cyrilzakka/clinical-trials huggingface dataset:
Manual Diaphragm Release on Stepping Reaction Time in Chronic Obstructive Pulmonary Disease

Finding the effect of diaphragm release exercises on stepping reaction time and balance in patients with chronic obstructive pulmonary disease patients.

Sixty patients with Chronic Obstructive Pulmonary Disease (COPD) will be randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be 55 years and above with history of COPD. The Ex group will attend 4 sessions/week of Manual Diaphragm Release Technique Combined with Deep Breathing (10:15-min) for 8 weeks, the CON will attend 4 sessions/week of Deep Breathing (10:15-min) for 8 weeks. The stepping reaction time will be assessed by the choice stepping reaction time (CSRT). The Balance will be determined using a Time up and Go test (TUG) an d Berg balance scale (BBS). All the outcomes will be examined at baseline, and 8 weeks of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* All participants with a history of COPD
* Adults ranging from 55- 70 years old of both genders.
* Medically stable

Exclusion Criteria:

* Obesity (BMI ≥ 30 kg/m2)
* History of Pneumonia
* Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm.
* History of Myocardial infarction and/or cardiothoracic surgery
* orthopedics, or neurological that may interfere the intervention.
* Visual impairments, vestibular disorders, and postural hypotension.
* Dementia that interferes with the ability to follow instructions.
Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery. Device images, safety results and surgeon questionnaire will demonstrate that the TrueVision system provides clear images to assist surgeons during LRI or capsulorhexis procedures.


Eligibility Criteria:
Inclusion Criteria:

* Healthy eye with no previous ocular surgery
* Natural lens for which phacoemulsification extraction and posterior IOL implantation is planned
* Clear intraocular media other than cataract
* Potential visual acuity 20/30 or better
* Able to comply with preop and postop examination procedures
* Signed and dated informed consent

Exclusion Criteria:

* Keratometric astigmatism \> 2.5 diopters
* Corneal pathology potentially affecting topography including corneal degeneration
* Irregular astigmatism
* Macular degeneration or any other macular disease which reduces potential acuity
* Previous corneal surgery (including LASIK, radial keratotomy, penetrating keratoplasty, etc)
* Use of systemic or ocular medications that affects vision
* Acute or chronic systemic or ocular disease or illness that would increase risk or confound study results
* Use of Flomax or any other medication which negatively impacts surgical outcomes
* History of ocular trauma or ocular surgery
Non-returning Catheter Valve for Reducing CAUTI

This study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients.

Non-returning catheter valve (generic name) used UnometerTM SafetiTM Plus (trade name)

Eligibility Criteria:
Inclusion Criteria:

* The participants who age more than 18 year and admitted to the medical intensive care unit or intermediate care unit
* All participants must be retained the urinary catheter.

Exclusion Criteria:

* The participants were diagnosed urinary tract infection before retention of the urinary catheter.
Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia

This study will be a single center, open-label study of a single concentration of ANR- 001.1. The solution will be applied to the scalp of 14 male subjects by study staff once daily for 7 days.

At screening, subjects will sign informed consent and inclusion and exclusion will be reviewed for each subject. Screening data will include demographics, medical history, concomitant medications, physical examination, weight, O2 sat, vital signs laboratory evaluation (CMP, CBC, UA), and ECG.

At Day 1, a physical exam, weight, O2 sat, vital signs (including BP, pulse, respiratory rate and temperature) and review of concomitant medications will be performed, and admission criteria reviewed.

If criteria are met, the study staff will administer the first dose of study medication to the area of hair loss on the scalp (8 cm x 6 cm). If there is no hair loss the dose will be administered to the crown of the head (8 cm x 6 cm). The study staff will continue to administer the study medication to the same area of the scalp of the subject, once daily for Study Days 1, 2, 3, 4, 5, 6, and 7. Daily subject visits will include vital signs, review of adverse events and concomitant medications. PK draws and ECGs will take place at Study Days 1, 2, 7 and 8, following the first dose and the last doses, respectively.

Eligibility Criteria:
Inclusion Criteria:

Males between age 18 to 65 years, in general good health. Good health is defined as a subject without any active diseases. Not included in active diseases are:

* Migraines
* Non-hospitalized depression o Asthma
* Cholecystectomy
* Gilbert's syndrome

  * Clinical diagnosis of AGA with grade II to VI hair loss on Norwood Hamilton Classification System
  * Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator's opinion, interfere with study assessments.
  * No known allergy to ANR-001.1 or any of its components.
  * Subject is willing to avoid extensive sun exposure, phototherapy, or use of tanning salon for the duration of the study.

