cyrilzakka/clinical-trials huggingface dataset:
Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific interventions.

The objective of this randomized, controlled pilot study is to evaluate the effect of Microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective is to compare the effects of different currents. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific intervention.

Group 1, 2 and 3 will receive 10 sessions of treatment in a treatment phase of four weeks. Assessments for group 1, 2, and 3 will be scheduled for screening (T0), at the first day of treatment (T1), at the end of treatment (T2) and three months after the end of treatment (T3). Group 4 will be assessed at a screening visit T0, at T1, at T2 (approximately 21 days after T1), and at T3 (three months after T2). Patients will be recruited based on the records of the clinic.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee
* pain intensity \> 3 on the numerical rating scale (0-10)

Exclusion Criteria:

* knee arthroplasty
* gravity
* dermal Irritation at the skin of the knee
* carcinoma
* known osteoarthritis grade 4 (Kellgren and Lawrence score)
Study of Efficacy of a Probiotic and Postbiotic in Overweight and Obese Individuals

The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.

Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.

Eligibility Criteria:
Inclusion Criteria:

Male and female subjects from 18 to 65 years old.

Established diagnosis of overweight (BMI ≥ 25 and up to 34.9)

Waist circumference ≥ 102 cm for men

Waist circumference ≥ 88 cm for women

Signature of the informed consent letter.

Agreement to comply with the protocol and study restrictions

Exclusion Criteria:

Diagnosed and pharmacologically-treated type 1 or type 2 diabetes

Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease

Immunosuppression or ongoing therapy causing immunosuppression

Pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia

Subjects consuming antibiotics in the previous 2 months

Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.

History of chronic active inflammatory disorders

History of bariatric surgery

History of any chronic gastrointestinal disease (e.g. IBD).

Known hypersensitivity to any ingredients in the active or placebo products.
Variance of Oral Methadone Dosage: Description of Implicated Factors

The purpose of this study is to describe clinical, pharmacokinetic and genetic factors associated with the variance of oral methadone dosage for patients at the steady state of heroin dependence maintenance treatment. The hypothesis is that the investigators can predict 70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam challenge.

Patients at the steady state of methadone maintenance treatment may receive oral dosage ranging from 5 to 130 mg per day in our clinical practice. This study is aimed at providing a comprehensive cross-sectional description of factors involved in this variance:

* comorbidity with addictive and psychiatric disorders
* severity of pre-existing heroin dependence
* function of CYP 3A4 enzyme assessed with oral midazolam challenge
* genetic polymorphisms of enzymes implicated in methadone pharmacokinetic and pharmacodynamic (CYPs, MDR1, OPRM1, COMT)

The expected result is a predictive equation of oral methadone dosage at steady state.

Eligibility Criteria:
Inclusion Criteria:

* heroin dependence
* under maintenance treatment with methadone
* at steady state: stable oral methadone dosage since 3 months at least

Exclusion Criteria:

* current heroin dependence or abuse
* current cocaine and/or alcohol and/or sedatives dependence
* pregnancy
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients

To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Standard therapy for infections.
* Acyclovir.
* Ganciclovir.
* Allowed only with permission of Wyeth-Ayerst medical monitor:
* Zidovudine (AZT).
* Immunomodulators.
* Specific therapy for malignancies (including Kaposi's sarcoma).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Evidence of severe liver dysfunction (serum albumin \< 3 g/dl, SGOT or SGPT \> 5 x upper limit of normal, prothrombin time \> 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).
* Evidence of AIDS-related central nervous system involvement.
* Disseminated Kaposi's sarcoma.

Concurrent Medication:

Excluded without permission of Wyeth-Ayerst medical monitor:

* Zidovudine (AZT).
* Immunomodulators.
* Specific therapy for malignancies (including Kaposi's sarcoma).

Patients with the following are excluded:

* Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex.
* Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.
* Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 4 weeks of study entry:

* Systemic antiviral agents.
* Immunosuppressive agents.
* Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.

Patients must:

* Have a diagnosis of AIDS or AIDS related complex (ARC).
* Demonstrate intolerance or refusal to take zidovudine (AZT).
* Provide written informed consent.
Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria
* Visual analog pain score between 40 and 90 mm
* Right-hand dominance

Exclusion Criteria:

* Suicidal risk
* Substance Abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Autoimmune disease
* Uncontrolled narrow-angle glaucoma
* Active liver disease
* Cancer
* Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue
* Unstable endocrine disease
* Prostatic enlargement
Reliability And Validity Of Urdu Version Of Disabilities Of The Arm, Shoulder And Hand Questionnaire

The goal of study is to convert Disabilities Of The Arm, Shoulder And Hand Questionnaire into Urdu and test its reliability and validity among the Pakistani citizens. Also check its correlation with Boston carpal tunnel syndrome questionnaire and visual analogue scale as well.

