cyrilzakka/clinical-trials huggingface dataset:
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis

This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis.

The present study aims to assess the feasibility, pilot efficacy, and safety of FMT for patients with Systemic Sclerosis.

Participants will undergo two interventions in this present study.

In the first intervention, participants are randomized 1:1 for either active FMT or Placebo. This first intervention consists of two doses of FMT with a 3-7 day gap.

In the second intervention, all participants receive 1 dose of active FMT treatment.

This study design allows researchers to evaluate the safety of FMT in this patient group, and compare the effects of FMT in the FMT-treated group vs the placebo group, to see if FMT promotes remission of Chronic diarrhea. Furthermore, researchers will be able to gain insights into whether 2 initial doses are superior to one.

Eligibility Criteria:
Inclusion Criteria:

* Participants \> 18 years
* Fulfilling and previously diagnosed with SSc according to the 2013 American College of Rheumatology/European League against rheumatisms SSs classification criteria\[23\] by rheumatologist or dermatologist.
* Chronic diarrea is defined as loose or watery stools, three or more times a day, a minimum of 50% of the days within the last four weeks.

Exclusion Criteria:

* Inability to understand Danish spoken or written and/or Trial procedures.
* Known or anticipated pregnancy (excluded by male sex, postmenopausal women, or otherwise negative U-HCG)
* Previous treatment with FMT
* Treatment with antibiotics within the past 6 weeks
* Changes in morphine treatment within the past 4 weeks
* Ongoing infection with Clostridioides difficile (negative PCR test)
* Known serious gastrointestinal disease or GI infection (diagnosed with e.g. inflammatory bowel disease and/or gastrointestinal cancer)
* Dysregulated thyroid disease (TSH) blood sample from previous consultations maximum 6 months old from
* Known intestinal stricture
* Planned MR scan within the study period
* Pacemaker/ICD
* Previous abdominal surgery (minor surgical procedures ex. appendectomy is allowed)
* Changes in medicine that affect the GI tract within the past four weeks.
* Known Severe end-organ disease

  * Lung disease with forced vital capacity(FVC)\<50% and/or diffusing lung capacity for carbon monoxide (DLCO) \<40%
  * Severe heart failure with ejection fraction \<30%
  * End-stage kidney disease with glomeration rate\<30ml/min
Physical Activity for Advanced Stage Cancer Patients

The purpose of this study is to understand if a home-based physical activity program can improve symptoms and physical function among patients with advanced stage cancer.

This program includes use of the Nintendo Wii Fit™Plus (Wii Fit) and home visits by a nurse. The same nurse will attend all of the visits.

Eligibility Criteria:
Inclusion Criteria:

* have stage III or IV cancer diagnosis
* able to understand English
* have a Karnofsky Performance Status (KPS) score of 60% (able to care for most of the personal needs)
* have fatigue and/or two other target symptoms
* have been cleared by their provider to engage low to moderate intensity physical activities

Exclusion Criteria:

* are hospitalized
* have lesion or metastasis of bone
* have a cardiac pacemaker
* have a history of seizure or loss of consciousness
* have been using a Wii Fit
* diagnosed cognitive impairment
Treatment of Bilateral Maxillofacial Post-traumatic Deformities

Combined application of surgery planning software and rapid prototyping technology and preshaped titanium plates can effectively promote the accuracy of the diagnosis and treatment of bilateral maxillofacial post traumatic deformities, reduce operation time and improve surgical effect.

All patients underwent preoperative CT scan. Firstly, SurgiCase were used to analyze CT data and design preliminary surgery plans. Secondly, three-dimensions resin skull models were produced by rapid prototyping technology. Model surgeries were performed to determine the location, reduction direction and shift distance of osteotomy. Based on the surgical simulation, the preliminary surgery plans were validated and optimized. Then, the titanium plates and mesh were preshaped on the models. Finally, according to the final surgery plans the operations were performed. The operation time, therapeutic effects and complications were observed. The follow-up periods were 1-12 months.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral maxillofacial Post-traumatic Deformities

Exclusion Criteria:

* unilateral maxillofacialPost-traumatic Deformities
Digital Delivery of Patient Education: A Case Study of Symptom Self-Management During Cancer Treatment

The increasing shift from face-to-face to online patient-clinician encounters in the healthcare system requires patients to be more involved in their medical care. This raises the urgent need to evaluate the extent to which proactive patients' self-care can be supported, particularly by informed telemedicine digital channels. Despite this imperative, research offering evidence-based instructional design of digital education remains surprisingly scarce. Embracing the framework of science education, which highlights the functional role of different knowledge types in educational processes, the current study seeks to evaluate an educational approach aimed at supporting cancer patients undergoing chemotherapy.

