cyrilzakka/clinical-trials huggingface dataset:
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects

Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.

The purpose of this study is to evaluate changes in the fecal and salivary/urinary microbiota during vancomycin treatment of children and adults with Primary Sclerosing Cholangitis (PSC), identify features of the host microbiota that are associated with disease activity and/or response to treatment and further delineate the immunological effects of oral vancomycin treatment of PSC. This study will correlate changes in microbiota with the immunological effects of oral vancomycin in children and adults with PSC. The results of this proposal will lead to new and validated targets for diagnosis and treatment of PSC that will have high impact in the short and long term for patients and their families.

Interim results were published in Abarbanel et al, J Clin Immunol 2013 (see References).

Eligibility Criteria:
Inclusion Criteria:

* PSC Diagnosis: Liver biopsy and/or imaging (MRCP, ERCP, CT, or US
* Colonoscopy within 1 year or starting of study
* 2 groups:

  1. IBD (Inflammatory bowel disease) and PSC: details of extent and type of IBD
  2. No IBD and PSC, but positive p-ANCA or ASCA serologies indicating possible IBD.

Exclusion Criteria:

* Allergy to Vancomycin
* PSC not associated with IBD or NO positive IBD antibodies (p-ANCA \[anti- neutrophil cytoplasmic antibody\] or ASCA \[anti-Saccharomyces cerevisiae antibody\])
* Cholangiocarcinoma
* On oral or topical (enemas or suppositories) corticosteroids,topical mesalamine, or biologics (infliximab, adalimumab, certolizumab).
The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

This pilot study tests the hypothesis that the medication nitric oxide extract from beetroot juice improves blood flow to the skeletal muscle during exercise. The investigators will use cutting edge technology with contrast enhanced ultrasound to visualize the microvascular blood supply to the forearm. Animal studies have shown reversal of muscle damage with improved delivery of blood to the exercising muscle. This research aims to understand the mechanism of action of this medication in a way it has never been studied before. The results may help benefit individuals with muscular Dystrophy in the future.

The subjects are asked to perform a graded hand-grip exercise while blood flow to the skeletal muscle is visualized by contrast enhanced ultrasound.

This is done at baseline and after taking the study agent.

Eligibility Criteria:
Inclusion Criteria:

* Healthy man, aged 18 to 45 years, currently taking no medication. OR
* Clinical diagnosis of Becker Muscular Dystrophy (BMD), aged 18 to 45 years, and currently taking no medication.

Exclusion Criteria:

* Hypertension, diabetes, heart failure, liver disease
* ECG evidence of prolonged QT interval
Interpersonal Psychotherapy for Treatment Resistant Depression

The purpose of this study is to determine whether combination of antidepressant drugs plus interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant depression.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnose of unipolar treatment resistant depression

Exclusion Criteria:

* Patients diagnose of: bipolar disorder, psychosis, high suicide risk, Intellectual disability, illicit drug dependence.
* Currently in or having received psychotherapy in the last 4 weeks
A Clinical Study to Evaluate DNTH103 in Adults with Multifocal Motor Neuropathy

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with multifocal motor neuropathy (MMN).


Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out
2. Adult males and females, 18 to 75 years of age (inclusive)
3. Weight range between 40 to 120 kg
4. Confirmed diagnosis of definite or probable MMN
5. Evidence of:

   1. Responsiveness to Ig treatment; and
   2. Receiving a stable Ig regimen
6. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability
7. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception
8. Male participants must be surgically sterile for at least 90 days prior to Screening or agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception

Exclusion Criteria:

1. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could impact efficacy assessments
2. Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy)
3. Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. If a participant has previously used these medications, the last dose must be at least 6 months prior to randomization
4. Currently or previously on complement inhibitors including in a clinical trial setting
5. Prior history (at any time) of N. meningitidis infection
6. Diagnosis of an autoimmune disorder other than MMN
7. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening
8. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone
9. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (Day 1)
10. Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes
11. Any other condition, including mental illness or prior therapy, that in the opinion of the Investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements
Efficacy of Corticoid Infiltration in Quadratus Lumborum Syndrome

This study has the primary goal of evaluating the efficacy of corticoid infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration.

