cyrilzakka/clinical-trials huggingface dataset:
Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells

This study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with the Principal Investigator (PI).
* Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.

Exclusion Criteria:

* Under 18 years of age
* Prior surgery on affected knee
* Diabetes
* Root repair, inflammatory arthropathy, or any other concomitant procedure that cannot follow an accelerated PT protocol or any concomitant procedure that the PI deems exclusionary
* Unable to attend physical therapy at Houston Methodist
* Vulnerable populations
* Immunocompromised patients such as those being treated for cancer, kidney failure, etc.
* Heart disease including (systolic blood pressure \>180 mm Hg or heart failure)
* Active infections
* Non-English-speaking patients
* Any known metal implants or allergy to contrast agents
* Pregnancy (as part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative result is required to proceed with surgery per SOC and thus, participate in the study) and those planning to become pregnant during the duration of the study
* Any condition with known bleeding disorders, thrombus formation risk factors, or overlying wound and skin infections
* Any condition in the opinion of the primary investigator that would compromise the integrity of the data collection or outcomes being assessed
Homemade Versus Commercialized Single-access Port Devices in Single-incision Laparoscopic Appendectomy

Homemade and commercialized single-assess port devices are two kinds of port devices commonly used for single-incision laparoscopic appendectomy. This study aimed to compare these two port devices in terms of short-term surgical outcomes and medical costs.

The advantages of homemade port devices include accessibility of the composites and lower equipment costs to the patients; however, the potential disadvantage is the easy leakage of CO2, ballooning of the surgical glove, and device instability, leading to difficult maneuverability. On the other hand, commercialized port devices have relatively easy maneuverability, flexibility for instrument changes, and port stability for long-duration surgery ; however, their higher equipment cost is a disadvantage.

Eligibility Criteria:
Inclusion Criteria:

* The patients were diagnosed as acute appendicitis and undergoing single-incision laparoscopic appendectomy

Exclusion Criteria:

* The patient was not diagnosed as acute appendicitis based on surgical finding or pathological findings
* The patients underwent surgery other than single-incision laparoscopic surgery
Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe

Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 35 to 80 years old
* type 2 diabetes
* HbA1c value between 6.0 % and 9.0 %
* elevated LDL-c values \> 100 mg/dl with no lipid lowering treatment within the last six month

Exclusion Criteria:

* refused informed consent
Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis

This study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with hard brace in terms of three aspects:

1. To assess the efficacy in spinal correction
2. To evaluate the improvement made to the body appearance of AIS subjects
3. To evaluate the impacts on the quality of life (QoL) of AIS subjects

All participants will be fitted with an Ergonomic Brace and required to wear it during the days of experiment only. The ongoing treatment with hard brace will not be substituted with the Ergonomic Brace, unless its immediate treatment effect is equivalent to hard brace and with approval from the doctor.

1. To assess the efficacy in spinal correction

   The efficacy of the Ergonomic Brace refers to the magnitude of spinal correction that could be obtained for patients with AIS. The assessments in this study focus on two aspects, which are i) the in-brace correction and ii) the interface pressure. In-brace correction is used to judge the quality of bracing and also a prognostic indicator for the long-term treatment outcome. Clinical parameters such as Cobb angle, vertebral rotation and trunk listing will be measured with radiographs by a single observer. Interface pressure in this study refers to the pressure between the brace and the trunk of subject. The purpose is to assess the time response of trunk to the intervention of the Ergonomic Brace, and correlation will also be made with the extent of spinal correction.
2. To evaluate the improvement made to the body appearance of AIS subjects

   The trunk aesthetic profile of AIS subjects are being affected by spinal deformities. Surface topography of the subjects will be captured by 3D body scanner, and followed by the evaluation of body aesthetics through the trunk asymmetry scales called POTSI and ATSI index. The purpose is to compare the surface topography change before and after wearing the Ergonomic Brace.
3. To evaluate the impacts on the QoL of AIS subjects

Bracing can negatively affect the QoL of patients with AIS. The Chinese version of Brace Questionnaire (BrQ) will be adopted in this study to compare the impact of hard brace and Ergonomic Brace on the QoL of AIS subjects. Difficulties experienced by AIS subjects during bracing will be highlighted and used for future improvements in scoliosis brace design.

Eligibility Criteria:
Inclusion Criteria:

* Age 10 or older when brace is prescribed
* Risser 0 to 2
* Primary curve angles 25° to 40°
* Female, who were either pre-menarche or less than 1 year of post-menarche
* Undergoing hard brace treatment

Exclusion Criteria:

* Low risk of curve progression
* Non-idiopathic scoliosis (e.g. congenital, neuromuscular deformities)
Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers

This is a randomized, 2-period, 2-sequence crossover study to evaluate the effect of food on the relative bioavailability of BMN 673 during fasting and fed conditions in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male, between the ages of 18 and 55.
* Non-smoking for at least 1 year before Screening.
* Willing and able to provide informed consent.
* Have a BMI between 18 to 30kg/m2.
* Willing and able to comply all study procedures.
* Have adequate organ function
* Sexually active patients must be willing to use an acceptable method of contraception.

