cyrilzakka/clinical-trials huggingface dataset:
COMPARATIVE STUDY OF THE EFFICACY OF HYALURONIC ACID, DRY NEEDLING AND COMBINED TREATMENT IN PATELLAR OSTEOARTHRITIS

Randomized clinical trial in patients with knee osteoarthritis. Sixty patients will be evaluated, divided in three groups (20 in each). One group A will be treated by dry needling in the vast internal, other group B will be treated with a standardized treatment protocol (electrotherapy and manual therapy), and group C will be treated with hialuronic acid. The investigators want to observe which technique is the most effective in osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with knee pain and diagnosed of osteoarthritis knee and confirm RNM
* More 18 years.
* Less 55 years

Exclusion Criteria:

* More 55 years.
* Less 18 years.
* mental dysfunction
* those who have any type of complication that can cause myofascial or neuropathic pain in the lower limb, such as lumbo-sacral radiculopathy, neuropraxia, neurothymesis, axonotmesis, or meralgia paraesthetica; who have any condition generally considered to be a factor in perpetuating TrPs, such as fibromyalgia, hypothyroidism, or iron deficiency; and patients who may have a fear of needles (belonephobia) will be excluded.

Patients with lower limb dysmetries of 0.50 cm or more were also excluded from this study.
Chemoreflex Gain on Exercise

The purpose of this study is to assess chemoreflex gain on exercise.

Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. The change in breathing that results from a change in the blood's CO2 concentration is called the chemoreflex.

In heart failure, a condition where the heart muscle is damaged and can not pump as well, this reflex is exaggerated. The result of this can be breathing conditions characterised by patients hyperventilating at times and at other times taking very shallow breaths or even stopping altogether. In the past the only way of measuring this chemoreflex was to get patients to breathe into a large container and to rebreathe their exhaled air and allow the CO2 to rise over time, whilst keeping the oxygen constant. The proportion by which the ventilation increases with increasing carbon dioxide is the chemoreflex gain. Unfortunately, because this test takes a long time to conduct, requires specialist knowledge and equipment it has not been possible to measure this reflex on exercise.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers: Males aged 18-80 years who are able to perform both running and cycling and can follow simple visual instructions.
* Heart Failure Subjects: Males aged 18-80 with a clinical diagnosis of heart failure who are able to perform both running and cycling and can follow simple visual instructions.

Exclusion Criteria:

* Chest pain of any cause within 4-6 days,
* Pulmonary oedema,
* Uncontrolled hypertension (systolic blood pressure \> 220 mm Hg, diastolic \>120 mm Hg),
* Severe aortic stenosis,
* Severe hypertrophic obstructive cardiomyopathy,
* Untreated life threatening arrhythmia,
* Dissecting aneurysm,
* Recent surgery (within 4-6 weeks), COPD.
Treatment Adherence in Substance Users

This study evaluates the factors associated with treatment adherence in substance users. Differences in the level of adherence to treatment according to patient-related factors, addiction and treatment are analyzed. The individual effect of each factor on treatment adherence is assessed.

INTRODUCTION: Treatment dropout is an unsolved problem in the addiction process which makes frequent the failure of the addiction therapy. Research shows that the majority of dropouts occur during the first weeks of the treatment. These are the most serious ones because they have the worst prognosis. Some factors, related to the patients and the therapy, have been associated with treatment dropout but the diversity of studied variables, the heterogeneity of patients and the sparse population of many studies, hampers external validity and comparison of results.

OBJECTIVES: Analyze the treatment adherence of an outpatient treatment program for addicts. Identify factors associated with treatment adherence in substance users.

MATERIAL AND METHODS: Observational, analytical, longitudinal and retrospective study in substance users who completed addiction treatment between November 2013 and January 2016. Treatment adherence is measured in terms of medical discharge, regular attendance at activities and success in the NOC indicators. Differences in the level of adherence to treatment according to patient-related factors, addiction and treatment are analyzed. The individual effect of each factor on treatment adherence is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Substance-Related Disorders
* Treatment for drug dependency

Exclusion Criteria:

* Admission for detoxification treatment.
Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement

Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes.