Exclusion Criteria:

If subjects have a BMI outside of the range of 18-35kg/m2

* Subjects using a minoxidil product (e.g., Rogaine or generic Rogaine) or a latanoprost product (e.g., Xalatan or generic Xalatan) within 30 days of the start of Day 1 of the study.
* Subjects whose vital signs, ECG, safety labs or physical exam results are clinically significant in the opinion of the investigator.
* Subjects have a skin condition that, in the Investigators opinion, could interfere with study assessment or put the subject at undue risk by study participation.
* Subjects with an active or recent (within 30 days before Day 1) disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.).
* Subjects with known or suspected hypersensitivity or allergic reaction to any of the active or inactive components of the test treatment.
* Current enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)


Eligibility Criteria:
Inclusion Criteria:

* Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root.
* Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less.
* Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy
* Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment.

Exclusion Criteria:

* Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
* Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine.
* Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization.
* Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization.
* Subjects with a body mass index (BMI) ≥40.
* Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.
Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma

The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph node for those patients. Recently, more and more studies had found the incidence of lymph node metastasis was higher in autopsy specimen than those in operable patients.

This project is a prospective randomized controlled trial, planning to compare hepatectomy with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC patients, to reach a further understanding of the role of lymphadenectomy.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years;
* Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
* good liver function with Pugh-Child Class A or B;
* indocyanine green retention at 15 minutes (ICG-R15) \<15%;
* without severe cirrhosis;
* the diameter of tumor is equal to or more than 3 cm;
* the liver resection could be assessed R0 (the define of R0 resection will be explained in the section of Surgical procedures);
* absence of extrahepatic metastasis.

Exclusion Criteria:

* the diameter of tumor is less than 3 cm;
* palliative resection of tumor;
* with the history of hepatic encephalopathy, ascites, and variceal bleeding;
* with severe hepatic cirrhosis;
* tumor rupture;
* with the history of upper abdominal surgery, it is tough to remove the regional lymph nodes; or it is unable to be resected when multiple lymph nodes mixed and fixed.
Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study

Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI.

Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Eligibility Criteria:
Main Inclusion Criteria:

* Age 21-80 years
* First myocardial infarction
* Acute anterior STEMI with ≥ 2 mm in 2 or more contiguous anterior leads or≥ 4 mm total ST-segment deviation sum in the anterior leads
* Signed Informed Consent

Main Exclusion Criteria:

* Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than 2.5mmol/L
* Inferior STEMI or suspected right ventricular failure
* Suspected or known pregnancy
* Suspected active infection
* History or known hepatic insufficiency prior to catheterization
* On dialysis therapy
* Known contraindication to:
* Undergoing MRI or use of gadolinium
* Heparin, pork, pork products or contrast media
* Receiving a drug-eluting stent
* Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device
Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Eligibility Criteria:
Inclusion Criteria:

* Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes

Exclusion Criteria:

* Hypersensitivity to ziprasidone
* prolonged QTc interval
* coadministration with substances that are prolonging the QTc interval
* recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments
The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients

The goal of this clinical trial is to compare the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients undergoing surgery. The main questions it aims to answer are:

* \[Is the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients different?\]
* \[Is the incidence of postoperative cognitive dysfunction between the intravenous anesthesia group and the inhalation gas anesthesia group different?\] Participants will be anesthetized with different categories of anesthetics.

  * Intravenous anesthetics
  * Inhalation gas anesthetics

This clinical trial targets patients aged 60 years or older with American Society of Anesthesiologists physical status (ASA) 1 to 3 who undergo surgery under general anesthesia at our hospital. Before entering the operating room, patients are randomly assigned to the intravenous anesthesia group and the inhalation gas anesthesia group. The intravenous anesthesia group uses propofol for anesthesia, and the inhalation gas anesthesia group uses sevoflurane. A 3 mL blood sample is collected four times: before surgery, at the end of surgery, 4 hours after surgery, and 1st day after surgery. All blood samples will be immediately transferred to the department of Laboratory medicine and stored at -80 degree. Pre-scheduled tests to determine the brain-blood barrier permeability and inflammatory cytokines will be conducted after the recruitment of all samples. In addition, for patients scheduled to be transferred to the intensive care unit (ICU) after surgery among the study subjects, a 3 mL of cerebrospinal fluid sample is collected two times: before surgery, and at the end of surgery. The same preservation protocol will be applied to the cerebrospinal fluid samples. All study subjects will be monitored for postoperative delirium daily for up to 7 days after surgery or until discharge. Cognitive function is assessed using telephone version of the Montreal Cognitive Assessment (T-MOCA) before surgery and 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* age equal to or older than 60
* american Society of Anesthesiologists (ASA) grade I to III
* general anesthesia longer than 2 hours

Exclusion Criteria:

* history of dementia
* history of schizophrenia, epilepsy, or Parkinson's disease
* history of stroke or craniectomy
* patient denial
Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 against placebo following third molar extraction.


Eligibility Criteria:
Inclusion Criteria:

* Oral surgery having removed 2 unilateral third molar teeth.
* Pre-dose pain intensity score (100 mm VAS \[VAS\]) of at least 50mm within 5 hours of oral surgery
* Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery

Exclusion Criteria:

* Presence or known history of any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic (including known drug hypersensitivities or allergies, but excluding untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase risk associated with study participation, investigational drug administration or may interfere with interpretation of study results.
* Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
* Active dental infection at the time of surgery.
* Recent (within the previous 12 months) history of chronic analgesic or tranquiliser dependency.
* Any significant oral surgery complication at the time of surgery or in the immediate postoperative period, or oral surgery that has lasted more than 30 minutes (time from first incision to last suture placement).

Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.
Evaluation of the Compress Distal Femoral Replacement System

Patients in this study require a replacement of a lower thighbone and knee joint. A new device, called the ComPreSs, will be used in this study to replace the lower thighbone. This new device has not yet been approved by the Food and Drug Administration (FDA). There is not enough data to assure that it is as good as other devices currently available. Taking part in this study will help provide data to the FDA. Other devices used to replace large pieces of bone and joints in the leg can result in damage to the bone over time. The bone damage can cause the device to come loose from the bone. This is a bad problem, and causes pain, and often more surgery is needed. This new device connects to the bone in a different way to prevent some of the problems seen with other devices. The new device protects the bone, and may help the replacement last longer. So far, the device has been used in over 50 patients on a selective basis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bone tumors of the distal femur requiring primary bone resection of up to 30 cm with the resection at or below the lesser trochanter.
* Patients with prior orthopaedic oncologic conditions requiring revisions of distal femoral replacement devices with a total replacement height of 30 cm or less and the resection level is at or below the lesser trochanter.
* Patients who have a cortical bone thickness of 2.5 mm or larger in the region where the ComPreSs device would be implanted.
* Patients diagnosed with a bone tumor classified as Stage 1A, IB, IIA, IIB, or III by Enneking's classification system. (See section 12.0, #7)

Exclusion Criteria:

* Patients with active infection.
* Patients who are unable to return for follow-up examinations.
* Patients who have cortical bone thickness less than 2.5 mm in the region where the ComPreSs device would be implanted.
* Patients who are unwilling or incapable of following postoperative care instructions.
* Patients requiring bilateral knee implants.
* Patients with evidence of vascular insufficiency (arterial and/or venous).
* Patients having Parkinson's disease, severe muscular atrophy, neuromuscular disease in the affected limb.
* Patients with prior irradiated bone.
* Patients with metastatic cancer including carcinoma, melanoma, myeloma, lymphoma, leukemia.
* Patients with pathologic soft tissue or skeletal conditions that would prevent secure fixation of the device in the bone.
A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors

The purpose of this study is to evaluate the safety and effectiveness of Nivolumab in combination with Ipilimumab in Chinese participants with previously treated late stage cancer.


Eligibility Criteria:
Inclusion Criteria:

* Mainland Chinese participants with advanced or recurrent solid tumors
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* One prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy

Exclusion Criteria:

* Cancer that has spread to the brain or central nervous system unless it has been adequately treated . In addition, either no longer receiving corticosteroids, or on a stable or decreasing dose of no more than 10 mg daily prednisone (or equivalent)
* Active, known or suspected autoimmune disease or infection
* Positive blood screen for chronic infection of hepatitis B or hepatitis C (HCV antibody positive unless HCV RNA is negative)
* Prior immuno-oncology therapy

Other protocol-defined inclusion/exclusion criteria apply
Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension

This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to continue treatment with oral levosimendan. The study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with ALS.

This is an open-label study, so that all eligible subjects that complete the double-blind REFALS study (48-weeks of treatment) will have the opportunity to receive oral levosimendan treatment. The primary objective, in addition to continuing treatment for subjects enrolled in the REFALS study, is to evaluate long-term safety of oral levosimendan in ALS patients. Another important objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with ALS.

This study is open only to patients taking part in the REFALS study.


Eligibility Criteria:
Inclusion Criteria:

* Written or verbal informed consent (IC) for participation in the study
* Subjects who completed 48 weeks of treatment according to the REFALS study protocol
* Able to swallow study treatment capsules at the time of completing 48 weeks dosing in the REFALS study

Exclusion Criteria:

* Development (or significant worsening from baseline of the REFALS study) of serious cardiovascular disease (e.g.: myocardial infarction, heart failure, arrhythmia, stroke, or second or third degree atrioventricular (AV) block)
* Pulse/heart rate repeatedly \>100 bpm after 5-minute rest at baseline. If the pulse/heart rate is \>100 bpm in the first recording, then a second recording must be done after another 5 min rest to confirm pulse/heart rate \>100 bpm
* Systolic blood pressure (SBP) \<90 mmHg
* Severe renal impairment (creatinine clearance \< 30ml/min or creatine \>170 µmol/l at 48 week visit of the REFALS study, or on dialysis
* Severe hepatic impairment at the discretion of the investigator
* Women of reproductive age without a negative pregnancy test and without a commitment to using a highly effective method of contraception (e.g.: oral hormonal contraceptive associated with inhibition of ovulation, intrauterine devices and long acting progestin agent), if sexually active during the study, and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included
* Subject judged to be actively suicidal by the investigator
* Any other clinical significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study