A cross-sectional study will be conducted after approval from ethical review committee of Riphah international university of Faisalabad. Total of 90 participants will be included in this study from different community areas, hospitals and rehabilitation centers with carpal tunnel syndrome. 71 of them will be male and 19 will be female. Disabilities of the Arm, Shoulder, and Hand questionnaire will be correlated with Boston carpal tunnel syndrome questionnaire and visual analogue scales. These questionnaires will be filled by participants firstly for baseline, secondly after treatment and third one week later as a follow up. Written informed consents will be taken before filling questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years.
* Subjects with phalen's and Tinnel's test positive.

Exclusion Criteria:

Participants who had following conditions:

* Diabetes mellitus, thyroid disease, rheumatoid arthritis, radiculopathy of cervical spine, cognitive impairment.
* Hand surgery within previous 3 months.
* Difficulty in understanding of language.
* Musculoskeletal disorder.
Noninvasive Positive Pressure Ventilation for ALI/ARDS:a Multicentre Randomized Controlled Trial

with appropriate inspired oxygen concentrations, NPPV would prevent intubation and hence avert the poor outcome associated with the need of invasive ventilation in patients with ALI/ARDS.

Noninvasive positive-pressure ventilation (NPPV) is increasingly being used in the care of patients suffering acute respiratory failure. High-level evidence supports the use of NPPV to treat exacerbation of chronic obstructive pulmonary disease (COPD). More recently, NIV has shown to reduce the need for intubation in selected groups of patients with severe cardiogenic pulmonary edema, immunosuppression, and respiratory failure after lung resection. In their subgroup analysis of the five randomized control trials, however, patients with acute lung injury (ALI) or ARDS still couldn't avoid intubation and death even treated with NPPV. Till now, there has been no randomized controlled study of NPPV in patients with ALI or ARDS. We hypothesized that in patients with ALI/ARDS, early use of NPPV, providing appropriate inspired oxygen concentrations, would prevent intubation as the primary end-point variable, hence avert the poor outcome associated with the need of invasive ventilation. Accordingly, we conducted a prospective, randomized controlled trial to assess the efficacy of NPPV compared with a standard regime consisting of high-concentration oxygen therapy.

Eligibility Criteria:
Inclusion Criteria:

* Meet the ALI/ARDS criteria

Exclusion Criteria:

* Age \> 85
* pH \< 7.35 or PaCO2 \>50mmHg
* Glasgow Coma Scale (GCS)\<11
* Airway or facial deformity
* Pneumothorax or pneumomediastinum
* Unable to spontaneously clear secretions from their airway
* Respiratory arrest
* Shock or hemodynamic instability (systolic blood pressure \<90 mmHg associated with decreased urinary output (\<20 mL.h-1) despite fluid repletion and use of vasoactive agents) of other causes
* Severe ventricular arrhythmia or active myocardial ischemia
* Severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score\>1)
* End-stage patients who are expected to survive less than six months
* Severe abdominal distension
* Refuse to receive NPPV
* Unable to cooperate with the application of NPPV
Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.

The purpose of this study is to introduce and test the usefulness of a reflective process meant to empower people with chronic pain and help support participant's resiliency and thriving.

The study team hypothesizes that:

-Greater or equal to 80 percent of participants will report that the intervention was relatively easy to understand after orientation, low burden, potentially effective, and will have completed at least 2 of the 3 reflective tools.


Eligibility Criteria:
Inclusion Criteria:

* Persistent or recurrent pain lasting longer than 3 months
* Able to read and write English

Exclusion Criteria:

* Cancer (History of any bone-related cancer or cancer that metastasized to the bone; Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months; History of any cancer treatment in the last 24 months)
* Active substance abuse
* Uncontrolled depression or psychosis
* Visual or hearing difficulties that would preclude participation
* Individuals started receiving disability or compensation within the past year, or currently involved in litigation
* Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial.
* Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction)
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy

In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety.

The goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.


Eligibility Criteria:
Inclusion Criteria:

* • Ability to understand read and sign the informed consent form.

  * Age between 30 and \<91 years
  * Ability to understand and follow instructions and study procedures
  * Willingness to comply with all study procedures and be available for the duration of the study
  * Ability to apply eye drop medication and willing to adhere to study medication regimen
  * Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the study investigator.
  * Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
  * Fuchs dystrophy grades 2-4 on the Krachmer grading scale
  * Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema
  * Clear peripheral cornea with an endothelial cell count \>1000 cells/mm2 on specular microscopy
  * Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment
  * The patient is dissatisfied with current vision
  * The patient is otherwise to be offered a corneal graft
  * For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
  * Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation

Exclusion Criteria:

* • Uncontrolled glaucoma (IOP \>25 mmHg)

  * Presence of secondary corneal pathology such as infective or autoimmune keratitis
  * Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy
  * History of herpes simplex virus or cytomegalovirus keratitis
  * Prior endothelial keratoplasty
  * Aphakic in study eye.
  * Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study
  * For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.
  * Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.
Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer

As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Therefore, we put forward the hypothesis that "appendectomy leads to intestinal microecological disorders and then increases the risk of colorectal cancer". In this study, the feces of normal controls, appendectomy and patients with colorectal cancer were collected, and the specific changes of intestinal flora after appendectomy were explored in detail from the level of family, genus and species by macrogenomic sequencing. Then through functional gene analysis, metabolic pathway analysis and other methods to explore the molecular mechanism of colorectal cancer risk changes and the changes of microflora involved, and verified by mouse fecal bacteria transplantation animal experiment.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing appendectomy due to appendicitis;
* 6-36 months after appendectomy;
* Patients with no obvious abnormality observed by colonoscopy;
* Age between 20 and 85.