The aim of this study is to analyze the value (knee function, pain, and quality of life) of continuous passive motion (CPM) after total knee replacement (TKR), when it partially replaces group physiotherapy (PT) in inpatient rehabilitation to save human resources. Patients are randomized to CPM group, consisting of 3 daily sessions of 20 minutes each, or to group PT, consisting of 25 minutes physiotherapy in groups 5 days weekly. Multimodal rehabilitation does not differ for both groups throughout the 3-week rehabilitation stay.

Primary outcome is the Staffelstein Score, German standard score in rehabilitation. Secondary outcomes are Oxford Knee Score (OKS), active and passive range of motion (ROM), and pain on visual analogue scale (VAS). Return to work is assessed by post-operative days.

Eligibility Criteria:
Inclusion Criteria:

* Total knee arthroplasty because of knee osteoarthritis
* Inpatient rehabilitation in participating clinics

Exclusion Criteria:

* Pregnancy
* Not able to give informed consent
* Psychological disorders
* Body weight \&gt; 150 kg
* Hip range of motion \&lt; 50°
Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)

The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated. The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.

Following Screening, eligible participants will enroll in a Run-in Period. Participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender.

Baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the Randomization Visit (Visit 3). Following randomization, participants will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet.

Participants will have scheduled visits after the Randomization Visit at 2 to 4 week intervals. Each participant will be encouraged to adhere to medication and dietary instructions.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age, of either sex, and of any race.
* Obese or overweight participants.

Exclusion Criteria:

* Participants who have a history of major eating disorders, gastrointestinal (GI) surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectious, GI, hepatic, renal, hematologic, immunologic or psychiatric disease or diabetes.
Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

This study design is subject to relevant SFDA regulations about clinical trials. Patients will be screened for inclusion into the study at the initial visit(240 patients to be recruited) and then undergo a minimum of 3-7 day's placebo washout period(placebo wash out is to eliminate the effect of prior antipsychotic medication with tablets without any active ingredients)(patients without prior antipsychotic medication are exempt from the washout phase). After screening and washout period, eligible patients will be randomly assigned to the two treatment group, Aripiprazole or Risperidone, for 6 week's treatment. Patients will be hospitalized for the entire duration of the study. Patients' condition will be assessed weekly.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for screening

1. Schizophrenia or Acute schizophrenia-like psychotic disorder(ICD 10)
2. PANSS total of no less than 60
3. Age: 18-65; male or female
4. Informed consent from the legal guardians of the patients Inclusion criteria after washout

1.PANSS total of no less than 60 2.3-7days washout with placebo is required after discontinuation of other oral antipsychotics; No washout is needed for patients who had never taken any antipsychotics before; In cases that patients's condition is deemed clinically deteriorating and immediate treatment is needed, patients with less than 3 days' placebo washout could be randomized after notifying the sponsor 3.No serious function impairment in heart, liver or kidney.

-

Exclusion Criteria:

For screening

1. Tendency or history of suicide
2. Patients with extreme agitation, violent attacking behavior towards people and those who can hardly comply with treatment
3. Diagnosis of other mental diseases besides Schizophrenia
4. Diabetes or other serious unstable diseases or the following neurological diseases, migraine, epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and TIA etc
5. Patients who take Fluoxetine in the past 1-month before screening
6. Patients who had participated any other clinical trial in the past 1-month before screening
7. History of alcohol or drug abuse or dependence
8. Pregnancy or breast-feeding
9. Patients who have had gastrointestinal operations that could affect drug absorption.
10. Allergy to Risperidone or Aripiprazole or hypersensitiveness to any drug
11. Patients who discontinued long-acting antipsychotics less than one treatment cycle before screening
12. Refractory schizophrenia patients who did not respond to treatments of two different type antipsychotics with adequate dose and course, or patients who did not respond to Clozapine
13. Patients who had Electroconvulsive Therapy (ECT) in the past 6 months After washout

1. Diagnosis of other mental diseases besides schizophrenia during the washout period 2. Significant abnormal ECG or laboratory examination results (ALT,AST\>1.5 times of higher limit of normal range), not suitable to be enrolled based on the investigator's discretion.

