cyrilzakka/clinical-trials huggingface dataset:
Transcranial Vibrating System for Improving Vestibular Physical Therapy

This research study aims to determine whether low-frequency transcranial vibrations can act as a possible treatment for the dizziness and nausea often associated with vestibular physical therapy.

The purpose of this study is to determine the effectiveness of a Transcranial Vibration System (TCVS) at reducing the increased nausea and discomfort sometimes associated with vestibular physical therapy. The TCVS is a small device attached to an elastic band. It is worn around the head and produces vibrations. There is no implant or surgical procedure. The FDA has made a pre-determination that this is a low-risk device (a "Class 2 device" in FDA terminology).

The TCVS has previously been tested in healthy volunteers and has been found to safely and effectively decrease dizziness and nausea associated with vestibular discomfort. This study will expand that research to vestibular disorder patients who are undergoing physical therapy. The study compares the outcomes to not wearing a device, or to a control (inneffective) device.

Eligibility Criteria:
Inclusion Criteria:

* reluctant or unable to perform a full session of vestibular physical therapy

Exclusion Criteria:

* History of head injury within the last six months or currently suffering the effects of a head injury (i.e. concussion or traumatic brain injury)
* Presence of severe aphasia.
* History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia).
* Documented neurodegenerative disorders.
* Pregnancy Female candidates will be asked to take a pregnancy test first and will have to make a informed decision to participate based on the results of the pregnancy test.
* History of Cerebrovascular disorders.
* History of ear operation other than myringotomy and tube placement in the past.
* Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis.
the Efficacy and Safety of Curcuma Longa Extract Mixture on Immune Enhancement

This study was conducted to investigate the efficacy and safety of Curcuma longa extract mixture on immune enhancement

This study was 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Curcuma longa extract mixture on immune enhancement

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 19 and under 75 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who received influenza vaccination within 2 months before first intake of intervention
* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying severity.

Treatment options include lactulose administered orally or by nasogastric tube or enema, non-absorbable antibiotics, and protein-restricted diets.

Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective study at the 2008 American Association for the Study of Liver Diseases meeting showing clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.

Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying severity.

Hepatic encephalopathy is caused by accumulation of nitrogenous substances, primarily ammonia, in the blood. In advanced stages it is referred to as hepatic coma which may be preceded by seizures. The treatment goal is to reduce nitrogen load from the GI tract and to improve central nervous system (CNS) status.

Treatment options include lactulose administered orally or by nasogastric tube or enema, non-absorbable antibiotics, and protein-restricted diets.

Lactulose is nonabsorbable disaccharides that are currently used as first line agents for the treatment of HE. Its action is thought to beconversion to lactic acid and acetic acid resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable, and inhibits ammoniagenic coliform bacteria.

Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective study at the 2008 American Association for the Study of Liver Diseases meeting showing clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.

Mantry and colleagues showed that the number of hospitalizations and the duration of hospital stays were shortened for patients receiving combination therapy compared with those receiving lactulose monotherapy.

Eligibility Criteria:
Inclusion Criteria:

Age 18-70 years

Cirrhosis, defined by a combination of any of the following:

* Laboratory findings
* Endoscopic results
* Ultrasound
* Histology Overt hepatic encephalopathy

Exclusion Criteria:

* • Creatinine\>1.5 mg/dl

  * Alcohol use within prior 4 weeks
  * Non-hepatic metabolic encephalopathy
  * Hepatocellular carcinoma
  * Degenerative CNS disease
  * Any significant psychiatric illness or other medical comorbidity
Functional Genomics of Rare Genetic Diseases: Realization of Innovative Tools With High Diagnostic Power

The project aims to improve the understanding of a significant group of rare diseases both from a genetic/diagnostic and clinical/experimental point of view and aims to develop one or more diagnostic protocols.

The study will be conducted through the application of complementary experimental strategies, ranging from the clinical, genetic and molecular characterization of the pathology to the search for rare variants and the development of cellular disease models.

1. Clinical evaluation of patients and relatives
2. High throughput analysis of genetic variants in genome exomes
3. Genotype-phenotype association testing
4. Identification of genetic risk variants for rare diseases

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by: SLA, Incontinentia Pigmenti type II, Rett Syndrome, Paget Disease, Pompe Disease, Immunodeficiency, Centromeric instability and Facial anomalies, Cortical malformations and malignant epileptic encephalopathies

Exclusion Criteria:

* none
Hop Compounds on the Immune System in Overweight People

The aim of the present study is to determine the effect of Iso-alpha Acids and Xanthohumol from hops on the immune response in overweight participants.

The aim of the present study is to investigate whether the oral intake of Xanthohumol and Iso-alpha Acids has different protective effects on the immune response of isolated blood cells from overweight people with people with incipient metabolic diseases, what the time course of the effect is and whether the levels of the substances differ from normal-weight individuals.

