cyrilzakka/clinical-trials huggingface dataset:
Patient Feedback Effectiveness Study

The purpose of the study is to determine if a semi-automated quality improvement system that provides addiction counselors with feedback on their average treatment satisfaction and therapeutic alliance (as rated by patients currently in treatment) is superior to no feedback in 32 community-based outpatient addiction treatment clinics.

Quality improvement (Ql) methods are a cornerstone of business and healthcare management throughout the United States yet there have been few studies of Ql interventions in addiction treatment settings. The proposed study tests the effectiveness of one Ql system - Patient Feedback (PF) - at increasing outpatient group therapy attendance and self-reported abstinence. The feasibility and acceptability of PF was established in a six-site study conducted within the National Drug Abuse Treatment Clinical Trials Network. In the proposed study, 32 community-based outpatient treatment programs with approximately 250 clinicians will be randomly assigned to PF, or usual clinic practices. In the PF condition, every week fro 12 weeks clinic patients are invited to complete a 12-item, self-administered survey in which they rate therapeutic alliance and treatment satisfaction, and report past week substance use. These anonymous surveys are faxed by clinic staff to a University of Pennsylvania data center where a custom software application converts the surveys into feedback reports and posts them to a password protected website. Clinicians can access their caseload feedback reports and aggregated reports for the whole clinic; supervisors can only access the aggregated clinic reports. On a monthly basis staff meet as a team to review the feedback reports and develop Ql plans intended to yield improvements in select Ql indicators. The PF website and the monthly PF e-newsletter provide social recognition, clinical resources, and a virtual community for participating clinicians. After 12 weeks, participants in both conditions complete follow-up measures and then both groups are given open access to PF for 12 additional months. During "sustainability phase" staff usage of the PF website is monitored. Alternate versions of the PF Survey are introduced during the sustainability study, including one that monitors HIV risk behavior. The rapid processing of surveys enables near real time feedback to clinic staff. Organizations may share their feedback reports with funding sources, regulatory agencies, policy makers, and other stakeholders. This centralized, semi-automated feedback system eases fulfillment of accreditation requirements and as such, reduces the cost of clinic operations.

Eligibility Criteria:
Inclusion Criteria:

* program: adult, outpatient, non-methadone maintenance substance abuse treatment programs
* clinician: must be leading at least one weekly group with minimum of 5 patients
* must be working at least 20% time at facility

Exclusion Criteria:

* clinics with fewer than 5 clinicians who conduct weekly group counseling
* clinics in which fewer than 50% of clinicians agree to participate
GOREISAN for Heart Failure (GOREISAN-HF) Trial

The objective of the GOREISAN-HF trial is to assess the effect of the administration of Goreisan (TJ-17) plus standard therapy compared to standard therapy alone on the improvement rate of cardiac edema and clinical outcomes in worsening congestive heart failure with volume overload.

Current guidelines recommend the use of loop diuretics as an indication for class I to improve HF symptoms regardless of left ventricular ejection fraction. Loop diuretics, however, are known to activate the renin-angiotensin-aldosterone system and the sympathetic nervous system, which could accelerate HF progression. Loop diuretics could also cause worsening renal function and electrolyte disturbance, and it is desirable to have an alternative drug to loop diuretics to effectively relieve congestive symptoms. Goreisan (TJ-17), a traditional Japanese medicine composed of five herbal medicines, has long been used in Japan to treat impairments of the regulation of body fluid homeostasis, including edema, and has been less likely to cause renal dysfunction and electrolyte abnormalities. We therefore planned a multicenter, randomized, interventional, parallel assignment, open-label treatment trial to evaluate the long-term effect of in-hospital initiation of Goreisan, when added to standard therapy, in patients with worsening congestive heart failure and clear signs of volume overload.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed congestive heart failure (CHF) by Framingham criteria
* CHF patients with cardiac edema and signs due to cardiac edema (signs of fluid overload: lower limb edema, pulmonary effusion, or pulmonary congestion on chest x-ray)
* Elevated N-terminal pro brain-type natriuretic peptide (NT-proBNP) ≥300 pg/mL or brain natriuretic peptide (BNP) ≥100 pg/mL at enrollment
* Patients ≥ 20 years of age, male or female
* Provision of signed informed consent before any assessment is performed

