cyrilzakka/clinical-trials huggingface dataset:
Analysis of Joint Sounds in the Diagnosis of Knee Disorders

Clinical-noninvasive recording of sounds from the knees through a brief loaded range of motion. Description in phase 1 analytic but descriptive as well in phase 2. No samples other than a sound recording. The device is known microphone attached to the skin of the knee with elastic material. Sound recorded and analyzed on a lap top computer with Adobe software.

There is a need for a less expensive and more universally available screening device for the knee, and other joint pathology. The equipment used for ultrasound is much less expensive and cumbersome than that of an x-ray or magnetic resonance imaging. The equipment we will use for the analysis of sound produced by the body itself is an order of magnitude less expensive than ultrasound; such as a laptop computer with currently available software and an inexpensive transducer. Analysis of sound has proved useful in Pulmonology and Cardiology. We believe sound analysis will provide a useful yet inexpensive tool for primary care physicians as well as musculoskeletal specialists.

Phase 1: Establish the normal sound patterns emanating from the uninjured knee; we will look for the influence of age, height and weight.

Phase 2: To record and analyze the preoperative sound patterns from the knees with pathology, known by MRI and arthroscopy, then compare them with the normal sounds from Phase 1.

Eligibility Criteria:
Inclusion Criteria:

Phase I

* Healthy Individuals.
* No neurological problems.
* No knee complaints.
* No previous Surgery or Knee injuries.

Phase II Patients undergoing knee arthroscopy who have pre-op MRI. The inclusion will be based on age group, 20 years of age, 40 and 60.

Exclusion Criteria:

* Neurologic Disease
* Previous serious injury (Fracture or dislocation).
* Previous Ligament reconstruction.
* Major non-subtitle problems with their knees. (This would create overwhelming noises).
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.

The primary objective of the study is to evaluate the effect of hetrombopag on pharmacokinetics of healthy Chinese adult subjects after oral administration of rosuvastatin calcium tablets. The secondary objective of the study is to evaluate the safety of rosuvastatin alone and when co-administered with hetrombopag.

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
* Ability to complete the study as required by the protocol;
* Healthy male or female subjects aged 18 to 55 (including 18 and 55) at the date of signing the informed consent;
* Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26).

Exclusion Criteria:

* Allergic constitution;
* History of drug use, or drug abuse screening positive;
* Alcoholic or often drinkers;
* History of deep vein thrombosis, or any other thromboembolic event;
* A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
* Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer

To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.
* Subjects with prior resection of brain metastases with progressions on brain MRI.
* Histologic confirmation of breast cancer.
* Age of study subject must be \> 18 years.
* ECOG Performance Status ≤ 2.
* Ability to undergo brain MR and PET imaging
* Study subjects must have normal organ and marrow function as defined below:

WBC \>2,000/mmᶟ, platelets \>90,000/mmᶟ, total bilirubin \<2.0 mg/dl, creatinine \<2.0 mg/dl.

* The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.
* Ability to understand, participate and provide a documented signed informed consent.
* Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.

Exclusion Criteria:

* History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.
* Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.
* Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.
* Subjects who are unable to provide informed consent.
* Patients with prior whole brain radiotherapy.
* Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²
An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms

Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation (iTBS) to treat negative symptoms in schizophrenia. In this study, we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms.

We propose a pragmatic, open label and single arm clinical trial. Forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days. Participants will be followed up immediately, 1 month and 3 months after the end of treatment. Clinical assessment includes, BNSS, The Brief Negative Symptom Scale; SANS, Scale for the assessment of negative symptoms; SAPS, Scale for the assessment of positive symptoms; PANSS, Positive and Negative Symptoms Scale; MoCA, Montreal Cognitive Assessment scale; CDSS, Calgary Depression Scale for Schizophrenia: SDS, Sheehans' disability scale and EQ-5D. The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS, negative symptoms subscale immediately after the treatment.

This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥21 and ≤65 years;
2. With primary diagnosis of schizophrenia or schizoaffective disorder;
3. Patients experienced prominent and persistent negative symptoms \[Scale for the Assessment of Negative Symptoms (SANS) score ≥3 or Positive and Negative Symptoms Scale (PANSS)- negative subscale score ≥20\] in past 6 months;
4. No clinically significant positive symptoms \[PANSS positive subscale score \<20\];
5. No clinically significant depressive symptoms \[Calgary Depression Scale for Schizophrenia (CDSS) score subscale \<12\];
6. Able to give consent.