After taking a fasting blood sample, the study participants receive one of the study drinks and a light breakfast. Both should be consumed within 15 minutes. Further blood samples are taken 1, 2, 3, 4 and 6 hours after the drinks have been consumed. To assess the effect of Xanthohumol and Iso-alpha Acids or a combination of both, clinical parameters, blood lipids, blood glucose, uric acid and inflammatory markers will be determined. Furthermore, blood cells, isolated from blood samples of each time point, will be stimulated for measuring inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25 - 29,9 kg/m²

as well as one or more of the following incipient metabolic diseases:

* pre-diabetes (fasting blood glucose 100-125 mg/dL),
* fatty liver (grade 1-3),
* high-normal blood pressure to mild hypertension (grade 1, systolic 140-159 mmHg)

Exclusion Criteria:

* History of diseases that could falsify the study results
* inflammatory bowel diseases
* malignant diseases of the gastrointestinal tract
* food allergies
* malabsorption
* kidney or liver disease (except simple fatty liver)
* symptomatic heart failure
* Taking medication to treat these diseases
* Consumption of special diets (e.g. vegan, gluten-free)
* Pregnancy
A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure

The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18
* 2. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
* 3. SARS CoV-2 laboratory positive obtained within 14 days of enrollment

Exclusion Criteria:

* 1. None
Dialogical Family Guidance PostDoc Study

This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Participants (families) experienced that they got information, guidance to ordinary life and that the DFG-therapists were listening to them and above all, helping with individual problems and questions. DFG include six meetings and professionals need to attend on a 3-day long education before using this intervention.

Previous studies have highlighted the need for families with a child with neurodevelopmental disorders, to get guidance to daily life, information and also professionals who allow parents to share their own experiences, feelings and questions. Dialogical Family Guidance is developed to offer target families (participants) the help mentioned above. This study is a postdoctoral study to achieve more knowledge and understanding about DFG intervention. This Postdoctoral study is focusing on DFG effectivity offered to families with young children (5-7years). Researchers also want to receive information about DFG effectivity between different units inside and outside the university hospital. Comparation between different units using DFG is one goal with this postdoc study. These results may give researchers deeper understanding when deciding where (university hospital och basic level units) and for whom (childrens age?) DFG intervention is giving the most optimal help.

Eligibility Criteria:
Inclusion Criteria:

* Families with a child with clinical diagnosis within neurodevelopmental ambrella (ADHD, Tourette, Autism disorder, OCD...).
* the child must be between 4-13 years.

Exclusion Criteria:

* Families who do not understand finnish language (because they can not fill the questionnaires and professionals offering DFG are all finnish speaking). At least one parent needs to talk finnish.
* Families who are not motivated to receive DFG.
* Families who do not have a child with neurodevelopmental disorders.
Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.

Spasticity is a common complication post stroke. Post-stroke spasticity along with weakness and lack of coordination result in gait abnormalities and functional limitations. Recent treatment option include neuromuscular electric stimulation (NMES), a form of therapy that applies electrical currents to produce contraction of innervated muscle by depolarizing local motor nerves. Currently, there are wide varieties of NMES devices available commercially for consumer.

The main purpose of this study is to evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke more than 6 months and to assess the impact of the program. This is single arm prospective intervention study. Patient will apply home-based NMES on their leg for 20 minutes, 5 days a week for 4 weeks. At the end of the study, an outcome measures will be assessed and patient will be required to answer a questionnaires on their experience.


Eligibility Criteria:
Inclusion Criteria:

1. Post stroke (hemorrhagic or ischemic) with ankle plantarflexor (gastrocnemius and soleus) spasticity MAS 1+ to MAS 3,
2. Post stroke more than 6 months,
3. At least 18 years old,
4. Able to ambulate 10 meter either independently or aided (single point stick or quadripod)
5. Compliant to outpatient therapy.
6. Minimal cognitive (MMSE\> 24) and minimal sensory impairment,
7. Stable neurological and medical condition

Exclusion Criteria:

1. Introduction or changes in anti-spastic medication dose within 3 months or during study period,
2. Receiving intervention for spasticity (eg BoNT or serial casting) within 3 months or during research period,
3. New neurological condition/disease,
4. Presence of contraindications to NMES, which is: Pregnancy, Malignancy, Presence of electronic implant eg cardiac pacemaker, cardioverter defibrillator, Uncontrolled seizure/epilepsy, Infected tissues/ tuberculosis or osteomyelitis, Impaired lower limb circulation/ DVT/ thrombophlebitis, Recent fracture or osteoporosis, Actively bleeding tissue or person with untreated hemorrhagic disorder, Damaged or skin diseases at the affected lower limb
Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally

The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.