Exclusion Criteria:

* Valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
* Implantation of a cardiac resynchronization therapy (CRT) within 12 weeks prior to enrollment or intent to implant a CRT device
* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
* End-stage renal failure (estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73m2) at enrollment
* Patients who are expected to have a life expectancy of 6 months or less
* Acute coronary syndrome at screening
* Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization
* Treatment with herbal medicine at enrollment
* Confirmed poor tolerability of Goreisan (including cinnamon allergy)
* Considered not appropriate for the participation of the study
Analgesic Effect of Erector Spinae Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy

* Thoracic incisions are painful and associated with chronic post-surgical pain and inadequate analgesia is associated with poorer postoperative outcomes. Recent progress has been made in the field of thoracic anesthesia by improving analgesic modalities such as PECS 1 and PECS 2, intercostal plane block, paravertebral regional anesthesia, ultrasound-guided erector spinae and serratus anterior plane block.
* Administered of the local anesthetic in erector spinae plane block is in the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces. It affects both the ventral and dorsal rami and leading to blockage of both visceral and somatic pain.
* Ultrasound-guided serratus anterior plane block is a facial plane block that provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle.
* We hypothesize that the ultrasound-guided erector spinae plane block may have better quality than the serratus anterior plane block for patients undergoing thoracoscopic sympathectomy as erector spinea plane blocks visceral and somatic pain.

Primary palmar hyperhidrosis (PPH) refers to the excessive secretion of exocrine glands on the palms, which is often accompanied by the head, face, or plantar hyperhidrosis. PPH demonstrates no obvious organic cause; however, some patients may feel distressed because their palms sweat more than normal, and such a situation may lead to severe psychological, social, and occupational dysfunction.

Endoscopic thoracic sympathectomy abolishes eccrine sweating in all areas supplied by the postganglionic fibers with its complications which include post-sympathetic neuralgia which is the most important, wound infection, hemorrhage, pneumothorax, horner syndrome, no response to the operation and compensatory hyperhidrosis in non-denervated areas.

Forero described ultrasound-guided erector spinae plane block for treatment of thoracic neuropathic pain and explained it as a peri-paravertebral regional anesthesia technique that has been used for prevention of postoperative pain in various surgeries.

Ultrasound-guided serratus anterior plane block is a facial plane block which provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by serratus anterior plane block

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists grade I or II physical status

Exclusion Criteria:

* Patients who had coagulopathies
* local infections
* neuropathies
* neuromuscular disease
* psychiatric disease
* history of thoracic surgery
* history of allergy to local anesthetics.
* receiving chronic analgesic therapy
* drug abusers
Study of Noni in Cancer Patients

The purpose of this Phase 1 study is to: 1. determine the maximum tolerated dose of capsules containing 500mg of freeze dried noni fruit extract, 2. define toxicities associated with the ingestion of noni, 3. collect preliminary information on the efficacy of noni in respect to anti-tumor and symptom control properties to help select specific patients for subsequent Phase 2 studies, 4. identify chemical constituents of the extract that can be used to characterize the bioavailability and pharmacokinetics of noni food supplement.

This Phase I study of noni in cancer patients represents a first step in the systematic study of Complementary and Alternative Medicine (CAM) practices that draw on Asian and Pacific Island cultural traditions of healing to control cancer and its related symptoms. Noni, extracted from Morinda citifolia or the Indian mulberry plant, is included in the traditional pharmacopoeias of Native Hawaiians, other Pacific Islanders and Asian populations, and has been used to treat various diseases for hundreds of years. It is now commonly taken by cancer patients based on purported usefulness in the disease although there is little scientific evidence to either support or refute these claims. A large marketing enterprise and at least eleven different suppliers supports the food supplement's popularity. The broad long range objectives which this study will initiate are to define the usefulness of noni extracts for cancer patients. The hypothesis to be tested is that noni at a specified dosing provides cancer patients with a sufficient benefit to toxicity profile to be useful as a therapeutic. Specific aims of this study are: 1. Determine the maximum tolerated dose of capsules containing 500mg of freeze-dried noni fruit extract. 2. Define toxicities associated with the ingestion of noni. 3. Collect preliminary information on the efficacy of noni in respect to anti-tumor and symptom control properties to help select specific patients for subsequent Phase II studies. 4. Identify chemical constituents of the extract that can be used to characterize the bioavailability and pharmacokinetics of noni food supplement.