This study has the primary goal of evaluating triamcinolone's efficacy on the ultrasound- guided infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration.

It is an interventional study, double-blinded and randomized, in a sample of patients followed in the Chronic Pain Unit (Hospital of Braga, Portugal), proposed for ultrasound infiltration of the quadratus lumborum muscle.

The selection of the patients will take into account the inclusion and exclusion criteria, until reach the required sample size (66 patients). The confirmation of the inclusion criteria will be done by a physiatrist blind to randomization.

Different protocols will be randomly applied to patients after obtaining written informed consent.

The techniques will be performed by two anesthetists. The data will be obtained through questionnaires filled out on the day of the technique and in the course of 1, 3 and 6 months in chronic pain consultation and by telephone call 72 hours after the procedure. It will be a psychologist, blind to randomization, to fill the questionnaires.

Patients will be also evaluated in consultation, at the same time, the course of 1, 3 and 6 months.

After the data collection it will be performed a statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

I) patients followed in the Chronic Pain Unit proposed to have ultrasound- guided infiltration of the quadratus lumborum muscle.

II) written informed consent.

III) presence of 4 of the following clinical criteria evaluated by a physiatrist:

* pain below the 12th rib and 5 cm lateral to the transverse process of L1 during palpation, with referred pain to the iliac crest;
* pain on palpation of the trigger points in the quadratus lumborum muscle;
* exacerbation of the pain with with postural changes when lying down, walking, sitting and/or squatting;
* lumbar pain with muscle stretching;
* painful palpation of trigger points at the level of L4 vertebral body, 1 to 2 cm above the iliac crest.

Exclusion Criteria:

* rheumatologic disease;
* psychiatric disease;
* neurological disease;
* history of anticoagulation use;
* pregnant patients;
* uncontrolled diabetes mellitus;
* patients on corticosteroid therapy;
* allergy to the medication to be used;
* anterior realization of ultrasound techniques for low back pain ;
* anterior realization, of invasive techniques, less than 6 months, with administration of medication.
Pilot Trial: Bioavailability Animal vs. Plant Protein Drink

A pilot study is being conducted to compare a new plant-based protein drink to commercially available animal-based protein drinks. The goal is to assess if the plant-based drink delivers amino acids to the bloodstream as effectively as the animal-based drinks, potentially offering a viable option for those on plant-based diets.

The study will involve approximately 12 healthy adults aged 18-40. Each participant will try all three drinks (the new plant-based drink, a commercial animal-based drink, and another animal-based recipe) on separate days in a randomized order. Before and after (30, 60, and 90 minutes) consuming each drink, a small blood sample will be drawn to measure amino acid levels (leucine).

By comparing the results, the investigators hope to determine if the plant-based drink can match the effectiveness of animal-based protein drinks in delivering essential nutrients. This research could contribute to the development of sustainable and nutritious plant-based protein alternatives.


Eligibility Criteria:
Inclusion criteria

* Gender: male and female
* Age: 18-40 years
* Signed written informed consent

Exclusion criteria

* Smoking history
* Cardiovascular diseases
* BMI \> 35 kg/m2
* Caffeine consumption \< 1 day before the study participation
* Allergies: Soy, Peas, Milk, Lactose, Fructose
* High intensity exercise \<2 days before study participation
Efficacy and Safety of MW031 in PMO Subjects

This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .


Eligibility Criteria:
Inclusion Criteria:

* BMD -4.0\<T-score ≤-2.5 at either the lumbar spine or total hip or femoral neck
* All subjects must have at least one of following additional the risk factors:history of fracture, parental history of hip fracture, increased bone turnover rate at screening, low body weight, elderly (age≥65year)，current smoker
* Postmenopausal is defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea, or bilateral oophorectomy \>2 years after surgery. If bilateral oophorectomy status is unknown, use follicle-stimulating hormone (FSH) levels \> 40 mIU/mL to confirm surgical postmenopausal status.

