measures pre-morbidly (with or without an assisted device)

Exclusion Criteria:

* Proven or suspected neuromuscular weakness affecting the legs (eg- stroke or Guillain-Barré syndrome)
* Lower limb amputation(s)
* Assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 36 hours
* Pregnancy
* Body mass index \> 40
* Presence of external fixator or superficial metal in lower limb
* Open wounds or skin abrasions at electrode application points
* Presence of pacemaker or implanted defibrillator
* Transferred from another ICU after \>48 hours of consecutive mechanical ventilation
* Lower limb malignancy
* Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions
* Body habitus unable to fit the bike
* Palliative goals of care
* Unable to participate in FESC within 48 hours of ICU admission due to logistic reasons or due to failure in daily screening for participation
An Observational LTFU Study for Patients Previously Treated With Autologous ex Vivo Gene Therapy for ADA-SCID

This observational long-term follow-up study is designed to collect safety and efficacy data from ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS-ADA LV encoding for human adenosine deaminase (ADA) gene (EFS-ADA LV), as part of the OTL-101 clinical development program. No investigational medicinal product will be administered to these patients as part of the OTL-101-6 study.


Eligibility Criteria:
Inclusion Criteria:

A patient is eligible for enrollment in the study if all of the following criteria are met:

1. the patient has been treated with an autologous ex vivo gene therapy product based on the EFS-ADA LV, as part of the OTL-101 clinical development program;
2. the patient displays persistent detectable gene marking, as determined by the Investigator;
3. the patient or, if applicable, the patient's parent(s)/legal guardian(s), are able and willing to provide informed consent.

Exclusion Criteria:

* There are no exclusion criteria for participation in this observational LTFU study.
Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19

COVID-19 infection has been associated with numerous cardiac manifestations. Indeed, SARS-CoV-2 may impact on cardiovascular system through a direct myocardial infection or a secondary cardiac involvement due to hypoxia or metabolic supply-demand imbalance or prothrombotic inflammatory state. As a consequence of and besides acute myocardial damages, COVID-19 could also determine chronic cardiovascular consequences, with a significant impact on long-term prognosis, quality of life and functional capacity of COVID-19 survivors.

On this basis, we aim to define the clinical and prognostic effects of myocardial involvement in COVID-19 patients.

COVID-19 infection has been associated with numerous cardiac manifestations. Indeed, SARS-CoV-2 may impact on cardiovascular system through a direct myocardial infection or a secondary cardiac involvement due to hypoxia or metabolic supply-demand imbalance or prothrombotic inflammatory state. As a consequence of and besides acute myocardial damages, COVID-19 could also determine chronic cardiovascular consequences, with a significant impact on long-term prognosis, quality of life and functional capacity of COVID-19 survivors.

On this basis, we aim to define the clinical and prognostic effects of myocardial involvement in COVID-19 patients, with a 1-month and 6-month follow-up composed of clinical evaluation, electrocardiogram, trans-thoracic echocardiogram, cardiovascular magnetic resonance, chest computerized tomography scan and cardiopulmonary exercise test.

Eligibility Criteria:
Inclusion Criteria: patients who were hospitalized for COVID-19

Exclusion Criteria: None.
Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage

This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Patients who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

Exclusion Criteria:

* Patients who did not enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
Diaphragm Sparing Effect of Subomohyoid Block With Infraclavicular or Subscapularis Blocks in Comparison With Interscalen Block for Postoperative Analgesia in Shoulder Surgeries

The gold standard for shoulder analgesia is the interscalene block (ISB), but it has its own share of disadvantages such as phrenic nerve block, recurrent laryngeal nerve involvement and Horner's syndrome may lead to patient discomfort .Others, such as intrathecal spread and systemic toxicity of local anesthetic, can have serious consequences.

Phrenic nerve injury is a common complication with regional anesthesia. Its either temporary with Transient Phrenic Nerve Palsy leading to hemidiaphragmatic paresis after interscalene block or other injections of local anesthetic in the neck .

Although studies of ISB have shown a reduction in the incidence in hemidiaphragmatic paralysis with low-volume ISB, the risk of phrenic paralysis is not completely eliminated.

To bypass this complication, distal block of the shoulder innervation is recommended such as subomohyoid infraclavicular and subomohyoid subscapularis blocks.

Ultrasound has a significant role in recent anesthesia. It plays a significant role in detecting diaphragmatic mobility and detecting phrenic nerve palsy after regional anesthesia . the common and standard technique for shoulder analgesia is interscalen block. but it has its own complications like phrenic nerve palsy.

to bypass this complications ,several ways had been tried to overcome this complications.

in this study, the investigator compare between the standard interscalen block with distal blocks like infraclavicular subomohyoid block and subomohyoid subscapularis blocks according to diaghragm affection , duration of analgesia , side effects occured with blocks.

For infraclavicular subomohyoid block, the infraclavicular approach targets the posterior and lateral cords, thus anesthetizing the axillary nerve (which supplies the anterior and posterior shoulder joint), whereas the suprascapular nerve block done by blocking subomohyoid muscle anesthetizes the posterior shoulder.

For subscapularis subomohyoid block, subscapularis is done before subomohyoid block. Subscapularis block target subscapular nerve which arise from posterior cord and present on ventral surface of subscapularis muscle .