Exclusion Criteria:

* History of any illness that might confound the results of the study or pose an additional risk in administering study medication to the subject.
* Current use of prescription medication or regular treatment with over-the-counter medications.
* Consumption of herbal medications or dietary supplements.
* Consumption of more that than 3 units of alcoholic beverages per day.
* Consumption of more than five 240-mL servings of coffee or other caffeinated beverage.
* History of alcohol or drug abuse or addiction within 6 months of study entry.
* Participation in a clinical Study involving administration of an investigational drug within 1 month or 5 half lives (whichever is longer).
* Donation of any blood or having had a significant loss of blood with 56 days.
Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery

The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in CKD patients undergoing cardiac surgery.

Acute kidney injury (AKI)occur 7.7-42% after cardiac surgery. The incidence of AKI requiring renal replacement therapy following coronary artery bypass grafting (CABG) surgery was 0.7-3.5% and increase mortality rate. Erythropoietin (EPO) is now considered a novel anti-apoptotic and anti-inflammatory action. The present study was designed to evaluate the administration of EPO as a means of preventing AKI in these patients.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years.
* serum creatinine levels \> 1.2 mg/dL and baseline creatinine clearance levels \< 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)
* patients who need cardiac surgery

Exclusion Criteria:

* patients with acute kidney injury
* end stage renal disease (requiring dialysis)
* unstable renal function (as evidenced by a change in serum creatinine of \> 0.5 mg/dL, or \> 25%, within 14 days prior to the study)
* allergy to any of erythropoietin
* suffered from congestive heart failure, cardiogenic shock or emergent cardiac surgery.
* receiving erythropoietin within 14 days before the study
Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear

For measuring quality of life in patients with chronic inflammation of the middle ear, only two questionnaires currently exist. However, these questionnaires are designed only to measure either disease-specific health or hearing-related quality of life. The aim of this project is the validation of a pre-existing comprehensive questionnaire, which is routinely administered in the investigators clinic but has never been validated. Following a retrospective item reduction based on existing data, this questionnaire will be prospectively validated. Applying the resulting questionnaire in future studies on chronic middle ear inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of life will be assessed. Therefore, the investigators questionnaire will add substantial information to these outcome studies by providing a subjective outcome parameter.

See Summary that contains all the details

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic otitis media

Exclusion Criteria:

none
Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains

The overarching goal of this multi-disciplinary research program is to develop and optimize new cross-species translational assessments of reward and cognition that will not only be assessed in parallel in humans and rats, but also produce neurophysiological and behavioral metrics that can be objectively compared across species. The research will build on prior studies by further developing and optimizing (in Phase 1), then validating via pharmacological challenge (in Phase 2), the following assays in both humans and rats:

1. advanced neurophysiological and computational modeling techniques to record and analyze EEG activity within and across species; and
2. behavioral assessments of reward learning, cognitive control, and cognitive flexibility will be analyzed within and across species.

The second phase of the study will test the translational validity of these assays, by assessing the impact of a targeted drug on task performance and EEG activity in both species.

The overarching goal of this multi-disciplinary research program is to develop and optimize new translational assessments of reward and cognition that will produce neurophysiological and behavioral metrics that enable objective comparison of drug effects.

Phase 1 (2016-2018) will seek to develop and optimize computer-based tasks to measure of reward learning and cognition, to be administered during an EEG examination. Each participant will be asked to come for a single visit to complete a brief psychological assessment (interview and surveys), then perform two of the computer-based tasks while EEG data are collected. The three tasks are the Flanker Task, the Reversal Learning Task, and the Probabilistic Reward Task (PRT).

In Phase 2 (2018-2021), a new set of participants will be enrolled for four visits. At the first visit they will have a brief psychological assessment (interview and surveys). They will then be assigned to one of the tasks developed during Phase I, and they will also be assigned to one of the study drugs: modafinil (a cognitive enhancer) or methylphenidate (a dopamine enhancer). At the second, third, and fourth visit, the subject will be given their drug in one of the three doses: a low dose, a higher dose, and a placebo. They will then perform the assigned task during an EEG exam.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Right-handed

Exclusion Criteria:

* acute or chronic medical, neurological, or psychiatric illness
* any past/current diagnosis of mental health disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), including alcohol or substance abuse;
* use of any psychotropic medications in the past 6 months
* Current depressed mood (Beck Depression Inventory (BDI-II) score \< 6)
* Current use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants
* History of cocaine, stimulant, and other dopaminergic drug use (e.g., amphetamine, methylphenidate)
* Positive toxicology screen at any session
Far Infrared Irradiation for Stroke Rehabilitation

A stroke is a sudden loss of brain function. It is caused by the interruption of flow of blood to the brain (ischemic stroke) or the rupture of blood vessels in the brain (hemorrhagic stroke). This study will investigate the use of far infrared radiation for stroke rehabilitation.

A stroke is a sudden loss of brain function. The interruption of blood flow or the rupture of blood vessels causes brain cells (neurons) in the affected area to die. The effects of a stroke depend on where the brain was injured, as well as how much damage occurred. A stroke can impact any number of areas including your ability to move, see, remember, speak, reason and read and write.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people with stroke.

