cyrilzakka/clinical-trials huggingface dataset:
Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

The purpose of this study is to determine if intravenous micronutrient therapy (IVMT) is effective in the treatment of fibromyalgia, as assessed by validated functional and pain measures.

As per Brief Summary

Eligibility Criteria:
Inclusion criteria:

* Meet the American College of Rheumatology criteria for Fibromyalgia diagnosis;
* On no medication for Fibromyalgia other than acetaminophen, or willing to stop all such medication for the duration of the study

  * Willing to stop all FMS medication for the duration of the study or be on a stable dose of such medication for at least 3 months

Exclusion criteria:

* Other concurrent medical conditions such as rheumatologic disease, chronic infection, untreated endocrine disorders, unstable seizures, psychiatric disorders, acute peptic ulcer disease, congestive heart failure, chronic liver disorders and/or bleeding problems

  * Allergy to thiamin
* Unwilling to stop vitamin supplementation for the duration of the study

  * PLEASE NOTE: Travel to and accomodations at the study site can NOT be compensated. Anyone wishing to travel from outside of the study site's geographic area must do so at their own risk and expense.
Giardia Induced Fatigue and Functional Gastrointestinal Diseases

A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research questions of national and global importance:

* Studying the pathoimmunology of giardiasis in a natural setting, and following the genetic and immunological responses leading to recovery or persistent disease and sequelae.
* Studying the two disease entities FGID and CFS when induced by acute giardiasi and their risk factors.
* Interventional cognitive behavioural therapy is the only intervention documented to have significant effect on CFS outcome, and conventional cognitive behavioural therapy will be compared to a psycho-educational programme in the format of a randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Problems with fatigue of any severity after Giardia infection
Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance

Prospective observational study with the primary objective is to assess technical competence in anaesthesiology specialists who perform bronchoscopic endotracheal intubation through a supraglottic airway device (SAD), by using a global rating assessment scale (GRS) and a procedure checklist. We will use an Objective Structured Assessment of Technical Skills (OSATS)-inspired GRS that previously have been validated for fiberoptic intubation and a novel clinical checklist developed for the procedure. Secondarily, we will examine potential predictor variables.

This study is a preplanned prospective observational substudy of a randomised controlled trial (RCT) with the primary aim to compare time to intubation when using two different supraglottic airway devices (SAD) as conduit for bronchoscopic intubation: the Ambu® AuraGain LMA as compared to the i-gel LMA (reference: I-gel vs AuraGain for Bronchoscopic Intubation Through SGA (ClinicalTrials.gov Identifier: NCT04680169)).

We will include all physicians who provide the airway management in the RCT.

The primary objective is to assess technical competence/performance by using a global rating assessment scale (GRS) and a procedure checklist. We will use an Objective Structured Assessment of Technical Skills (OSATS)-inspired GRS that previously have been validated for fiberoptic intubation and a novel clinical checklist developed for the procedure. Secondarily, we will examine potential predictor variables in multivariate analyses

Airway management will be video recorded. Two anaesthesiologists specialists (assessors), not otherwise involved in the trial and not employed at the hospital, will watch the video recordings of each case of airway management, i.e., the complete airway management provided by a responsible physician participant for each of the included patient participants.

For each case of airway management, they will access the physician's technical performance during the attempt to perform bronchoscopic endotracheal intubation through a SAD.

Assessors will complete a checklist during the procedure. Each item is dichotomously evaluated: done correctly (score=1)/done incorrectly or not performed (score=0). The checklist score represents the sum score for the 30 items (potential sum score range 0-30).

Assessors will evaluate the physician's technical performance using a validated GRS, scored from 8 to 40, for each case of airway management. The GRS is based on 8 items. Each item is scored from one (poor) to five (superior). A score of three is considered 'competent' for each item. The GRS score represent the sum score for all items.

Eligibility Criteria:
Inclusion Criteria:

* Anaesthetist specialists performing bronchoskopic tracheal intubation through a supraglottic airway device
* The supraglottic airway device is either i-gelTM or a Ambu® AuraGainTM (4 in total, 2 of each i random order).

Exclusion Criteria:

* Refuse to participate
* Any other involvement in the research project
Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Thirty patients will be treated using the principles of guided bone regeneration and ridge preservation. Fifteen test patients will receive the flapless technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. The positive control group of fifteen patients will receive the flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Eligibility Criteria:
Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Previous head and neck radiation therapy.
7. Chemotherapy in the previous 12 months.
8. Pregnant patients.
Evaluate the Frequency of Fatigue After Cerebral Infarction

Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the cerebral infarction may have an impact on this fatigue.

