cyrilzakka/clinical-trials huggingface dataset:
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.


Eligibility Criteria:
Inclusion Criteria:

• Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)

Exclusion Criteria:

* medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
* Substantial alcohol or drug abuse.
* History of narcotics within 6 months of surgery.
* Pregnancy.
* Renal impairment.
* Peptic ulcer disease.
* GI bleeding.
Rural Access to Physical Therapy for Osteoarthritis Rehabilitation - Pilot

This is a pilot study involving a hybrid in-person + telerehabilitation intervention for rural adults with knee osteoarthritis. The primary purpose is to demonstrate feasibility and safety of the RAPTOR program, and the secondary purpose is to estimate clinical effectiveness of the RAPTOR program on participants' pain, function, and quality of life.

The purpose of the RAPTOR pilot study is to determine feasibility of a rural telerehabilitation intervention by assessing (1) attendance rate for telerehabilitation visits among participants in the pilot program; (2) participants satisfaction with the program; and (3) participant outcomes regarding pain, function, and quality of life. This pilot study will provide preliminary data to support efforts to obtain external funding for a future randomized trial comparing traditional physical therapy (PT) to the RAPTOR approach.

The primary purpose of the RAPTOR pilot study is to demonstrate feasibility and safety of the RAPTOR program in rural adults with knee osteoarthritis (KOA). The secondary purpose is to estimate clinical effectiveness of the RAPTOR program on participants' pain, function, and health-related quality of life. This will enable the investigators to determine a sample size estimate for a future trial comparing RAPTOR to a traditional face-to-face physical therapy approach in this population.

Specific Aim 1: To assess feasibility of the Rural Access to Physical Therapy for Osteoarthritis Rehabilitation (RAPTOR) program in delivering a hybrid telerehabilitation program to rural people with KOA.

Hypothesis 1: Participants in the RAPTOR program will attend at least 80% of study-related in-person and telerehabilitation visits, and will experience no serious adverse events.

Specific Aim 2: To determine preliminary clinical effectiveness of the RAPTOR program by assessing pain, physical function, and health-related quality of life via patient-reported and performance-based outcomes.

Hypothesis 2: A majority of RAPTOR participants will demonstrate clinically meaningful improvement in patient-reported pain, physical function, and/or health-related quality of life.

Eligibility Criteria:
Potential participants who meet all of the following criteria will be included:

* Participant meets American College of Rheumatology criteria for the clinical diagnosis of knee osteoarthritis
* Participant's home address is in a rural (non-core) western Pennsylvania county
* Participant is willing to travel to Centers for Rehab Services - Bedford clinic for two face-to-face sessions with a licensed physical therapist
* Participant has access to high-speed internet and/or LTE wireless service and a device (tablet, computer, or smartphone) to access the telerehabilitation platform
* Participant is aged 40 or over

Potential participants will be excluded if any of the following criteria apply:

* Chronic neurological disorder affecting balance or coordination
* Any other disorder that affects balance or gait
* Two or more falls in the past 12 months, OR sought medical attention for any fall within the past 12 months
Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin

The purpose of this study is to determine whether panax notoginseng saponins are effective in the treatment of Hypertensive Intracerebral Hemorrhage Patients.

Patients with HICH were randomly assigned to receive either PNS integrated with conventional therapy. Patients were treated with conventional therapy for 3 days, then plus PNS for 14 days. Patients in the control group received conventional therapy for 17days. Hematoma volume measured by CT scanning, National Institutes of Health Stroke Scale (NIHSS) scores, Barthel index (BI), all the three were used to evaluate the therapeutic effect for both groups after two weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

* with a history of hypertension treated with medication and blood pressure management ( a systolic blood-pressure target of 140 to 179 mmHg and a diastolic blood-pressure target of 70 to 100 mmHg) during the period of hospitalization,
* the site of hematoma located in one of the cerebral hemispheres,
* hematoma volume 10-30ml,
* no blood in the ventricles,
* within 24 hours of onset of first-time acute intracerebral hemorrhage,
* no loss of consciousness (drowsiness acceptable).

Exclusion Criteria:

* cerebellar or brainstem hemorrhage,
* intracerebral hemorrhage caused by bleeding diathesis, aneurysms, vascular malformations, improperly using anticoagulant drugs, or suspicious amyloid angiopathy,
* subarachnoid hemorrhage; multifocal hemorrhage,
* mixed stroke or hemorrhagic infarct,
* coexisting systematic diseases such as heart or kidney failure, tumors, gastrointestinal hemorrhage and so on,
* pregnant or lactating women,
* a history of XUESAITONG injection anaphylaxis.
Transfusion in Adult Acute Myeloid Leukemia

Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.

Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.