Exclusion Criteria:

* Bone/metabolic disease
* Hyperparathyroidism or hypoparathyroidism
* Thyroid condition: Hyperthyroidism or hypothyroidism
* Rheumatoid arthritis
* Malignant tumors
* Malabsorption syndrome
* Oral bisphosphonates
Pulsed Lavage in Implant-Based Breast Reconstruction

To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.

After being informed of the study including potential risks and benefits, all patients giving consent who meet eligibility requirements will undergo randomization into either the pulsed lavage arm (receive mastectomy pocket wash out using pulsed lavage) or the no pulsed lavage arm (pulsed lavage will not be used). Randomization will occur using a random number generator with even numbers resulting in a pulsed lavage washout and odd numbers resulting in no pulsed lavage washout.

The patients will be followed in clinic for a maximum of 3 months to evaluate the surgical site. The two cohorts will be compared at the end of the study to determine whether there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Between 18 and 75 years of age, inclusive
* Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy
* Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document

Exclusion Criteria:

* Male
* \< 18 years of age or \> 75 years of age
* Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511

This is a multicenter, open-label, continuation study to allow subjects who have previously received Toca 511 to continue to receive Toca FC and to allow for extended safety observations. Subjects will be seen on an every six week basis for 1 year or longer. Subjects who continue to receive Toca FC will receive the dose described in the "parent" protocol. If the Toca FC dose is adjusted for any reason, the serum concentration will be monitored. Gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scans will be performed as per standard of care.

If the subject has recurred/progressed, repeat intracranial injection of Toca 511 followed by Toca FC treatment may be offered to consenting patients.

Subjects who enter the study to continue Toca FC and subsequently discontinue Toca FC, and subjects who are only willing or able to perform limited testing will have viral testing alone, at the appropriate intervals.

After the first year, subjects will be seen twice yearly for the next 4 years and then contacted yearly for the next 10 years.

All subjects will be followed on study for at least 5 years regardless of whether they are taking Toca FC.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form
* Subject received Toca 511 in prior study.
* Subject is willing to abide by protocol

Exclusion Criteria:

* Subject has history of allergy or intolerance to flucytosine
Study of Supplement's Antioxidant Properties That Contains Natural Extracts

While it is well accepted that a low level of RONS production is necessary to maintain physiological function, too much formation of RONS are believed to participate in biomolecules damage. Damage of lipids, proteins and DNA/RNA, to cellular and tissue level, as a consequence of oxidative stress has been linked to a number of serious diseases, including cancer, cardiovascular diseases (CVDs) such as hypertension and atherosclerosis, neurodegenerative diseases such as Parkinson's disease and Alzheimer's dementias, diabetes and the process of aging.

The dietary intake of antioxidants is thought to play a major role in oxidative stress network. Many epidemiologic studies have reported an inverse association between vegetable and fruit consumption with reduced risk of chronic diseases, especially cancer and CVDs. However, although many clinical trials have been conducted with vitamins (E, C or their combinations) their in vivo protective effect remains uncertain. Therefore the possibility that the complex mixture of phytochemicals in foods may contribute to their protecting effects has been raised. In this concept, it is possible multiple compounds to act through complimentary or synergistic mechanisms to present a greater biologic effect than can be achieved by any individual component To investigate this hypothesis, a double-blind, randomized, and placebo-controlled clinical trial was conducted in order to investigate the effects of a multi-micronutrient supplement against oxidative stress in apparently healthy adults.

This was a double-blind, block randomized, parallel-arm, placebo-controlled, eight-week study. Initially 77 apparently healthy volunteers were recruited to participate in the study. 62 volunteers were enrolled in the study and assigned to either the MM group (n = 32) or the placebo group (n = 30) using a stratified randomization to guarantee comparability of age, sex and BMI distribution between the two groups. The randomization code was prepared by a staff member who was not involved in running the trial, by using computer-generated random numbers. At the initiation of the study, the subjects received 5 bottles (0.5L each) of the MM or placebo, which were made indistinguishable by their identical packaging. At 4 weeks the subjects received again 5 bottles. The subjects were asked to consume 80mL per day, preferably after meals. The dose was chosen based on the commercially recommended level. At each visit, the remaining volume of the supplement was counted by research coordinators. The subjects were excluded from the analysis if they consumed \<80% of the recommended dose.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI: 23-30