The aim of this research was to study the frequency of fatigue after cerebral infarction, the associated factors, in particular the impact of treatments administered in the acute phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting recent symptomatic cerebral infarction (\< 1 week) defined according to World Health Organization (WHO) criteria and hospitalised at the Stroke Unit in Dijon University.
* Patients aged 18 years or older.
* Patients who have been informed about the study, or their person of trust for patients unable to express their consent.

Exclusion Criteria:

* Patients (or their person of trust) who refuse to participate in the study.
* Subjects in custody.
* Patients presenting prior co-morbidity as a cause of significant fatigue in the opinion of the investigator
* Patients with dementia or aphasia before the stroke
* Patients (or their person of trust) who may be difficult to contact by telephone during the follow-up.
A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy

The purpose of this study is to investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers, and bone density (the amount of mineral per square centimeter of bone ) in female participants with epilepsy (seizure disorder), before menopause (time in life when a woman stops having a menstrual period), as compared with healthy participants and comparative group received either carbamazepine or valproic acid monotherapy for at least last one year.

This is a cross-sectional (observations or measurements made at a single point in time, usually at participant enrollment), multi-center (conducted in more than one center), and comparative study of topiramate monotherapy in female participants with epilepsy. Female participants must have received either topiramate, carbamazepine, or valproic acid monotherapy for more than one year for the treatment of epilepsy. Blood samples will be obtained from fasting participants to investigate the effect of study drug on the bone and mineral metabolism markers, and bone density compared to healthy participants and comparative group (carbamazepine and valproic acid monotherapy). Bone mineral density will be measured from the participants' lumbar spine or femur. A survey of food intake and physical activity for the participants will be performed using a standardized validated detailed questionnaire. The post-study visit (or follow up phone contact) will be performed for the occurrence of serious adverse events (SAE) for safety evaluation. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who agree to participate in this study
* Female epileptic participants
* Participants who are receiving topiramate, carbamazepine or valproic acid monotherapy for more than one year
* Participants who are using proper contraceptive method (s) or have a negative pregnancy test result

Exclusion Criteria:

* Participants with a motor function disorder
* Participants with a disease which affects their skeleton including primary hyperparathyroidism, Paget's disease, multiple myeloma, liver and kidney disorder, thyroid disease, malabsorption disorder, diabetes, and malignancies
* Participants who have taken within last one year, or are currently taking a drug which affects the bone and mineral metabolism such as vitamin D, calcium, anabolic steroids, bisphosphonates, calcitonin, glucocorticoids, and diuretics
* Voluntary or surgical postmenopausal participants
* Participants with amenorrhea for more than 6 months
Dynamic Internal Fixation of Femoral Neck Fractures

Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures. Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.

Two implant systems are mainly used for internal fixation: canulated screws and plate-screw-systems. Regarding the latter, the dynamic hip screw systems (DHS)represent the most frequently used devices.

Targon FN (Aesculap) is a new plate-screw system and available on the market since 2007. In contrast to the DHS, which uses only one telescrew, the Targon FN provides up to four telescrews.

With this registry, we want to evaluate the results of Targon FN compared with DHS systems.

Eligibility Criteria:
Inclusion Criteria:

* men \>= 60 years, women \>= 55 years
* femoral neck fractures needing surgical therapy
* femoral head preserving indication
* Living in a 100 km Radius from Hospital

Exclusion Criteria:

* Patient not able to walk
* Previous fracture or surgery on ipsilateral hip
* pathological fracture
* open fracture
Acupuncture in Infantile Colic

The purpose of this study is to investigate whether acupuncture influences:

* the rate of infants who still fulfil the colic criterion after three intervention weeks
* the time when the infants are crying, fussing or have intense bouts of colicky symptoms

Infantile colic is a common problem. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no known treatment that is both effective and harmless. Acupuncture releases different neurotransmitters and hormones, gives pain reduction and affects digestion. Acupuncture in infantile colic has not been studied in a scientific way even though the method is used in many countries. In this randomised study we will investigate if acupuncture affects symptoms in infantile colic.

Eligibility Criteria:
Inclusion Criteria:

* 2-8 weeks old otherwise healthy infants who are fussing/crying more than three hours/day, more than three days during one week

Exclusion Criteria:

* infants born before week 36
* infants who dont gain weight properly
* infants taking other medicine than dimethicone or lactobacillus reuteri
Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy

This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient has stage II-III ER/PR less than or equal to 10% HER2 negative by FISH and/or IHC breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to RCB II or III) disease.
* Patient has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome sequencing.
* Patient is 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Patients must have adequate organ and marrow function.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Patients without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and/or radiotherapy (whichever is later) for the purposes of study enrollment.
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with known active locally advanced unresectable or metastatic cancer.
* Patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the Principal Investigator (PI).
* Patients who have a medical issue in the opinion of the treating physician and/or PI that would make them unsuitable for pheresis.
* Patients who are currently receiving any other investigational agents.
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study.
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1

A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-75 years;
2. The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 1.0xULN \< ALT ≤ 3.0xULN or 1.0xULN \< AST ≤ 3.0xULN or 1.0xULN \< IgG ≤ 1.3xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
3. Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of cirrhosis;
3. Patients with presence of fulminant liver failure;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease;
5. Pregnant and breeding women and women of childbearing age in need of reproduction;
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Parenteral administration of blood or blood products within 6 months before screening;
8. Recent treatment with drugs having known liver toxicity;
9. Taken part in other clinic trials within 6 months before enrollment.
The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood

1. To study the influence of antenatal classes for first time parents and their effect ob pregnancy, birth and parenthood.
2. Randomized into two groups (a. 3 courses in midpregnancy and b. no courses)
3. Data on pregnancy, birth and parenthood are collected from register and questionaire

Data collected contain register data and data from questionnaire, which also contains psychometric tests

Eligibility Criteria:
Inclusion Criteria:

Pregnant Over 18 years of age Singleton

Exclusion Criteria:
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients who met severity classification III.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
* Patients who cannot take at least one action of eating a meal, excreting, or moving with oneself alone, and need assistance in everyday life.
* Patients whose progress of the condition during 12 weeks before administration meet other requirements.

Exclusion Criteria:

* Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, sever heart disease, sever renal disease and so on, or they need to be administered antibiotics to infection.
* Patients who complain the difficulty in breathing caused by deteriorating the respiratory function.
* Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
* Patients who have been administered other investigational products within 12 weeks before consent, or who are participating in other clinical trials at present.
* In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
The Effect of Motivational Interviewing on Ethical Decision Making and Moral Distress

The purpose of this study is a pre-test-post-test, randomized controlled experimental study with a control group, planned to examine the effect of motivational interviewing on ethical decision-making and moral distress levels in intensive care nurses.

The research was designed individually. The research will be conducted between 30 JANUARY 2025 and 27 FEBRUARY 2025, with Certificates working in the intensive care units of the Cumhuriyet University Faculty of Medicine in Sivas-Central province of Turkey and meeting the included criteria. The study will be carried out face to face after obtaining the necessary institutional permissions. At each stage of the research, the quantities will be taken into consideration, taking into account the inclusion criteria. They will be asked to fill out informed consent forms asking to explain the subject, purpose and method of receiving the study. Participants will be divided into intervention and control groups by simple randomization method. Participant Information Form, Ethical Dilemma Test in Nursing and Moral Distress Scale will be applied to both groups before the intervention. Data collection tools will be applied to the control group simultaneously with the intervention group. The picture of the implementation of the study will be recorded by the hospital management where appropriate and will be carried out in a private area. At the end of the intervention program, the Nursing Ethical Dilemma Test and Moral Distress Scale will be administered to both groups.

Eligibility Criteria:
Inclusion Criteria:

* Nurses working in Intensive Care Clinics who volunteer to participate in the study will be included.

Exclusion Criteria:

* Being diagnosed with any mental illness
Different Dietary Patterns

The aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 kg/m² und 24.9 kg/m²

Exclusion Criteria:

* Chronic inflammatory diseases
* Metabolic diseases
* Viral or bacterial infections in the last 3 weeks
* Allergic reactions in the last 3 weeks
* Intake of anti-inflammatory drugs
* Malignant diseases
* Pregnancy and lactation
* Smoking
* Alcohol consumption \> 10 g/d for women and \> 20 g/d for men
* Drug consumption
* Vegetarian or vegan diet
* Food intolerances
Irritable Bowel Syndrome and Food Sensitivity

The primary objective of the clinical trial portion of this study is to assess whether an individualized dietary plan based on a commercial food sensitivity assay provides specific benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).

This is a parallel group, randomized control trial, powered to assess changes in validated outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments will occur at baseline, 4-weeks, and 8-weeks post-baseline.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-70 years of age.
* Irritable Bowel Syndrome by Rome III criteria.
* Stable dose (30 days) of concurrent IBS medications
* Agree not to make significant changes to their diet during the study
* IBS-SSS score of \>150

Exclusion Criteria:

* History of major abdominal surgeries
* History of inflammatory bowel disease
* Antibiotic use within 1 month of enrollment
* Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function
* Current use of opioid pain medications (except for NSAIDs)
* Previous experience participating in dietary studies for IBS
* Current use of medications which are known to be affected by modest dietary changes
* Vitamin C use of \>2000 mg/day
* Quercetin use of \>500 mg/day