This is an experimental treatment that will consist of receiving special white blood cell administrations either underneath the skin or in the lymph nodes. In this protocol, treatment will be given according to the "risk group". If there are certain abnormalities in the chromosomes, the disease is considered to be high risk. High-risk patients will first receive one cycle of chemotherapy with a regimen called DT PACE, after which the white blood cells will be collected. Leukapheresis is a procedure in which blood is removed, white blood cells are saved, and the remaining blood is given back to you. These dendritic cells will then be mixed with your individual myeloma protein and/or cells, and keyhole limpet hemocyanin (KLH) that is necessary for the enhancement of immune response against myeloma antigens. It is hoped that this will cause these cells to interact with and activate T cells, which will then destroy myeloma cells in your body. Half of these white cells will be injected into your lymph nodes (intranodally) and half will be given subcutaneously. High risk patients will receive a chemotherapy regimen called DT PACE.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have confirmed diagnosis of one of the following: Smoldering or indolent multiple myeloma, Multiple myeloma more than 1 year after autologous transplant and with stable disease, or Multiple myeloma with cytogenetic abnormalities
* Patients with secretory IgA or IgG must have purified idiotype protein available and/or tumor cells available, and patients with light chain or non-secretory myeloma must have tumor cells available
* Karnofsky performance score greater than or equal to 60
* ANC greater than or equal to 1,000/microliters, platelet count greater than or equal to 60,000/microliters, and CD4 count greater than or equal to 400/microliters.
* Expected survival of 3 months or more
* 18 years of age and older
* Have given a written consent and been informed about the investigational nature of the study.
* Negative serology for HIV, Hepatitis C, and negative for hepatitis B surface antigen

Exclusion Criteria:

* Patients with CD4 count \< 400/microliters, and/or with severely damaged immune functions
* Chemotherapy or other immunosuppressive treatment with steroids, cytoxan, methotrexate within 8 weeks
* Fever or active infection
* Liver function: total bilirubin greater than or equal to 2 x ULN or AST/ALT greater than or equal to 3 x ULN
* Renal function: Patients on dialysis
* Simultaneous treatment with a second investigational drug or biologic agent
The Role of Kinesiophobia in the Functional Recovery After Hip Replacement

Several authors explain as the kinesiophobia plays an important role for the recovery after orthopaedic surgery. The aim of the investigators study is to investigate if the kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure the fear level of movement. All the other variable that could influence the ILOA Score are identified and collected: age, sex, body max index, ability of patient pre-surgery, type of anesthesia, length of stay, pain, haemoglobin, possible complications.


Eligibility Criteria:
Inclusion Criteria:

* Primary hip joint replacement
* Clinical symptoms from more than 3 months

Exclusion Criteria:

* other orthopaedic surgery on the lower limb In the last year
* Not italian speaking
* Hip arthroplasty following fractures, revision surgery, and partial replacement
* Patients with concomitant neurologic (Parkinson, ictus), rheumatologic (rheumatoid arthritis) diseases,
* cognitive impaired.
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)

Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in response to Ziprasidone and in cognitive functioning as compared with OCD patients


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia and OCD for at least 6 months
* Minimum score of 14 on YBOCS
* Minimum score of 60 on PANSS
* Diagnosis of Schizophrenia without OC symptoms

Exclusion Criteria:

* Patients who are already being treated with ziprasidone
* Diagnosis of schizophreniform disorder
* Organic brain syndrome, mental retardation and pervasive developmental disorder
* Patients having any significantly cardiovascular illness or electrolyte imbalance
A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects

The purpose of the study is to evaluate the safety and tolerability of single ascending doses of UCB0107 administered by intravenous (iv) infusion in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male, \>= 18 and \<= 75 years of age
* Subject has a body mass index (BMI) \>= 18.0 and \< 30.0 kg/m\^2, with a body weight of at least 50 kg and maximum 100 kg
* Subject is in good physical and mental health
* Subject has clinical laboratory test results within the reference ranges of the laboratory
* Subject's electrocardiogram (ECG) is considered "normal," or "abnormal" but clinically non-significant (as interpreted by the investigator)
* Male subject confirms that, during the study period and for a period of 6 months or 5 half-lives of the investigational medicinal product (IMP) (whichever is longer), when having sexual intercourse with a woman of childbearing potential, a method of efficient contraception will be used, including a barrier AND an additional highly effective contraceptive method by the female partner

Exclusion Criteria:

* Subject is an employee or direct relative of an employee of the contract research organization (CRO) or UCB
* Subject has previously been assigned to treatment in this study or in another study of the medication under investigation in this study
* Subject is considered to be a vulnerable participant
* Subject has had major surgery (including joint surgery) within 6 months prior to Screening, or has planned surgery within 6 months after study treatment
* Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 4 weeks before the first dose of IMP
Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine

This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.


Eligibility Criteria:
Inclusion Criteria:

1. Female subjects between, and including, 18 and 45 years of age at the first vaccination;
2. Healthy subjects as established by medical history and history-oriented clinical examination;
3. Be able to understand and comply with the request of the protocol;
4. Without acute cervicitis;
5. Not pregnant;
6. Have intact cervix.

Exclusion Criteria:

1. Use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period;
2. Are using immunosuppressants;
3. Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period;
4. Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment;
5. Fever;
6. Concurrently participating another clinical trial;
7. Has received vaccines against HPV 16/18 ;
8. Immunodeficient;
9. History of allergic disease;
10. Serious medical disorders;
11. Blood coagulation disorders;
12. Epilepsy;
13. Unable to comply with protocol due to the mental illness;
14. Visible Condyloma;
15. Pregnant or breast-feeding women;
16. vergins;
17. Have more than 4 sexual partners.