-
Pulse CO-Oximetry Noninvasive Monitoring and Laboratory Measurements of Subject Blood Samples

Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers.

Noninvasive readings from subjects done according to manufacturer's directions of use compared to simultaneously derived blood samples measured on in vitro analyzers

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any age ≥ 3 kg.
* Subjects may include healthy volunteers, outpatient or inpatient populations

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, etc.
* Subjects deemed not suitable for study at the discretion of the investigator
Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression

The goal of this observational study is to understand the effects of gut microbiota dysbiosis treatment in patients with inflammatory bowel disease (IBD) combined with depression. The main question it aims to answer is:

Does fecal microbiota transplantation (FMT) improve depression symptoms in IBD patients by altering GABA levels in the medial prefrontal cortex?

Participants already undergoing fecal microbiota transplantation (FMT) as part of their regular medical care for IBD and comorbid depression will undergo regular assessments of GABA levels, gut microbiota, and depression symptoms for the duration of the study.

The high incidence of inflammatory bowel disease (IBD) combined with depression increases the risk of disease recurrence and treatment failure. Previous research by our team has found a positive correlation between decreased levels of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) in the medial prefrontal cortex of IBD patients and the severity of depression. However, the underlying pathological mechanisms remain unknown. Prior studies have suggested that GABA regulates activity within neural circuits in the brain, and the levels of GABA in the brain are influenced by the gut microbiota. Based on this premise, our study aims to treat gut microbiota dysbiosis in IBD patients with comorbid depression using fecal microbiota transplantation (FMT). Our team will analyze the correlation between changes in GABA levels in the medial prefrontal cortex and gut microbiota using techniques such as metagenomics, metabolomics, and magnetic resonance spectroscopy imaging. Additionally, resting-state functional magnetic resonance imaging (fMRI) is used to perform dynamic causal modeling of the neural circuit in the brain to elucidate the regulatory mechanism of GABA level changes on these circuits. Finally, the investigators will validate the research findings using a dextran sulfate sodium (DSS)-induced colitis mouse model to explore the neurochemical mechanisms underlying IBD comorbid with depression. The results of this study will not only provide a deeper understanding of the regulatory role of changes in brain GABA levels on neural circuits but also offer a theoretical basis for the use of fecal microbiota transplantation in treating gut microbiota dysbiosis in IBD patients and prevent complications such as depression.

Eligibility Criteria:
Inclusion Criteria:

aged 18-65 years right-handed active disease (CDAI score ≥150, Mayo score \>2).

Exclusion Criteria:

previous brain surgery those with severe and unstable physical diseases those with contraindications for MRI who cannot tolerate long-duration MRI examinations.
Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.

The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.

This single-center, prospective study will be conducted at one site in the United Kingdom. Up to 30 subjects will be enrolled and treated with Gel-Bead. Prospectively. Enrolled Gel-Bead subjects will be followed at 1-month and 3-months post-procedure.

Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton. This study evaluated 20 subjects in five different treatment groups for the treatment of symptomatic uterine fibroids. The five treatment groups include gelatin foam slurry, Embospheres, polyvinyl alcohol (PVA), Bead Block and Embozenes.

Eligibility Criteria:
Inclusion Criteria:

1. Female, age 18 years or older
2. Symptomatic uterine fibroid(s) requiring treatment per the investigators assessment
3. Negative serum pregnancy test at the Baseline visit and practicing effective contraception during the study
4. Willing to provide written informed consent prior to initiation of study procedures
5. Willing to comply with the specified study assessments and follow-up requirements

Exclusion Criteria:

1. Known hypersensitivity to porcine products or intravascular contrast material
2. Vascular anatomy or blood flow precluding correct catheter placement or embolic injection
3. Presence of collateral vessel pathways potentially endangering normal territories during embolization
Cutaneous Microcirculation After Plasma Therapy

In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds, burn scars, flaps and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that Plasma Therapy can accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of Plasma Therapy on second-degree burns, superficial wounds, burn scars, flaps and chronic wounds in a human in-vivo setting for the first time.