Cancer treatment serves as an exemplar health condition, demanding daily self-management from patients. The objectives of our research are as follows: (1) To delineate the types of knowledge required for effective symptom management, active participation in one's healthcare, and judicious decision-making regarding emergency room (ER) visits, with a focus on mechanistic knowledge pertaining to the rationale for treatment and procedural knowledge concerning the treatment regimen. (2) To appraise the impact of a digital learning environment in contrast to traditional methods on patients' acquisition of mechanistic and procedural knowledge. (3) To identify how patients engage with the digital patient education environment aiming to outline leaning patterns.

The investigators hypothesize that implementing digital education will enhance patients' understanding of both the 'why' (mechanistic) and 'how' (procedural) aspects of their treatment. Importantly, the investigators expect that mechanistic knowledge will be more impactful than procedural knowledge, leading to better symptom management and patient involvement, and ultimately reducing unnecessary visits to the ER.


Eligibility Criteria:
Inclusion Criteria:

* Gastrointestinal (GI) cancer patients
* Chemotherapy session within a specific round of treatment, with eligible treatments including FOLFOX, FOLFIRINOX, and FLOT.
* Hebrew speakers.

Exclusion Criteria:

* Impaired or degraded cognitive capabilities that may hinder effective learning.
* Individuals who discontinue their treatments due to terminal advancement of their disease or death.
Five Days Quadruple and Clarithromycin Containing Triple Therapy as Treatment for Helicobacter Pylori Eradication

The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.

Eligible patients with H pylori infection were randomized to receive either five-day QUAD (esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.) or EAC (esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d.). H. pylori status was rechecked by 13C urea breath test 8 weeks after treatment. Patients who failed their respective therapy were invited to undergo H. pylori susceptibility testing and crossover to receive the alternative regimen for the same duration.

Eligibility Criteria:
Inclusion Criteria:

* patients with H. pylori infection
* did not receive H. pylori eradication therapy before

Exclusion Criteria:

* patients who have received previous H. pylori eradication therapy
* co-morbidity of liver cirrhosis
* co-morbidity of renal failure
* co-morbidity of alcoholism
* co-morbidity of malignancy
* received antibiotics, bismuth preparations, proton pump inhibitors or probiotic in the preceding three months
* patients with known allergy to the medications used
* patients with a history of previous gastrointestinal diseases or gastric surgery
* pregnancy
Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?

To investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.

Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient will undergo randomization for a specific treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years of age
2. Medical history compatible with vestibular neuritis
3. Verification of vestibular neuritis with positive romberg test, pathological v-HIT and horizontal nystagmus with a rotatory component.

Exclusion Criteria:

1. Former medical history with vestibular dysfunction
2. Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
3. Onset of symptoms 14 days before recruitment to the study
4. Focal neurological symptoms/signs
5. Contraindication to prednisolone treatment
6. Problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.
Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)

The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Patients are invited to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy).

Exclusion Criteria:

* Patients with a history of hypersensitivity to temozolomide or dacarbazine.
* Pregnant women and women who may be pregnant.
Phage Safety Cohort Study

This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.

All potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the HCL pharmacovigilance center. In addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy
* Patient who did not object to participating in the study
* Patients ayant un poids minimum de 46kg

Exclusion Criteria:

* Patients under guardianship/curatorship
* Patients deprived of liberty
* Pregnant or breastfeeding women
Using RCT to Increase Completion Rates of the Health Assessment Questionnaire.

The proposed study aims to examine several iterations of instructions/reminders that patients receive for completing the Health Assessment Questionnaire (self-reported health outcomes) for their outpatient visit at NYU Langone Orthopedic Center. The goal is to increase the completion rates of patient-reported health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are eligible to receive the Health Assessment Questionnaire in preparation for and during their outpatient visit to the NYU Langone Orthopedic Center.

Exclusion Criteria:

* N/A
French Observatory of Familial Hypercholesterolemia in Cardiology

The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk.

The frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management.

Main objectives:

* Establish a monitoring patients with hypercholesterolemia Family cardiology in France
* Characterize the Family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* coronary patients
* who agreed to participate
* high LDL-c levels: \* LDL-c\> = 1.9g / l without lipid lowering treatment according to the diagnostic score of Family Hypercholesterolemia these coronary patients with LDL\> 1.9g / l may possibly or probably be achieved Hypercholesterolemia Family.

or

\* LDL-c\> = 1.6g / l in lipid-lowering treatment, the reduction of LDL-c average expected under standard lipid-lowering therapy (statin alone) being 30-40% of these patients had therefore pretreatment levels greater than 2 g / l or greater than 2.5 g / l and may possibly or probably be achieved Family Hypercholesterolemia after the diagnostic score.

Exclusion Criteria:

* Expressed refusal to participate in the observatory
* Age ≤ 18
LEADERS FREE II: BioFreedom™ Pivotal Study

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy

Eligibility Criteria:
Inclusion Criteria:

Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.