Eligibility Criteria:
Inclusion Criteria:

* Patient acceptance.
* ASA I and ASA II.
* Age 21-60 years old.
* Both gender.
* BMI \< 35 Kg/m2.
* Accepted mental state of the patient.
* Elective Unilateral upper limb surgeries at the level of the shoulder.
* Time of surgery less than 2 hours

Exclusion Criteria:

* - Patient refusal.
* Peripheral neuropathy.
* Pathological coagulopathy.
* Infection at the injection site.
* Untreated pneumothorax.
* Disturbed conscious level.
* An allergy to local anesthetics used in this study
Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration

To evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD).

This study is an open label, prospective pilot study to evaluate retinal function after PBM treatment in eyes with dry AMD using ERG. The target enrollment is 15 subjects in up to two sites in the US. All subjects will receive PBM Treatment.

Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over 3 weeks.

The primary analysis will examine multi-focal ERG function changes from baseline to Month 1. Secondary analyses will examine multi-focal ERG function change from baseline to Month 3 and 6. Other endpoints will include other functions of ERG, ETDRS Visual Acuity, Contrast Sensitivity, Perimetry, Color Vision test and the Amsler grid test.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 50 years of age at Screening visit
* ETDRS BCVA letter score of between 50\* and 75\* (Snellen equivalent of 20/100 to 20/32)
* Diagnosis of dry AMD
* Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
* Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines

Exclusion Criteria:

* Current or history of neovascular maculopathy
* Presence of center involving GA within the central ETDRS 1 mm diameter at Screening
* Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s)
* Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s)
* Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
* Visually significant disease in any ocular structure apart from dry AMD
* Serious medical illness that will prevent the subject from performing study activities
* Presence of or history of malignancy within the past 5 years
* Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if they have a history of light activated CNS disorders (e.g. epilepsy, migraine)
* History of neurologic condition known to affect visual function
* History of drug, alcohol or substance abuse within 3 months prior to Screening
* Participation in any other clinical study at time of screening, or has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
* In the opinion of the Investigator, is unlikely to comply with the study protocol
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac

Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine)


Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary osteoarthritis of knee with grade I-III of Kellgren \& Lawrence criteria
2. Not during breast feeding
3. Not during pregnancy with a good contraception
4. Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver function tests and renal funtion tests
5. Do not abuse drugs
6. Good cooperation

Exclusion Criteria:

1. BMI \> 32
2. History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
3. History of allergy diclofenac or allergy herbal medicine
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
* Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight
* Subjects \> 24 months of age
* A negative serum pregnancy test for any female subject who is of childbearing potential.

Exclusion Criteria:

* Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
* Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory. An AST \> 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
* Subjects with neutropenia (defined as an ANC \>= 1,000/mm3)
* Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
* Subjects with malignancy or a history of malignancy
* Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry
* Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions
* Subjects with selective complete IgA deficiency
* Subjects with moderate levels of anti-IgA antibodies (\>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this)
* Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment
* Subjects who receive prophylactic antibiotics as part of their care regimen
* Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry
Post-Market Evaluation of the EVO ICL

The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).

This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to high myopia correctable with available EVO ICL powers.
* Moderate to high myopic with astigmatism correctable with available EVO ICL powers.
* Stable refractive history within 0.50 D cylinder for 1 year prior to implantation.
* Stable refractive history within 0.50 D for spherical equivalent 1 year prior to implantation.
* Able and willing to return for scheduled follow-up examinations after surgery.
* Able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular hypertension or glaucoma.
* Insulin dependent diabetes or diabetic retinopathy.
* History of previous ocular surgery.
* Monocular.
* Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
* Other protocol-specified exclusion criteria may apply.
Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers

A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis

  * HNVs with a screening blood pressure less than 140/90 mm Hg
  * Subjects who have hypertension controlled with up to 1 medication and who have a blood pressure less than 140/90 mm Hg
  * Note: For subjects with blood pressure at or above 140/90 mm Hg; two additional readings 5 minutes apart are allowed but the last blood pressure reading must be in range
  * Subjects who have hypercholesterolemia controlled with up to 1 medication and who have a low-density lipoprotein value less than 160 mg/dL
* Good venous access for blood draws
* No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing \< 100 ng/mL
* Body mass index (BMI) \< 32 kg/m2
* Completion of informed consent form

Exclusion Criteria:

* Blood donation (500 mL) within the last 8 weeks
* Fasting blood sugar \>100 mg/dL
* History of coronary artery disease, peripheral vascular disease, or congestive heart failure
* Allergy to study drug, components of Boost and Boost Plus, or other study material
* Clinically significant active or chronic illness
* History of asthma, COPD, or any other clinically relevant chronic lung disease
* Respiratory tract infection within 4 weeks before screening
* History of drug or alcohol abuse within the past 5 years
* Positive urine drug screen
* Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
* Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism
* History of malignancy within the 5 years before screening (other than basal cell carcinoma)
* History of human immunodeficiency virus (HIV) infection or hepatitis B or C
* Women who are pregnant, lactating, or planning to become pregnant during the clinical study period
* Women of childbearing potential (premenopausal who have not undergone hysterectomy or bilateral tubal ligation, or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile.
* Any subject who, in the opinion of the PI or a designee, appears not to be qualified for this study