Based on these data, we retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 15 years old
* Newly diagnosed AML or post myelodysplastic syndrome (MDS)

Exclusion Criteria:

* Patients with M3 AML of FAB classification (APL, Acute Promyelocytic Leukemia)
* World Health Organization (WHO) performance status \>2;
* Left ventricular systolic ejection fraction below the normal range
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Serum creatinine concentration \> 2x ULN (Upper Limit of Normal laboratory ranges),
* AST or ALT levels \> 2.0 x ULN, except if AML-related
Safety of NNC 0123-0000-0338 in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male subject
* Body mass index (BMI) between 18 and 28 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician
* Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician
The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB) patients who were previously considered to have "idiopathic" OAB. To date, most research on the relationship between OAB and the UM has focused on differentiating between the UM of a normal bladder and that of an OAB bladder. There is currently a paucity of data on the way that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB treatment focused on how management with solifenacin affected the UM, but no studies have evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding IOI's impact on the UM is particularly interesting because despite both anticholinergics and IOI exerting antimuscarinic affects on the bladder, IOI is often successful when anticholinergics are not. This raises the question of what other mechanisms of action IOI may have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in those select patients who suffer from OAB due to an altered UM. The primary objective of this study is therefore to determine the UM profiles of OAB patients before and after treatment with IOI.


Eligibility Criteria:
Inclusion Criteria:

- Women undergoing intradetrusor botox injection with botox 100 U

Exclusion Criteria:

* Current UTI
* History of recurrent UTI
* History of antibiotic exposure for any reason (including if response is "unknown")
* Antibiotic exposure for any reason other than post-procedure prophylaxis during the four-week follow-up period.
Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes
* Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
* Body mass index (BMI) maximum 40.0 kg/m\^2

Exclusion Criteria:

* History of drug or alcohol dependence
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Proliferative retinopathy
* Total daily insulin dose at least 1.80 IU/kg
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects

The purpose of this study is to investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18.5 to 30 kg/m2, inclusive.
* Subject has hematology, coagulation, serum chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.

Exclusion Criteria:

* Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
* Subject has any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312. Cholecystectomy is permitted if there are no postcholecystectomy gastrointestinal symptoms.
* Subject has clinically relevant abnormalities in clinical laboratory parameters.
Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children

The aim of the project is to evaluate whether therapy with leukotriene may be a valid therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally or more efficient than nasal steroid.

The aim of the project is to evaluate whether leukotriene is less, equally or more efficient than nasal steroid in children with adenotonsillar hypertrophy and with mild and moderate OSAS checking if leukotriene administrated for 24 weeks improves overnight oximetry, polysomnography and checking if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild (RDI 3- \<5) or moderate obstructive apneas (RDI 5-8) by overnight polysomnographic evaluation with 4 channels EEG
* Adenotonsillar hypertrophy Friedman score's II-III-IV°

Exclusion Criteria:

* Neuromuscular, gastrointestinal, neurological diseases and syndromes of malformations
* Use of leukotrienes and/or nasal and oral steroids in the 4 weeks preceding the initial sleep study
* Acute upper respiratory tract infections
* Adenotonsillectomy
18F-NaF PET in Detecting Metastatic Bone Lesion for Patients With Cancer.

18F ion is a positron emitting bone radiopharmaceuticals. The skeletal uptake of 18F relies on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone metabolic activity (8). It has good soft tissue clearance and high affinity of to the bone matrix. It is able to perform a highly sensitive whole-body screening for bone metastases using a high resolution PET scanner. Therefore, we conduct a prospective study to evaluate the accuracy and clinical value of 18F PET in staging bone metastases by

1. Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy;
2. Determining the clinical impact of PET results on subsequent patient management.

Skeletal metastases are the most common cause of morbidity and mortality in patients with malignancy, especially in patients with breast cancer, lung cancer, prostate cancer and head \& neck cancer. In patients with lung cancer, bone metastases are present in 20-30% of patient at initial diagnosis (1-2). Accuracy staging bone metastases can lead to modification of following treatment and evaluation of prognosis.

The planar whole-body 99mTc-methylene diphosphonate (MDP) radionuclide bone scintigraphy is the most widely used technique in detecting metastatic bone lesions at present. Abnormal tracer accumulation may occur at any skeletal site with an elevated rate of bone turnover. However, conventional planar bone scintigraphy was reported to be less sensitive than MRI in detecting spinal metastases (3-7).

18F ion is a positron emitting bone radiopharmaceuticals. The skeletal uptake of 18F relies on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone metabolic activity (8). It has good soft tissue clearance and high affinity of to the bone matrix. It is able to perform a highly sensitive whole-body screening for bone metastases using a high resolution PET scanner.