Reasons of unsuitability for \> 1 month dual antiplatelet treatment must include one or more of the following:

1. Adjunctive oral anticoagulation treatment planned to continue after PCI
2. Age ≥ 75 years old
3. Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)
4. Any prior intracerebral bleed
5. Any stroke in the last 12 months
6. Hospital admission for bleeding during the prior 12 months
7. Non skin cancer diagnosed or treated \< 3 years, with a perceived increased risk for bleeding
8. Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for \>30 days after PCI
9. Planned surgery that would require interruption of DAPT (within next 6 months)
10. Renal failure defined as: Creatinine clearance \<40 ml/min
11. Thrombocytopenia (PLT \<100,000/mm3)
12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
13. Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion Criteria:

1. Pregnant and breastfeeding women
2. Patients expected not to comply with 1 month DAPT
3. Patients requiring a planned staged PCI procedure more than one week after the index procedure
4. Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
5. Active bleeding at the time of inclusion
6. Reference vessel diameter \<2.25 - \>4.0mm
7. Cardiogenic shock
8. Compliance with long-term single anti-platelet therapy unlikely
9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
10. PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
11. Participation in another clinical trial (12 months after index procedure)
12. Patients with a life expectancy of \< 12 months
13. Patients under judicial protection, tutorship or curatorship (for France only)
Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis

This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.

This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). The study will include 21-45 participants randomly given active product or inactive product (placebo). Two (2) out of every three (3) participants enrolled will receive active product. The participants will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic sclerosis (scleroderma)
* At least one "active" digital ulcer
* Medication for systemic sclerosis unchanged for 30 days

Exclusion Criteria:

* Infection or gangrene in ulcer
* Citrus allergy
* Unstable heart, kidney, or liver disease
* Active infection of any type
* Current cancer treatment or uncured cancer
* Pregnancy or breast feeding
ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Clinical history of Persistent allergic Rhinitis (PER) requiring treatment known at least since 2 years.
* Positive skin prick test (wheal \> 3 mm larger than the diluent control) or Radio Allergo Sorbent Assay (RAST) (\>= 3.5 IU/ml) to House Dust Mite (HDM) and Parietaria (less than 1 year).
* Minimum mean Total 4 Symptom Score (T4SS) of 6 over baseline period.

Exclusion Criteria:

* Subjects currently treated by specific parietaria pollen immunotherapy
* Subjects suffering from non-allergic asthma
* Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids dependent asthma (severe asthma)
* Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids
Comparison of Two Different Procedures for Plexus Anesthesia

The purpose of this study is to investigate the influence of difference positioning on extension and efficacy of brachial plexus anesthesia at 20 minutes by using the axillary plexus block with supine positioning and a lateral positioning onto the non-anaesthetized side, combined with 20° Trendelenburg positioning.


Eligibility Criteria:
Inclusion Criteria:

* Single shot axillary block

Exclusion Criteria:

* Lateral position not possible
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants

Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of 5q-autosomal recessive SMA
* Negative blood pregnancy test at screening and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation
* For Part 1: Type 2 or 3 SMA ambulant or non-ambulant
* For Part 2: 1) Type 2 or 3 SMA non-ambulant; 2) RULM entry item A greater than or equal to 2; 3) ability to sit independently as assessed by item 9 of the MFM

Exclusion Criteria:

* Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening, or 5 half-lives of the drug, whichever is longer
* Concomitant or previous administration of a SMN2-targeting antisense oligonucleotide, SMN2 splicing modifier or gene therapy either in a clinical study or as part of medical care
* Any history of cell therapy
* Hospitalization for a pulmonary event within the last 2 months or planned at time of screening
* Surgery for scoliosis or hip fixation in the one year preceding screening or planned within the next 18 months
* Unstable gastrointestinal, renal, hepatic, endocrine, or cardiovascular system diseases as considered to be clinically significant by the Investigator
* Presence of clinically significant electrocardiogram abnormalities before study drug administration from average of triplicate measurement or cardiovascular disease indicating a safety risk for participants as determined by the Investigator
* Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration
* Recently initiated treatment (within less than \[\<\] 6 months prior to randomization) with oral salbutamol or another beta 2-adrenergic agonist taken orally
* Any prior use of chloroquine, hydroxychloroquine, retigabin, vigabatrin or thioridazine, is not allowed
* Ascertained or presumptive hypersensitivity (e.g., anaphylactic reaction) to Risdiplam or to the constituents of its formulation
* Recent history (less than one year) of ophthalmological diseases
* Participants requiring invasive ventilation or tracheostomy
Study Utilizing Rilonacept in Gout Exacerbations

This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 - 70 years of age
2. Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
5. Current presentation of acute gout flare in 3 joints or less

Exclusion Criteria:

1. Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit.
2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
3. History of NSAID intolerance
4. Participants with history of chronic, gouty arthritis