Exclusion Criteria:

* A. Any history of malignancy or disease
* Any inflammatory bowel disease (IBD) prior to study inclusion;
* Antibiotics and hormone drugs taken within the last three months;
* Patients with severe systemic diseases (severe diabetes, hypertension or autoimmune diseases, etc.);
* Severe clinical symptoms of digestive tract (severe diarrhea, constipation, purulent disease, etc.) within half a year.
PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.

The goal of this clinical trial is to evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life. Researchers will compare an experimental drug (Plasma Rich in Growth Factors) to a control corticosteroid solution in saline solution.


Eligibility Criteria:
Inclusion Criteria:

* Patients of legal age (≥18 years).
* Patients diagnosed by Magnetic Resonance Imaging (MRI) with lumbar intervertebral disc degeneration(s) (Pfirrmann Scale \> 1).Patients with positive signs in MRI at L4-L5 and/or L5-S1 levels, including rupture of the annulus fibrosus, annular fissure, with or without disc herniation in its protrusion form will be included.
* Patients with low back pain with symptoms of low back pain for at least 3 months of evolution that has not responded to drug treatment.
* Numerical pain scale (COMI PAIN SCORE): between 6 and 10, average of the last month.
* Availability of an MRI performed in the last six months to allow the diagnosis.
* Availability of a complete blood test (hemogram, basic biochemistry and coagulation tests) performed in the last two months.
* Signed informed consent to participate in the clinical trial and authorization for data processing by the different centers involved for subsequent scientific publication.

Exclusion Criteria:

* Patients with lumbar fracture, extruded herniated discs and herniated discs with signs of calcification are excluded.
* Patients with severe discopathies at levels adjacent to L4-L5 and/or L5-S1.
* Patients who have previously undergone spinal surgery.
* Patients who have undergone invasive procedures on the spine in the last 6 months, such as infiltrations, blocks, lavage or lumbar rhizolysis.
* Patients with neurogenic motor claudication.
* Patients with severe cardiovascular diseases, central nervous system diseases, epilepsy, coagulopathies, immunological diseases, infectious diseases (e.g. Hepatitis B and C, HIV, Syphilis), cancer or neurodegenerative pathologies.
* Patients with a history of drug use (e.g. alcoholism or others) and mental illness or marked psychological conditions related to pain.
* Morbidly obese patients (BMI \> 40 kg/m2).
* Women who are pregnant or breastfeeding or women of childbearing age who are not taking effective contraceptive measures as outlined in the Clinical Trials Facilitation and Coordination Group (CTFG) "Recommendations Regarding Contraception and Pregnancy Testing in Clinical Trials" V 1.1.
* Patients with pathologies that produce marked alterations in the efficacy of PRGF or coagulation, such as, for example: poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%), hematological alterations (thrombopathy, thrombopenia, anemia with Hb \< 9), being subjected to immunosuppressive and/or dicoumarinic treatments, or any treatment with systemic corticosteroids during the 6 months prior to inclusion in the study
* Patients who present allergy to any component of the sedation or to the corticoid.
* Patients who have received previous back treatment with PRGF in the last 6 months.
Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).

Between 2017 and 2019, we conducted an open-labelled, randomized controlled trial to evaluate for non-inferiority in the post-booster serotype-specific geometric mean concentrations (GMC's) in children randomized to receive either PCV10 or PCV13 as a 1+1 schedule (with the first dose occurring either at 6 or 14 weeks of age) compared to infants who received a two dose primary series (6 and 14 weeks of age). All six study groups received a booster dose at 40 weeks of age, and serotype-specific IgG and opsonophagocytic activity was measured one-month post booster. Subjects were planned to be followed-up until 18 months of age as part of the initial study. In the present study, we propose to extent the follow-up of the cohort to include annual visit at 3, 4 and 5 years of age, to evaluate the sustainability of the humoral immune response of the different PCV dosing schedules.

Eligibility Criteria:
Inclusion Criteria:

1. Children between and including the ages of 36 - 38 months of age at the time of first blood sampling;
2. Subjects who previously participated in the PCV1+1 study and received the full study vaccination regime as per protocol;
3. The parent or legal guardian of the child must be able and willing to provide written informed consent for all 3 visits and comply with all study requirements;
4. The parent or legal guardian of the child must indicate the intention to remain in the study area for the duration of the trial - or be willing to bring the child for all visits.

Exclusion Criteria:

1. Receipt of any additional pneumococcal vaccine since the end of participation in the PCV1+1 study;
2. Any known or suspected immunodeficiency condition which could affect immune response to vaccination, including living with HIV;
3. Receipt of any immunoglobulins and/or blood products less than 6 months prior to blood sampling;
4. Parent/legal guardian unable or unwilling to attend scheduled study visits.