Exclusion Criteria:

1. With current misuse of or dependence on illegal drugs or alcohol;
2. High Suicide risk;
3. History of epileptic seizures;
4. With severe brain trauma, injury or other neurological diseases;
5. Metal (implants) in the skull;
6. Pregnancy
Topical Tranexamic Acid (TXA) in Joint Arthroplasty

The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.

Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.

Exclusion Criteria:

* allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance \<30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin \<11g/dl in females and \< 12g/dl in males).
Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients

Objectives:

* Assess the prevalence and severity of depression and anxiety in underserved and minority women seen in the gynecologic oncology clinic at Lyndon Baines Johnson General Hospital.
* Assess the prevalence and severity of sexual dysfunction in this patient population.

The instruments used in this study will be completed at one timepoint, by those women who choose to participate, anonymously. The questionnaires will be preceded with a statement informing the patient that by completing the study questionnaires she is consenting to study participation. No patient names or medical record numbers will be documented.

When a patient checks in for her clinic appointment, she will receive a packet of study materials consisting of a cover letter describing the study objectives, the Female Sexual Function Index, the Hospital Anxiety and Depression Scale, and a demographic questionnaire. The tools used in this study will be available in both English and Spanish.

Eligibility Criteria:
Inclusion Criteria:

- Women seen at the Gynecologic Oncology Clinic at the Lyndon Baines Johnson General Hospital. The women must be able to read and write either English or Spanish.

Exclusion Criteria:

- Women who are unable to complete the questionnaires.
Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of MAM.

This is a prospective, randomised, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM. The setting will be 21 rural sites in southern Malawi. The participants will be 1800 children 6-59 months old with MAM, defined as mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm and/or a weight-for-height Z-score (WHZ) between -2 and -3 without bipedal edema. Children will receive approximately 75 kcal/kg/d (314 kJ/kg/d) of one of two RUSFs in two-week rations for outpatient therapy of MAM. The two supplements will be a novel, locally produced peanut/dairy RUSFs, one with a high protein quality (HIPRO RUSF) or one with a standard protein quality, referred to as control RUSF (C-RUSF). The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm and/or WHZ\>-2 by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default). Secondary outcome measures include rates of weight, height, and mid-upper-arm circumference (MUAC) gain, time to graduation, and adverse effects from the supplementary foods.


Eligibility Criteria:
Inclusion Criteria:

* MUAC \< 12.5 cm and ≥ 11.5 cm
* without bipedal edema

Exclusion Criteria:

* simultaneously involved in another research trial or supplemental feeding program
* developmentally delayed, have a chronic debilitating illness such as cerebral palsy
* history of peanut or milk allergy
Construction and Application of a Self-Care Behavior Intervention Scheme for Chronic Heart Failure Patients Based on Interaction Model of Client Health Behavior

The purpose of this study, which will last for 3 months, is to investigate the effect of the intervention based on the interaction model of health behavior on patients' disease perception, heart failure self-care level, quality of life and service satisfaction. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and care; The purpose of this study is to improve your level of self-care, prevent your readmission to the hospital, and do not harm your physical and mental health, nor negatively affect the patient's relationship with care; Your participation in the study and the personal data in the study are confidential, and any public report on the results of this study will not disclose your personal identity.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CHF according to the New York Heart Association (NYHA) functional classification of II-III.
* Age ≥ 18 years, stable condition, clear consciousness, normal language and written expression abilities, no communication barriers, able to understand and accurately complete questionnaires.
* Informed consent and voluntary participation.

Exclusion Criteria:

* -Patients with complications such as renal or hepatic insufficiency, a history of mental disorders, or currently experiencing mental disorders, or critically ill.
Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction

We will develop a procedure for conditioning cue-cocaine associations in human drug users. Next, we will reactivate that learning and intervene pharmacologically to prevent the reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and pharmacological approach will have significant potential for persistently inhibiting relapse.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 50 years
2. voluntary, written, informed consent
3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
5. recent street cocaine use in excess of that administered in the current study
6. intravenous and/or smoked (crack/freebase) use
7. positive urine toxicology screen for cocaine
8. for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (-HCG) test
9. able to read English and complete study evaluations.