Exclusion Criteria:

* regular use of dietary supplements or medications
* being on slimming or any other special diet
* hypertension
* metabolic or endocrine disease
* gastrointestinal disorders
* recent history of medical or surgical events
Clinical Markers of Panic and Generalized Anxiety Disorder

The goal of this observational study is to compare socio-demographic and clinical features in patients affected by Generalized Anxiety Disorder (GAD) and by Panic Disorder (PD). The main questions it aims to answer are:

* which socio-demographic/clinical markers are associated to GAD or PD diagnosis?
* which factors are associated with a longer duration of untreated illness (DUI) in GAD and in PD? Participants will signed a written informed consent and socio-demographic/clinical variables will be retrospectively collected. Researchers will compare GAD and PD groups in terms of socio-demographic and clinical features, including DUI, to better characterize the two disorders and to investigate factors associated to a longer DUI.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years;
* ability and willing to give informed consent;
* fluency in Italian language;
* diagnosis of GAD or PD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, 5th edition.

Exclusion Criteria:

* intellectual disability;
* lack of clinical and socio-demographic information;
* patients treated for less than three months in the outpatient clinics for the impossibility of a comprehensive collection of clinical variables.
Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion

Evaluating the effect of intralipid on the natural killer cells

This study will done on women with recurrent spontaneous abortions having increased NKCELLS activity and evaluate the effect of Intralipid on them after re-estimation of NKcells activity again after one week of Intralipid adminstration

Eligibility Criteria:
Inclusion Criteria:

* All women icluded having recurrent spontaneous abortions equal or more than twice.
* Alittle women having increased NKCELLS activity.

Exclusion Criteria:

* Any other diseases causing miscarriage as autoimmune (lupus erythematosus or antiphospholipid antibodies syndrome )or endocrinopathy (diabetes mellitus, thyroid disorders and hyperprolactinaemia)or thrombophilia (factor v leiden mutation, protein c or s deficiency, prothrombin G20210A mutation, antithrombin III deficiency ) or abnormal karyotyping to one or both of parents or previous history of hormonal contraception or intrauterine device usage at last 3 months or any contraindications for intralipid usage.
Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is considered a possible cause of infectious gastrointestinal disease in adults and children. DF has a particular high prevalence in children, and it is suspected that children present more symptoms in infection than adults. However, evidence of causality is lacking, treatment regimens are largely untested in controlled trials, and the most commonly used antibiotic against DF in Denmark, metronidazole, has never been tested against placebo.

Main objective: To determine the clinical effect of metronidazole in DF-infected children with gastrointestinal complaints, where no other aetiology is known and no other gastrointestinal pathogens could be shown.


Eligibility Criteria:
Inclusion Criteria:

* Patients with samples investigated at Statens Serum Institut.
* Faecal sample (index) positive for Dientamoeba fragilis (DF) by realtime PCR, within \< 7 days.
* No faecal samples positive for DF within the period: 3 months prior to and up to index-sample.
* Telephone interview to parents no later then 14 days after result from index-sample.
* Age 3-12 years old.
* Place of residence: Island of Zealand, incl. capital region.
* Symptoms consistent with gastrointestinal infection of DF: Either 1) ≥ 2 episodes of diarrhea per week or 2) ≥ 2 episodes of stomach ache per week or 3) ≥ 2 of the following symptoms: Anorexia, Failure to thrive, Anal itching, excessive flatulence, other change in bowel movements.

Exclusion Criteria:

* Expected non-compliance.
* Objection to subject participation from referring physician.
* Underlying illness or comorbidity, incl. known gastrointestinal illness (both infectious and non-infectious), but excluding constipation.
* Known liver disease or intolerance/allergy to metronidazole.
* Positive screening for other intestinal pathogens, which may explain subject symptoms.
* Treatment with metronidazole outside of study within study period.
* Weight \> 50 kg