Eligibility Criteria:
Inclusion Criteria:

Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.

Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.

Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.

Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. No soft tissue injury must be evident.

Group E (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.

Group F (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.

Group G (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.

Group H (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups E-G must be evident. No soft tissue injury must be evident.

Group I (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn wound.

Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn wound.

Group K (n=20): Consent-capable male and female patients ≥18 years of age received a flap.

Group L (n=20): Consent-capable male and female patients ≥18 years of age received a flap.

Exclusion Criteria:

General exclusion criteria

* below 18 years of age
* wounds requiring artificial respiration, since consent for the study participation is unobtainable

Exclusion criteria groups A, B, D, E, F, H:

* peripheral arterial occlusive disease
* vasculitis
* diabetes mellitus
* chronic kidney or liver disease
* cardiac dysfunction
* arterial hypo- or hypertension

Anamnestic exclusion criteria

* ongoing immunosuppressive or chemotherapy treatment
* drug abuse
* systemic skin diseases
* systemic and local cortisone therapy
Minimally Invasive Holmium:YAG Laser Blepharoplasty

The purpose of this research study is to is to evaluate the safety and effectiveness of the FDA approved Holmium:YAG laser for reducing lower eyelid bags.

The researchers are interested in learning if the more precise Holmium:YAG laser can effectively tighten the orbital septum, a barrier of the orbit which holds fat in the bony orbit, while resulting in less unintentional surrounding damage and side effects.

Eligibility Criteria:
Inclusion Criteria:

* male/female 30 years and older
* have pronounced lower eyelid fat pads.

Exclusion Criteria:

* based on medical problems.
* Previous surgery or trauma to lower eyelid or orbit.
* pregnant or lactating.
Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)

The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an imaging agent with cardiac MR. If found useful, it will help us establish a protocol for regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators will compare regadenoson with dobutamine so each participant will undergo two studies. A cardiac MR stress test with regadenoson and with dobutamine. The investigators participants will include patients with history of COPD and Asthma, so it will also help us determine feasibility of Regadenoson in these patient's subgroups.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 40 to 85 years with OBSTRUCTIVE AIRWAY DISEASES (ASTHMA AND COPD) and a forced expiratory volume (FEV1) \> 0.5.
* Patients should have a clinical indication to undergo cardiac stress test with dobutamine.

Exclusion Criteria:

* Those with pacemakers, defibrillators, functioning neural stimulator devices or other implanted electronic devices.
* Ferromagnetic cerebral aneurism clips or other intraorbital and intracranial metal.
* An allergy to Gadolinium or other severe drug allergies.
* Acute myocardial infarction within 3 months.
* Moderate or severe aortic stenosis or other significant valvular disease;
* Claustrophobia.
* High grade (2o or 3o) AV Block.
* Closed angle glaucoma.
* Participants unable to provide informed consent.
* Renal dialysis (subjects with moderate-to-severe renal impairment defined as eGFR \< 60 mL/min.
* A contraindication to receipt of dobutamine.
* Participants with known coronary artery disease will be included with the exception that patients with left main or narrowings \>50% in the distributions of the left anterior descending, circumflex, and right coronary artery will be excluded.
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

Eligibility Criteria:
Inclusion Criteria:

* Be aged 18 to 65 years inclusive
* Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
* Give written informed consent
* Be in good general health
* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
* If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

* Medical condition which requires pre-medication (antibiotics) prior to dental
* Visits/procedures
* Allergy to chlorhexidine
* Advanced periodontal disease (gum disease)
* 5 or more decayed, untreated dental sites (cavities)
* Diseases of the soft or hard oral tissues (gums or palate)
* Orthodontic appliances that interfere with plaque rating
* Abnormal salivary function
* Use of drugs that can affect currently salivary flow or production
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)
* Pregnant or breastfeeding.
* Participation in another research study in the month preceding this study
* Allergic to common toothpaste or mouth rinse ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes