cyrilzakka/clinical-trials huggingface dataset:
Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®

Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.

The aim of this randomized, controlled, double-blind, parallel, multicentric trial is to investigate wether the synbiotic food supplement Nagasin® can support the colonization resistance of the gut microbiota after disturbance by antimicrobial treatment.

The main question is whether Nagasin® can prevent any increase in abundance of C.difficile within the first four weeks after antimicrobial treatment for a C. difficile infection.

Participants will receive Nagasin® or the comparator as a food supplement during the first four weeks after antimicrobial treatment for a C. difficile episode.

Eligibility Criteria:
Inclusion Criteria:

* C. difficile infection (CDI) diagnosis
* antimicrobial treatment (e.g. metronidazole, vancomycin or fidaxomicin) for C. difficile infection at ICF
* Written informed consent by the participant after information about the research project

Exclusion Criteria:

* total parenteral nutrition
* insulin-dependent (type 1) diabetes
* severe disease defined as any of the following:

  * White blood cell count (WBC) \> 30,000 or \< 1000 cells/mm3
  * Neutropenia \< 500 x 10\^9 per liter
  * Intensive care unit (ICU) patient at time C. difficile infection diagnosed
  * In case no hematology values are available, presence of severe can be evaluated by the local principal investigator or his designee
* is severely immunocompromised as defined by any of the following:

  * active malignancy receiving severe immunosuppressive chemotherapy with subsequent leukopenia (as defined above)
  * long-term systemic steroid therapy ≥ 30 mg / d
  * recipients of stem cell transfer (≤ 12 months)
  * severe inborn immune deficiency or severe immunosuppressive therapy as evaluated by the investigator
  * HIV patients with low CD4+ cell count (\< 200 x 10\^9 per liter)
  * Inflammatory bowel disease patients if:
  * severe ulcerative colitis (classified as endoscopic Mayo = 3 (max. 30 days old) or as evaluated by investigator)
  * Severe Crohn's disease with acute penetrating complication (abscess and/or actively draining fistulae) or as evaluated by investigator
  * Liver cirrhosis (classified as Child C) with clinically significant portal hypertension and/or low thrombocyte count (20 × 10\^9 per liter)
* Acute pancreatitis
* prosthetic heart valves or endocarditis
* consumption of other high-dose (\>10\^10 cfu/dose) probiotic products during the study period.
* Inability to understand and follow study procedures
* prosthetic heart valves or endocarditis
* consumption of other high-dose (\>10\^10 cfu/dose) probiotic products during the study period.
* Inability to understand and follow study procedures
Evaluation of the Skin-Beautifying Effects of Collagen Drinks

This study aims to investigate the skin beauty benefits of collagen drinks in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years
2. Healthy people

Exclusion Criteria:

1. Non-volunteer
2. Pregnant and lactating women
3. Hypersensitivity to the assigned product
4. Diagnosed with skin diseases, liver diseases, kinedy disease, and other severe diseases
5. Cosmetic, drug, or food allergies
6. Concurrent aesthetic treatments (e.g., intense pulse light, medical peelings, or laser therapy)
7. Aceepted aesthetic treatments one month ago before the study
8. Chronic sun exposure (over 3 hours/day)
9. The members of the research team
Does Transcranial Magnetic Stimulation of the Cingulate Cortex Modulate the Perception of Dyspnoea?

The treatment we are studying is Transcranial Magnetic Stimulation (TMS). In TMS, an electromagnetic pulse is passed into the brain through a coil placed on the head. Previous studies have shown TMS to be capable of altering brain activity in specific areas; for example it has been used to improve mood in clinical depression. In this study we will assess if, by targeting TMS to the brain area responsible for feeling breathless, participants' breathlessness will be improved

This protocol describes an exploratory crossover pilot study to assess whether targeted repetitive pulse Transcranial Magnetic Stimulation (TMS) i.e. targeted at the anterior cingulate cortex (ACC), affords relief of 'air hunger' in patients with breathlessness refractory to maximal medical therapy, compared to 'control' TMS directed at a remote site independent of the area of interest (within the lateral right parietal region of the brain).

12 right-handed patients suffering from refractory dyspnoea will receive pulses of targeted TMS or control TMS (crossover design), in a random order. The order will be random and use a minimisation procedure for baseline dyspnoea severity and sex. Repetitive targeted TMS (or control) pulses at 110% motor threshold at a frequency of 1Hz will be given for a 15 minute period1.

On a second, later, day the same subjects will perform the same protocol after receiving inhaled menthol or control (normal, non odorous air), in random order.

Outcomes will be assessed during the 10 minutes after targeted TMS/control TMS during which post stimulation inhibition of neural activity is expected.

