cyrilzakka/clinical-trials huggingface dataset:
Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees

The purpose of this study is to determine if subthreshold vibration, when applied to the residual limb of a lower limb amputee through their prosthetic socket, can sufficiently enhance peripheral sensation to result in an improved ability to balance and walk.

One of the many complications of diabetes is the loss of sensation in the feet. This sensory deficit can negatively impact the postural stability and mobility of non-amputees, since without feedback, it is simply more difficult to stand and walk. For lower limb amputees, the problem is compounded. These patients often have difficulty with prosthetic limb placement during maneuvering tasks, exhibit dramatic increases in the movement of their center of pressure during quiet standing, and both clinical and observational gait analysis reveal significant changes in their gait pattern relative to non-amputees.

The investigators' work proposes to explore the use of a novel prosthetic intervention for diabetic lower limb amputees. The investigators hypothesize that the intervention will sufficiently enhance proprioception to result in measurably improved postural stability and locomotor function for these patients. The intervention is based on a phenomenon known as stochastic resonance, whereby the application of sub-threshold vibration enables mechano-receptors previously unable to respond to stimuli to become more susceptible to depolarization. For Veterans with neuropathic proprioceptive losses, stochastic resonance may facilitate a functional response from subtle stimuli where gross inputs were formerly required.

Eligibility Criteria:
Inclusion Criteria:

Amputee subjects:

* unilateral transtibial amputee of diabetic etiology,
* have been fit with a prosthesis and have used a prosthesis for at least one year,
* wear the prosthesis at least 4 hours per day,
* ambulate without upper extremity aids,
* have no history of injurious falls within the previous six months, and
* touch sensation measured by a 10 gauge Semmes-Weinstein Monofilament in the dermatomes of their residual limb.

Exclusion Criteria:

Subjects will be excluded if:

* they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics,
* their residual limb is ulcerated, or
* are currently using anticonvulsant medications for the treatment of neuropathic pain.
Transdiagnostic Internet Intervention to Improve Mental Health Among University Students

This study offers transdiagnostic CBT-based treatment for symptoms of depression and anxiety to university students who have previously responded to the WHO-WMH-ICS survey.


Eligibility Criteria:
Inclusion Criteria:

* PHQ-9 cutoff for mild depression
* GAD-7 cutoff for mild anxiety

Exclusion Criteria:

* Suicidal ideation or plans
* Severe levels of mental ill-health
Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of glycyrrhetinic acid combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients. One part of the participants are randomly selected to receive glycyrrhetinic acid (given compound glycyrrhizin tablets orally at a dose of 225mg per day for 1 month), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of glycyrrhetinic acid combining with high-dose dexamethasone therapy for the treatment of adults with ITP.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for immune thrombocytopenia;
* Untreated hospitalized patients, may be male or female, between the ages of 18\~ 80 years;
* To show a platelet count \<30 \* 10\^9/L, and with bleeding manifestations;
* Willing and able to sign written informed consent

Exclusion Criteria:

* Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit;
* Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit;
* Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study;
* Current HIV infection;
* Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac
* Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period;
* Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
* Patients who are deemed unsuitable for the study by the investigator.
Sweat Sensors for Athletic Performance

Pilot study of a soft, flexible wearable sweat sensor

Assessment of safety, and preliminary accuracy of a sweat sensor capable of operating underwater.

Eligibility Criteria:
Inclusion Criteria:

* No history of medical or surgical problems
* Age \>18 years old
* Subjects willing and able to comply with requirements of the protocol

Exclusion Criteria:

* Age \<18 years old
* Subjects unwilling and able to comply with requirements of the protocol
* History of skin allergy to medical adhesive tape
Accuracy of Rib Palpation for Dry Needling of Deep Periscapular Musculature, Measured With Ultrasound

Ultrasound was used to identify the location of a rib. This was compared to a practitioner's ability to palpate the area.

Ultrasound was used to identify the location of a rib. This was compared to a practitioner's ability to palpate the area. The purpose of this study is to identify if practitioners are as accurate as they think they are in identifying ribs. This is important, as mis-identifying a rib may put patients at risk for inadvertent needle entry into the lung.

Eligibility Criteria:
Inclusion Criteria:

* Anyone with ribs

Exclusion Criteria:

* No children
Endometrial Evaluation in Cases of Postmenopausal Bleeding

The aim of this prospective observational study is to evaluate abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy

Postmenopausal bleeding (PMB) is defined as vaginal bleeding occurring after twelve months of amenorrhoea, in a woman of the age where the menopause can be expected. Hence it does not apply to a young woman, who has had amenorrhoea from anorexia nervosa, or a pregnancy followed by lactation. However, it can apply to younger women following premature ovarian failure or premature menopause, Postmenopausal bleeding is a common problem representing 5% of all gynaecology outpatient attendances. postmenopausal bleeding is usually the first symptom of endometrial cancer and active intervention can lead to its early detection. So, there is need of a diagnostic tool with high accuracy for detection of endometrial pathology in most efficient and least invasive method possible.

Endometrial sampling is the gold standard for diagnosing abnormalities in the endometrial tissues ,however . There is a growing trend to use noninvasive procedures such as TVS, to measure the endometrial thickness, diagnose adenomyosis, endometrial polyps .Another important ability of 3D TVS is volume calculation using the Virtual Organ Computer-aided AnaLysis (VOCAL) even in irregularly shaped structures. This method has been demonstrated to be more accurate than 2D-volume estimation .

• Hysteroscopy has the advantage of directly visualizing the uterine cavity and the endometrium, allowing biopsy to be taken immediately from the suspected abnormality.

Eligibility Criteria:
* Inclusion Criteria:
* Women Age \> 45 years
* with postmenopausal uterine bleeding

Exclusion Criteria:

* Women with bleeding disorders or coagulopathy
* women with cervical cancer or breast carcinoma .
* history of tamoxifen intake
* women with fibroid .
A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

The purpose of this protocol is to determine the single-dose pharmacokinetics and immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion through the inclusion of placebo controls at each dose level.


Eligibility Criteria:
Inclusion Criteria:

* Subjects required to have a know diagnosis of psoriasis vulgaris involving 5-49% of total body surface area (BSA) for at least six months prior to randomization.
* Subjects clinically insignificant abnormal laboratory or ECG test results who were otherwise healthy and met all remaining eligibility criteria.

Exclusion Criteria:

* Evidence of active bacterial or viral infections at the time of enrollment, including any history of or clinical evidence of infection with Human Immunodeficiency virus (HIV) Hepatitis B or Hepatitis C.
* Any underlying metabolic, hematologic, pulmonary, cardiac, renal hepatic, infectious, psychiatric or gastrointestional condition, which in the opinion of the investigator, placed the subject at unacceptable risk from participation in a study with potentially immunosuppresive therapy.
Kinesiotaping Versus Pilate Exercises

Sixty girls participated in this study and their main complaints were pain and cramping during menstruation. They were divided randomly into two equal groups.

Group (A) (30 girls) treated by kinesiotaping during menstruation for 3 successive menstruation. Group (B) (30 girls) treated by pilate exercises, 3 sessions per week for 3 months except the days of menstruation. Visual analogue scale to assess pain intensity, Quality of life enjoyment and satisfaction questionnaire, Menstrual Distress Questionnaire, WALIDD score, Spielberger questionnaire and blood sample analysis to estimate plasma prostaglandin level were applied for each girl in both groups before and after the treatment course.

Eligibility Criteria:
Inclusion Criteria:

* Their ages ranged from 14 to 20 years old
* their body mass index (BMI) would be less than 25 Kg/m2
* having primary dysmenorrhoea

Exclusion Criteria:

* skin diseases or cardiac diseases
* irregular or infrequent menstrual cycles
* previous abdominal or back operations
Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients

To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus

This study is multi-center, single arm, open-label, phase 4 study to evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus in primary living donor liver transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who had liver transplantation from living donor and had passed over 3 months since operation.
2. Over 20 years old
3. Patients who are being treated with Tacrolimus at screening visit
4. Patients who agreed to written informed consent

Exclusion Criteria:

1. Patients who had received non-liver organs before liver transplantation or had received other organs while receiving liver.
2. Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver
3. Patients who have been diagnosed with acute rejection within 6 months and have been treated
4. Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months
5. Patients who have been diagnosed with malignant tumor within 5 years(however, the following will be excepted)

   * fully recovered from skin cancer(squamous cell/basal cell carcinoma or thyroid cancer)
   * haptocellular carcinoma without main vessel invasion
6. Patients with severe systemic infection
7. Patients who are difficult to communicate due to mental disorder
8. Patients who are in treatment for hapatitis, or are over 3 times higher than upper normal limit in liver function test(T-bilirubin, AST, ALT) or over 5 times higher than normal limit of ALP
9. Patients who are(at screening visit)

   * WBC\<1,500/mm\^3
   * PLT\<30,000/mm\^3
   * over 1.0 in Protein/creatinine ratio(UA test)
   * eGFR\<30mL/min/1.73m\^2(MDRD)
   * Total Cholesterol\>350mg/dL or Triglycerides\>500mg/dL
10. Patients taking HCV(hapatitis C virus) therapeutic drug or anti-HCV positive patients who have positive result in HCV RNA test at screening visit
11. Patients who had plasmapheresis within 1 week
12. Those who are pregnant, nursing, or are not practicing contraception with appropriate method
13. Patients who had plasmapheresis within 3 months
14. if participated in other trail within 4 weeks(28 days)
15. In investigator's judgement
Microwave Imaging in NeuroTrauma

The study aims to investigate whether microwave-based technology can be used as a bedside decision-making aid to identify patients who may have a bleed in their head.

The MD100 is a microwave-based head scanner, developed for the purpose of detecting strokes. In clinical trials, it was noticed that the device performed better when the patient suffered a stroke due to a bleed. It was believed that this device had wider applications in trauma care.

The MD100 has demonstrated a very high level of accuracy in detecting bleeds in small clinical trials in the non-acute setting. The device is supported by software that determines the presence of a bleed.

This study will be set in the emergency department of major trauma centres. Patients that have sustained a head injury will be considered for enrollment into the study. Following a head CT scan, patients will be scanned by the MD100. The trial will run in two phases.

In phase one: the findings from the patient's head CT scan will be used to trial the device and teach the software what it is scanning. In phase two: The MD100 will be tested to see whether it can concur with the findings of the patient's CT scan, this will be used to determine the accuracy and reliability of the device.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and over.
* Blunt head trauma
* The patient has had a CT head scan

Exclusion Criteria:

* Patients with head injuries penetrating the skull
* Patients with radiologically confirmed cervical spine fracture
* Patients with radiologically confirmed depressed skull fracture and/or dislocation
* Patients with implanted metal in or around their skull (including titanium places and surgical staples)
* Confirmed pregnancy
* Per the investigator's judgement, any condition or symptoms preventing the patient from entering the trial.
VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)

The proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on improving health and quality of life in older women undergoing breast cancer (BCa) treatment. This study tests if delivered home-based group CBSM (R-CBSM) improves response to influenza vaccine (IV) in parallel with improved psychological adaptation, inflammation and other immune functioning indicators in older women treated for BCa.


Eligibility Criteria:
Inclusion Criteria:

1. Must meet the criterion of a score of \>14 on the Impact of Event Scale-Intrusion scale (IES-I48) for cancer-specific distress or self-report at least moderate distress (score of 4 or greater) on a screening question, "How would you rate your distress level, over the past week, on a scale of 0 to 10, with 0 meaning no distress and 10 being extreme distress"
2. No prior history of cancer (with the exception of non-melanoma skin cancer)
3. Life expectancy of \> 12 months.
4. No diagnosis of major psychiatric condition or mental disorder (i.e. schizophrenia, psychosis, and/or bipolar disorder) or active (in the past 12 months) Major Depressive Disorder (MDD), panic disorder, Post Traumatic Stress Disorder (PTSD) diagnosis or history of suicide thoughts, attempts or plans.
5. No substance dependency in the past 12 months.
6. No acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases)
7. No prior neo-adjuvant therapy
8. No current medications that act as direct immunomodulators (e.g., Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interferons)
9. No significant cognitive impairment, must score \<31 on the Telephone Interview for Cognitive Status (TICS)49.
10. At least a 6th grade reading level in English and be available for follow-up
11. Women age 50 and older diagnosed with stage 0-III breast cancer.

Exclusion Criteria:

* Does not meet all Inclusion Criteria.
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome

The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.

When required, due to an infection, patients with short bowel syndrome will be treated with an intravenous antibiotic. The pharmacokinetic profile of that intravenous antibiotic will be determined. Once the full treatment with the intravenous antibiotic is over, the patient will be orally administered the same antibiotic, with determination of the oral pharmacokinetic profile, and both profiles will be compared, assessing the bioavailability of the oral antibiotic.

Eligibility Criteria:
Inclusion Criteria:

* Short bowel syndrome
* Treated for a documented infection with antibiogram by amoxicillin (+/- clavulanic acid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim
* Hospitalized in the Nutritional Assistant Unit or the Infectiology Unit of the Regional University Hospital of Nancy
* Affiliated to a social security system
* Having received an physical examination before entering study
* Having received full information regarding the study organization and having signed the informed consent

Exclusion Criteria:

* Patient at risk of worsening their oral absorption abilities during study
* Patient requiring dialysis
* Women of childbearing age without efficient birth control
* Allergy to any of the drugs tested
* Person concerned by Articles L. 1121-5, L. 1121-7 et L1121-8 of the Code of public health
* Person deprived of liberty or person undergoing psychiatric care pursuant to articles L. 3212-1 et L. 3213-1
Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy male or female between the ages of 18 and 45 years of age
* Subject does not smoke

Exclusion Criteria:

* Subject has a history of any illness that might pose additional risk to participation or confound the results of the study
* Subject has a history of hepatitis B or C or significant drug allergies
Gene Therapy Clinical Study in Adult PKU

This is a Phase 1/2, open-label, randomized, concurrently-controlled, dose escalation study to evaluate the safety and efficacy of HMI-102 in adult PKU subjects with PAH deficiency. Participants will receive a single administration of HMI-102 and will be followed for safety and efficacy for 1 year.

Part 1 of this study will evaluate the safety and efficacy of HMI-102 gene therapy in adult subjects with PKU due to PAH deficiency. Subjects will receive a single dose of HMI-102 administered intravenously. Up to 3 dose levels of HMI-102 may be investigated in this study. At a given dose level, a minimum of 2 subjects will be enrolled and dosed. Dosing of the first two subjects will be staggered. Following evaluation of data from the first 2 subjects in a cohort, a decision can be made to either escalate to the next dose level or expand the cohort at the selected dose level. Additional doses may be added by HMI to investigate intermediate or higher doses.

In Part 2 dose expansion, evaluation of up to 2 dose levels is planned. Subjects will be randomized to receive HMI-102 or a concurrent delayed treatment control arm. Subjects in the delayed treatment control will be eligible to receive HMI-102 after 28 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Adults 18-55 years of age at the time of informed consent
* Diagnosis of phenylketonuria (PKU) due to PAH deficiency
* Two plasma Phe values with a concentration of ≥ 600 μmol/L drawn at least 72 hours apart during the screening period and at least one historical value ≥ 600 μmol/L in the preceding 24 months.
* Subject has the ability and willingness to maintain their baseline diet, whether Phe-restricted or unrestricted for the duration of the trial, unless otherwise directed

Key Exclusion Criteria:

* Subjects with PKU that is not due to PAH deficiency
* Presence of anti-AAVHSC15 neutralizing antibodies
* ALT \> ULN and AST \> ULN
* Alkaline phosphatase \> ULN.
* Total bilirubin \> ULN, direct bilirubin \> ULN
* Serum creatinine \>1.5x ULN
* International normalized ratio (INR) \> 1.2
* Hematology values outside of the normal range (hemoglobin \<11.0 g/dL for males or \<10.0 g/dL for females; white blood cells (WBC) \<3,000/μL; absolute neutrophils \<1500/μL; platelets \<100,000/μL)
* Hemoglobin A1c \>6.5% or fasting glucose \>126 mg/dL
* Any clinically significant abnormal laboratory result at screening, in the opinion of the Investigator
* Contraindication to corticosteroid use or conditions that could worsen in the presence of corticosteroids, as assessed and determined by the investigator
* Previously received gene therapy for the treatment of any condition.