Eligibility Criteria:
Patients must:

* Have a pathologically or cytologically verified diagnosis of cancer and evidence of disease for which no standard treatment is available;
* Be ambulatory, capable of self care, and up and about more than 50% of waking hours;
* Have completed all other cancer treatments at least four weeks previously;
* Have been on any medications considered by their physician to be essential to their health (e.g. lipid lowering, antidiabetic , antihypertensive) at consistent dosing at least four weeks prior to starting noni;
* Agree to take no other CAM treatments while taking noni and agree to keep a diary, recording all medications taken daily, including all non prescription products and to record the time that noni is taken.
Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18, under 75 years of age
* Patients Acute and Chronic Bronchitis

Exclusion Criteria:

* Patients who have gotten a glucocorticoids treatment within 4 weeks.
* Patients who need treatments of antibiotic and acute bronchitis infection.
* Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days.
* Bronchial asthma patient.
* Patients who have an indication of bleeding.
* Patients who have a serious heart and renal disease or liver ailment or immunosuppressive response.
* Patients who have history of over 3 phage of Chronic obstructiv lung disease
* Bronchiectasis patients.
Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery

The patients who are diagnosed with idiopathic epiretinal membrane and scheduled to undergo epiretinal membrane removal will be treated with conventional vitrectomy and the epiretinal membrane will be removed. After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or older than 19 years
* Patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery

Exclusion Criteria:

* Accompanied with retinal vascular disease or intraocular inflammation
* Prior treatment with vitrectomy in the study eye
* History of glaucoma
Microcirculation & ASICs

Pressure ulcers are a common and costly problem. Advancing the understanding regarding the basic pathophysiological mechanisms mediating the development of pressure ulcers will allow for better delineation of populations at risk.

Healthy skin is protected from pressure-induced ischemic damage because of the presence of pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous ischemia, which could lead to pressure ulcer formation.

Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments that block ASICs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or females aged between 18 and 40 years of age

Exclusion Criteria:

* no consent, diabetes, neuropathy.
Anti-Müllerian Hormone and Embryo Aneuploidy

The goal of this observational study is to determine is there an association between the rates of aneuploidy and the different ranges of serum Antimullerian hormone (AMH) levels.

Retrospective, single-centre study of patients undergoing IVF and preimplantation genetic testing with aneuploidy at the blastocyst stage between January 2018 and December 2022.


Eligibility Criteria:
Inclusion Criteria:

* All started cycles planned to be followed by preimplantation genetic testing for aneuploidies (PGT-A). PGT-A is proposed to the couples for the following reasons: advanced maternal age, recurrent miscarriage, repeated implantation failure or severe male infertility factor; it is also offered to all patients with a good prognosis who desired information regarding the ploidy status of their embryos.

Exclusion Criteria:

* Data from oocyte donation cycles
Acute Effects of Cryotherapy on Muscle Properties

The main aim of this study is to investigate the acute effects of cryotherapy on muscle mechanical properties, muscle strength, and activation changes in healthy subjects.

What changes occur in muscle stiffness following cryotherapy application? How does cryotherapy affect muscle strength? How does cryotherapy impact muscle activation? Are there differences in muscle mechanical properties, muscle strength, and muscle activation between different cryotherapy methods (ice massage and cold spray)? How do the effects of cryotherapy on muscle mechanical properties, muscle strength, and muscle activation change over time?

Eligibility Criteria:
Inclusion Criteria:

* Being willing to participate in the study
* Being between the ages of 18 and 35

Exclusion Criteria:

* Having undergone orthopedic surgery involving the lower extremity
An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment

The purpose of this study is to assess the association of retinal detachment (separation of the retina \[the innermost layer of the eyeball\] from its connection at the back of the eye) with exposure to oral ciprofloxacin or oral fluoroquinolones.

This is an observational (in which the investigators observe the outcomes of the study participants but do not intervene by, e.g, assigning the treatments) and retrospective (a study in which the exposures and outcomes occurred before the study began) study. It will use data from the Optuminsight and Truven Commercial Claims and Encounters databases, each of which will be evaluated separately using 3 designs: (1) Case-control (a design that compares the cases \[study participants\], ie, those with retinal detachment to controls, ie, a sample of similar people who did not have a retinal detachment) to assess whether their exposures to fluoroquinolones (FQs) differed. Two case-control studies are planned, one (replication) that mimics a previously reported study, the other (revised) that addresses more potential confounders than did that study , (2) Cohort (a design that follows the participants exposed to FQs and those not exposed to FQs to assess whether the two groups had different risks of developing retinal detachment), (3) Case-only (a design where the exposure history of individuals who had retinal detachment are examined to assess whether they were more likely to have had it when they were exposed to FQs than when they were not).

Eligibility Criteria:
Inclusion criteria:

* At least 1 year of enrollment in the study for medical and pharmacy benefits after their cohort (group) entry (the day of their first ophthalmologist visit) for case-control design
* Oral fluoroquinolone like levofloxacin or ciprofloxacin must be dispensed to participants for cohort design
* At least one visit to an ophthalmologist and enrolled at least for 1 year in the study for medical and pharmacy benefits prior to the date of first occurrence of the exposure of levofloxacin or ciprofloxacin for cohort design
* At least one visit to an ophthalmologist and enrolled at least for 1 year in the study for medical and pharmacy benefits prior to the diagnosis of their first retinal detachment (separation of the retina \[the innermost layer of the eyeball\] from its connection at the back of the eye) for case-only design

Exclusion criteria:

- Prior diagnosis of retinal detachment , prior diagnosis or procedure for inflammatory conditions of the eyeball, or hospital admission between cohort entry and the date of the retinal detachment
Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism

Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered intravenously (IV) in a series of 4 infusions every 3 months over the course of one year is safe and will induce a therapeutic effect in autism patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Ages 6 to 16
* Diagnostic and Statistical Manual of Mental Disorders (DSM IV) diagnosis of autism confirmed by Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised (ADI-R)
* No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
* No additional biomedical treatments started 6 weeks prior to enrollment
* No changes in dietary management for 3 months prior to enrollment
* Ambulatory or require minimum support walking, per parent
* Able to sit still for 5 minutes or longer with a preferred toy item, per parent
* Adequate vision and hearing for the purposes of test administration, per parent
* Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent
* Stable and controlled mental disorder
* Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures
* Normal heavy metals test for lead and mercury levels performed within 30 days of first stem cell infusion
* Must provide name and specialty of specialist who has made Autism Spectrum Disorder (ASD) diagnosis
* Adequate financial means to cover $7,200 (US Dollars) plus travel expenses

Exclusion Criteria:

* Significant prematurity at birth (less than 32 weeks gestation); or birth weight significantly below normal for gestational age (SGA - small for gestational age)
* mental retardation
* seizure disorder
* auto-immune conditions
* history of head trauma and other neurological or medical conditions
* Abnormal heavy metals test for lead and mercury performed within 30 days of first stem cell infusion
* Prior stem cell therapy of any kind
Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers

The objective of this research is to check whether the test drug (lamivudine in the form of coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres under fasting condition.

It is an open, randomized, crossover 2x2, single dose, with the administration of medicine with 28 healthy volunteers, adults aged 18-50 years, of both genders (14 males and 14 females). Of the 28 volunteers planned in the study protocol to start, gave up one (woman) before the start of Phase I. So the study was initiated and completed with the participation of 27 volunteers. The volunteers were in hospital for a period of approximately 36 hours in each stage.

Eligibility Criteria:
Inclusion Criteria:

* Considered healthy after undergoing a clinical evaluation;
* Agree freely and sign the Recruitment and Informed Consent Term, after all the content of the protocol was clear before any procedure;
* Present the body mass index greater than 19 and less than 30.

Exclusion Criteria:

* Results of laboratory tests outside the range considered normal, unless they were considered clinically irrelevant;
* Allergic to lamivudine or any other drug;
* Positive outcome of the pre-admission pregnancy test;
* Regular medication within four (4) weeks prior to the start of the study or use of any medication to present interaction with lamivudine one week before the start of the study;
* Use abusive alcoholic beverage;
* Use of illicit drugs and tobacco;
* History of liver disease, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric; hypo- or hypertension of any cause that required pharmacological treatment; myocardial infarction, angina and / or heart failure;