Eligibility Criteria:
Inclusion Criteria:

* People with Stroke

Exclusion Criteria:

* None
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis

The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to Week 48) is referred to as the placebo-controlled treatment period of the study. At the beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of Treatment Year 1, participants in the placebo group were re-randomized to receive peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol, all primary and secondary endpoints pertain to Year 1 data.

Eligibility Criteria:
Key Inclusion Criteria:

* Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005)
* Must have an EDSS score between 0.0 and 5.0.
* Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months

Key Exclusion Criteria:

* Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
* Pregnant or nursing women
* Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Combination Iodine 125 Seed Implants and LHRH Agonists for Locally Advanced (Stage T3) Prostate Cancer

Patients with prostate cancer should have the following examination including biopsy, serum PSA volume, prostate CT scan or MRI, bone scan, abdomen ultrasound, chest X ray, blood biochemistry, blood rout, ECG and testosterone.

Two groups:

First group:30 cases should be treated with iodine 125 seed implants 0.5 mc transperineal prostate implant +Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection 1/4weeks).

Second group: 30 cases should be treated with Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection 1/4weeks).

PFS and PSA level will be the primary variables.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent
2. T2c-T3b N0 M0 (biopsy、 bone scan、 CT、 MRI)
3. No Metastasis (bone scan、 CT、 MRI)
4. PSA level\>10ng/ml
5. Histological or cytological confirmation of prostate cancer
6. Able to understand and comply with the requirements of the study

Exclusion Criteria:

1. Having been treated with external radiation therapy or chemistry therapy.
2. Clinical relevant disease and/or abnormalities (past or present), eg, significant cardiovascular, renal or liver disease, malignancy, gastro-intestinal disorders, or other conditions which could affect the absorption/elimination of drugs.
3. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of normal (ULN) at screening findings that make it undesirable for the patient to participate in the study in the opinion of the investigator(s)
4. In the opinion of the investigator(s), any evidence of severe or uncontrolled systemic disease (eg, currently unstable or unresolved respiratory, cardiac, hepatic, or renal disease).
5. Contra-indications (eg, known or suspected allergy) to GnRH antagonists or excipients(non-active ingredients of investigational product).
6. Treatment with a non-approved or investigational drug within 30 days before study entry.
7. Bibulosity or drug abuse.
Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion

The purpose of the study is to design a self-assessment package that could be the preferred option to a follow-up visit at the clinic by the majority of women having early medical abortion.


Eligibility Criteria:
Inclusion Criteria:

1. Already be signed up to do a medical abortion at this clinic
2. Be willing to come to all clinic appointments and be accessible by phone for 2 weeks after sign up for the study
3. Own a cellphone to which will be sent medical abortion-related information and messaging.

Exclusion Criteria:

1. Be doing a medical abortion due to failed natural miscarriage 2. Not have a working cellphone

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Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension

This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PAH of either primary (idiopathic), familial or secondary to systemic sclerosis (excluding those with marked pulmonary fibrosis) according to World Conference on Pulmonary Hypertension classification (Venice, 2003).
* Symptoms with a WHO class of II-IV

Exclusion Criteria:

* Use of unspecific phosphodiesterase inhibitors (for example, pentoxyfillin, enoximon, milrinone or pimobendan) during the study
* Chronic inhaled nitric oxide therapy from start to study completion
* Treatment with catecholamines (for example, adrenalin, noradrenalin, dopamine),
* Pre-existing lung diseases, including parasitic diseases affecting lungs, asthma, congenital abnormalities of the lungs, chest, and diaphragm.
* Pulmonary artery or valve stenosis; pulmonary venous hypertension; chronic thromboembolic pulmonary hypertension
* Acute heart failure or chronic left sided heart failure; congenital or acquired valvular or myocardial disease
* Severe (systemic) arterial hypertension (\> 200 mmHg (systolic) or \> 120 mmHg (diastolic)) Other protocol-defined inclusion/exclusion criteria may apply
To Evaluate the Efficacy and Safety of HSK16149 With L-carnitine in Diabetic Peripheral Neuralgia Patients in China

Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China

Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and voluntarily sign written informed consent;
2. Male or female over the age of 18 (including the threshold);
3. Diabetic peripheral neuralgia (DPNP) diagnosis;
4. The average pain Visual Analogue Scale (VAS) score in the past 24 h was assessed as ≥ 40 mm and \< 90 mm during screening.

Exclusion Criteria:

* 1. Peripheral neuropathy or pain unrelated to DPN that the investigator determined might confuse the DPNP assessment;

  2. History of malignant tumors (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening;

  3. Severe abnormal liver and kidney function, meeting any of the following clinical laboratory test results:
  1. Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN); Or total bilirubin (TBIL) \> 1.5 × ULN;
  2. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 (calculated according to simplified MDRD formula);

  4. Known allergic history to test drug components or other drugs or excipients with similar chemical structure;

  5. Past suicidal behavior or suicidal intention;

  6. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;

  7. Participated in any other clinical studies within 30 days prior to screening;

  8. The researcher determines that there are other conditions that are not suitable for participation in this study.