To the best of our knowledge, there are only limited studies evaluating the clinical utilization of 18F-NaF PET for detection of bone metastases (10-12). Therefore, we would like to conduct a prospective study to evaluate the accuracy and clinical value of 18F PET in staging bone metastases by

1. Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy;
2. Determining the clinical impact of PET results on subsequent patient management.

99mTc-MDP scintigraphy and 18F PET will be performed in 2 weeks for all patients. Interpretation of 99mTc-MDP scintigraphy and 18F PET will be performed following the criteria described by Crasnow et all (13). The accuracy of 99mTc-MDP scintigraphy and 18F PET detection of bone metastases for each patient will be determined by the histopathological results, MRI results, or other clinical evidences afterward.

Eligibility Criteria:
Inclusion Criteria:

* pathology proofed lung cancer and are referred to perform whole-body bone scintigraphies for staging metastatic bone diseases

Exclusion Criteria:

* patients whose age are below 18
* pregnant women
A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects

The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants, between 18 and 45 years of age, inclusive.
* Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive.
* Certified as healthy by a comprehensive clinical assessment.
* Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

* Any history or presence of clinically relevant medical status as per the protocol.
* Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Botulism Outbreak in Thailand (Episode II)

A second botulism outbreak in Northern Thailand was reported in 2006. 192 people were exposed to raw meat and the gut of deer, 83 suffered from diarrhea. Of these 5 developed respiratory failure, 1 impending respiratory failure.

We analysed the clinical findings and electrophysiologic findings in this second episode of large botulism outbreak in northern Thailand.

PRELIMINARY REPORT Northern Thailand's big botulism outbreak occurred again on 30 June 14, 2006, \[16.00pm\] affecting 83 from 192 people who exposed to raw dear meat and gut \[1 night preserved with ice pack of whole body of dear before disection and distribution \]. Of these, 3 developed respiratory failure, 1 developed impending respiratory failure, 83 of 192 whom developed fatique and diarrhea after ingestion of raw dear meat and gut on 26-30 June 2006. 3 patients were refered to 2 high facility hospitals for severe respiratory failure. Physical examination of 3 patients in ICU of Chiang Kum general hospital revealed ptosis \[3/3\] mild ophthalmoparesis \[2/3\] Proximal muscle weakness \[2/3\] abdominal paradoxical respiration \[3/3\] pupil dilate \[1/3\] and negative inspiratory pressure \[NIP\] less than 15 mmHg \[3/3\] were observed. Neurological electrophysiologic study of 2 patients revealed low amplitude compound muscle action potential \[CMAP\] of Abductor digiti minimi \[ADM\] muscle with decrement response after repetitive stimulation with low frequency \[3Hz\], increment response of ADM muscle after stimulation with high frequency \[10Hz, 20Hz, and 30Hz.\].The electrophysiologic findings support diagnosis of presynaptic neuromuscular dysfunction with respiratory failure, Botulism is most likely diagnosis. After treated with botulinum antitoxin \[on July,1 ,2006 \[mixed-type botulinum antitoxin --donated from Japan at Nan Hospital's botulisum outbreak on March 14,2006\], 3 patients in ICU showed improvement of over all clinical outcomes. Active survey by Ministry of Public Health of Thailand and CDC-USA to identify the high risk patient who may develop respiratory failure , and immunologucal vs microbiological diagnosis were performed. This outbreak may be the second hit of botulisum in the northern Thailand but less amount of severe cases was observed.

Eligibility Criteria:
Inclusion Criteria:

* Ate the deer meat and/or the gut from Chiang Kum district, after June 26,2006
* Clinical botulism or respiratory failure who need ventilator assistance
* The staff of referring hospital willing to participate in the Thai Botulism study group

Exclusion Criteria:

• Patients who did not eat deer meat and or the gut from Chiang Kum district
Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy

This study is based on previous observation that, in men with localized prostate cancer, non-cancerous prostate tissue is hypoxic, and on the known contribution of hypoxia to the progression of cancer. Patients undergoing diagnostic prostate biopsy with serum prostate specific antigen (PSA) less than 10ng/ml and who have given informed consent will have oxygen measurements of the prostate and peri-prostatic tissue taken with the Eppendorf electrode at the time of biopsy. The oxygenation of normal prostate tissue will be compared to that of cancerous prostate tissue. In men with negative biopsies, the prostate tissue oxygen measurements will be compared with the peri-prostatic tissue oxygen measurements.


Eligibility Criteria:
Inclusion Criteria:

* Men due to undergo sextant prostate biopsy
* Serum PSA \<10 ng/ml

Exclusion Criteria:

* Previous diagnosis of prostate cancer
* Inability to give informed consent