Eligibility Criteria:
Inclusion Criteria:

1. Refractory dyspnoea (persisting sensation of air hunger despite optimisation of medical treatment)
2. Histocytologically proven thoracic malignancy
3. Written informed consent

Exclusion Criteria:

1. Age \<18 years
2. Left-handed
3. Structural brain disease (including cerebral metastasis)
4. Personal or family history of seizures
5. Implantable metallic objects e.g. a pacemaker, or other contraindication to transcranial magnetic stimulation
6. Pregnant or breast feeding
7. Previous electroconvulsive therapy (ECT)
8. Poor mobility
9. Visual impairment
10. Lack of social support / home to go to after the study treatment
11. Alcohol dependency
12. PaCO2 \>6kPa at rest
13. Inability to provide informed consent
Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients

The aim of this study is to determine the time to TOF ≥ 0.9 after either neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg in patients with age ≥ 75 years. The hypothesis of this study is that sugammadex 2 mg/kg provides a faster time to TOF ≥ 0.9 compared to neostigmine/glycopyrrolate 50 mikrogr/kg.

Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications.

Although the use of neuromuscular blocking agents (NMBAs) to improve surgical condition are still debated, they are routinely administered in the clinical setting during anesthesia both to facilitate tracheal intubation and impair the surgical conditions. However, elderly patients administered NMBAs during anesthesia have an increased risk of postoperative residual neuromuscular block which is associated with more frequent episodes of hypoxemia, postoperative pulmonary complications, discomfort and longer hospital length of stay.

To prevent postoperative residual block it is strongly recommended to employ neuromuscular monitoring perioperatively, performed by train-of-four (TOF) stimulation, which enables the anesthetist to titrate the depth of block and to reverse the block if spontaneous recovery has not occurred upon conclusion of surgery.

It is possible to reverse rocuronium induced neuromuscular blockade with either neostigmine/glycopyrrolate (an acetylcholine esterase inhibitor) or sugammadex (a modified cyclodextrin). However, the optimal choice of reversal agent for rocuronium induced neuromuscular blockade in elderly patients is unknown. There is a need for studies investigating which reversal agent is optimal in elderly patients.

This randomized, parallel group trial will compare neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg for reversal of rocuronium induced blockade in elderly patients (≥ 75 years) undergoing robot surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 75 years old
2. Informed consent
3. Scheduled for robotic assisted laparoscopic surgery under general anesthesia with intubation and use of rocuronium during the entire operation
4. American Society of Anesthesiologists (ASA) physical status classification I to IV
5. Can read and understand Danish

Exclusion Criteria:

1. Known allergy to rocuronium, sugammadex or neostigmine/glycopyrrolate
2. Neuromuscular disease that may interfere with neuromuscular data
3. Severe renal impairment defined as eGFR \< 30 ml/min
4. Indication for rapid sequence induction
5. Known intestinal or ureter obstruction
6. Known peritonitis
Intrauterine Insemination With Letrozole Versus in Natural Cycle

Rationale: Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, investigators found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. Investigators therefore perform a randomized clinical trial (RCT) on the subject in the Centre of Reproductive Medicine, Peking University Third Hospital, Beijing, China.

Objective: To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment.

Study design Randomized clinical trial.

Study population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI.

Intervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3-5 for 5 days. Investigators will treat the couples for 3 cycles, with a time horizon of 4 months.

Main study parameters/endpoints Primary outcome is ongoing pregnancy leading to live birth. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications and patients' costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future subfertile couples.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with unexplained or mild male subfertility
* At least one sided tubal patency, established according to local protocol
* Normal or mild impairment of semen quality defined as a TMSC of 3 million or more based on at least one semen analysis

Exclusion Criteria:

* Woman with double sided tubal pathology
* Women with irregular cycles, PCOS or other endocrine disorders
* Impaired semen quality: pre-wash TMSC \<3 million.
Acute Exposure to High Altitude on Heart Rate and Ventilation During Exercise

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (Säntis; 2500m above sea level) on heart rate and Ventilation changes under exercise.

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure to High Altitude (2500m) and Low Altitude (Zurich; 470m) of up to 5 hours, the participants' heart rate and Ventilation will be compared under exercise.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)

The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.


Eligibility Criteria:
Inclusion Criteria:

* Age 10 and older
* Documented diagnosis of HAE, Type I or II
* Executed informed consent
* Presentation for treatment within 8 hours of patient recognition of moderate to severe HAE attack

Exclusion Criteria:

* Receipt of investigational drug or device, other than DX-88, within 30 days of treatment
* Receipt of non-investigational C1-INH (C1 esterase inhibitor) within 7 days of treatment
* Diagnostic of acquired angioedema, estrogen-dependent angioedema or drug induced angioedema
* Pregnancy or breastfeeding
* Patients who have received DX-88 within 7 days of presentation for dosing in the Double-blind Phase
A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)

The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either indolent (iNHL) or aggressive (aNHL).

It is an open label dose escalating study in phase I and open label in phase II, but the two doses in iNHL \& aNHL are randomized (to high or low dose of the same open label treatment). CLL was not randomized as only one dose level was used.

Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>=18 years of age;
* Phase 1 only: CD20+ malignant disease (B-cell lymphoma or B-CLL);
* Phase 2 only: relapsed or refractory indolent NHL, relapsed or refractory aggressive NHL or relapsed or refractory B-CLL
* Have a clinical indication for treatment as determined by the investigator
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy \>12 weeks

Exclusion Criteria:

* Prior use of any investigational antibody therapy or other agent within 6 months of study start;
* Prior use of any anti-cancer vaccine;
* Prior use of standard anti-lymphoma/leukemia therapy or radiation therapy within 4 weeks of enrollment;
* Prior use of MabThera (rituximab) within 8 weeks of study entry;
* Prior administration of radioimmunotherapy 3 months prior to study entry;
* Central nervous system (CNS) lymphoma.
Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction

OBJECTIVES:

I. Evaluate whether vestibular rehabilitation training is of value in reducing anxiety symptoms in patients with panic disorder with or without agoraphobia who have vestibular dysfunction as identified by clinical vestibular tests.

PROTOCOL OUTLINE: During the first 4 weeks of study, patients meet with a clinical nurse specialist once a week for approximately 1 hour. During this time, the nature of the anxiety disorder is explained and exposure to previously feared situations is encouraged.

Only patients who remain symptomatic at a stable level following self-exposure will proceed with rehabilitation training.

Patients meet with a physical therapist once a week for 4 weeks to further evaluate the extent of problems associated with balance. Then, patients undergo weekly 1 hour exercises for 8 weeks with the physical therapist, focusing on sensation, head and eye coordination, movement with eyes opened and closed, and gait.

Concurrently, patients meet with the clinical nurse specialist every 4 weeks during and after physical therapy to evaluate the effects of vestibular treatment on anxiety symptoms.

Training is continued if patient is symptomatic; otherwise, patient is discharged from study.

Eligibility Criteria:
* Diagnosed panic disorder with or without agoraphobia
* Vestibular dysfunction, as defined by abnormalities in the caloric and/or rotational tests
* Continued symptomatology after general instructions of the importance of exposure to feared situations
* Absence of acute symptoms of anxiety or depression assessed to need immediate clinical care
Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis

The purpose of this study is to assess the pharmacokinetic parameters and safety of topical MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use conditions.

This is a multi-center, open-label study to assess the degree of systemic exposure and safety of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in pediatric subjects with atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 2 to \<18 years of age
* Diagnosis of atopic dermatitis (AD)
* AD affecting ≥ 35% body surface area (BSA) if 2 to \< 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas)

Exclusion Criteria:

* Active or acute viral skin infection
* History of recurrent bacterial infection
* Malignancy
* Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments
Human Genomic Population Structure and Phenotype-genotype Variation in ADME Genes in Four Populations

Physicians know that their patients can react differently to the same medical treatment: for some of them, the drug will prove inefficient, whereas for others it might provoke side-effects, sometimes rather serious. Such differences in response to drug intake are due to several factors, of which molecular variations in specific genes, named " ADME " (Absorption, Distribution, Metabolism, Excretion). This project aims at investigating the evolutionary mechanisms responsible for the diversity of ADME genes in human populations. Because of their role at the interface between the organism and its chemical environment, ADME genes are likely targets of recent selective pressures linked to changes in the environments in which humans evolved, such as changes in dietary habits for instance.

The aim of this project is to study the diversity of ADME genes and of their expression in five populations located along a latitudinal axis that extends from East Africa to Central Europe, passing through the Arabian Peninsula and the Mediterranean area, so as to take into account environmental factors that might have influenced the evolution of this diversity. This project is thus intended to evidence the evolutionary mechanisms that shaped genomic regions that are functionally important from the clinical and epidemiological point of view. Moreover, it will allow us to extend the knowledge of human molecular diversity and its evolution to a key-region of the peopling history of our species.


Eligibility Criteria:
Inclusion Criteria:

* Women and men in good health
* Aged between 18 and 50 years
* Students or staff in the Academic Institutions where sampling will take place
* With the 2 parents and four grand-parents born to the population;
* Able to provide informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women; or women that consider that being pregnant is a possibility;
* Allergic to one of the compounds included in micrococktail (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Dextromethorphan, Midazolam, and Fexofenadine);
* Pedigree related to another volunteer participant (siblings, cousins, uncles/aunts, nephews, etc.);
Hot AXIOS System Japan Post Market Survey

To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Patient who received implant procedure using study device at Japanese site.

Exclusion Criteria:

* NA
Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation in Spinal Cord Injury Patients

Comparison of different types of transcranial magnetic stimulation techniques which are intermittent theta burst stimulation (iTBS) and high frequency repetitive transcranial magnetic stimulation (rTMS) in patients with spinal cord injury

iTBS lasts shorter than rTMS so that this technique comfortable than rTMS for both patients and also physicians. Aim of this study is to compare effectiveness of this techniques. If results are same, iTBS can be used instead of rTMS.

Eligibility Criteria:
Inclusion Criteria:

* Incomplete spinal cord injury (ASIA C and D)
* 12 months after spinal cord injury
* At least 10 meters walking independent or with canadian, walker or walking stick
* Put signature to approved form

Exclusion Criteria:

* Epileptic seizure
* Pacemaker
* Pregnancy
* Neurological disease different from spinal cord injury
* Metalic implant in brain or scalp
* Brain surgery
* Orthopedic problem in lower extremity
* Malignity