Exclusion Criteria:

1. Other drug dependence (except nicotine)
2. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine
3. a history of significant medical (cardiovascular) or neurological illness (e.g., prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrythmias of clinical significance, and/or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures)
4. current use of psychotropic and/or potentially psychoactive prescription medication
5. seeking treatment for drug abuse/dependence
6. those having contraindications to beta-blocker administration, including diagnoses of asthma, bronchitis, emphysema, or a history of adverse reactions to beta-blockers (including propranolol), as well as those with bradycardia and/or first-degree or greater heart block by ECG
A Study to Assess Virtual Reality by Healthcare Providers: A Pilot Study

The purpose of this study is to evaluate the acceptability of using Virtual Reality intervention to help reduce anxiety and burnout symptoms and improve focus in the workplace.

The proposed investigation will apply two novel paradigms using proprietary Virtual Reality interventions designed to reduce anxiety and inattention. We will explore whether this intervention is safe and acceptable, and whether it can impact the stress, anxiety, and difficulty in focus of employees in the workplace. Participants will view two different nature videos in two different formats. Each video will be experienced through Virtual Reality or non- Virtual Reality.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at the time of consent.
* Healthcare Professional with the Mayo Clinic.
* Not pregnant by participant self-report at time of consent.
* Have the ability to provide informed consent.
* Have no contraindicated comorbid health conditions as determined by the clinical investigators.

Exclusion Criteria:

* Currently (within the past 3 weeks) practicing mindfulness training on a weekly/regular basis.
* Currently (within the past 3 weeks) undergoing an additional program (e.g., Complementary and Alternative Medicine \[CAM\]) to improve quality of life.
* Currently (within 3 weeks) enrolled in another clinical or research program (e.g., CAM) which impacts the patients' quality of life (QOL), stress or anxiety.
* Currently has photosensitivity.
* Cannot tolerate virtual reality experiences.
* An unstable medical or mental health condition as determined by the physician investigator (e.g., pre-existing eye strain, seizures, dizziness, nausea)
Potentiation of Procedural Motor Learning in Health and Disease

The investigators plan to improve the learning of motor skills by pharmacological means (dopamine), and by noninvasive brain stimulation. They will study both healthy subjects and chronic stroke patients. In addition, they want to study the mechanisms of enhanced learning, on the molecular and the systems level.

Adaptive behavior requires procedural motor learning, i.e. the acquisition of motor skills. Procedural learning is particularly critical in the rehabilitation of chronic motor deficits after stroke. A potent modulator of motor function and learning is found in the endogenous dopaminergic system. The investigator's own work could demonstrate that formation of an elementary motor memory, which constitutes the first step in acquiring more complex motor skills, can be enhanced in both healthy subjects and chronic stroke patients by pre-medication with levodopa. The aim of the present proposal is to:

* expand these exciting findings to procedural motor learning;
* explore the interaction with age, brain lesions, add-on interventions such as transcranial direct current stimulation (tDCS); and
* illuminate the underlying mechanisms.

The effect of levodopa +/- tDCS on procedural motor learning and cortical excitability will be studied in healthy volunteers and stroke patients. Then the investigator plans to delineate the underlying mechanisms of this effect by exploring N-methyl-D-asparate (NMDA) receptor-dependency of levodopa-enhanced learning and changes in activation and connectivity (using functional magnetic resonance imaging) in the respective neural networks resulting from the interaction of learning and dopaminergic neuromodulation.

Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers:

* Normal neurological examination
* Mini Mental State Examination of \> 27
* Right handedness

Stroke Patients:

* Cortical or subcortical stroke with an initial severe hemiparesis Medical Research Council (MRC) scale \< 2 that has recovered to a degree that patients are able to perform the proposed task (in general \> MRC 4.5, with low spasticity, work in progress on motor learning in stroke patients)
* At least 1 year post-stroke
* Mini Mental State Examination of \> 27
* Right-handedness

Exclusion Criteria:

Healthy Volunteers and Stroke Patients:

* No antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system.
A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis

In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.

To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any safety concerns. All investigators were verbally informed by the study team since November 8, 2011 to stop the subject recruitment as soon as possible. All 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.

Eligibility Criteria:
Inclusion Criteria:

* Presence of candidemia or invasive candidiasis.
* Presence of one or more of signs and symptoms of acute fungal infection.

Exclusion Criteria:

* Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled.
* Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.