cyrilzakka/clinical-trials huggingface dataset:
Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)

The objectives of this study are:

* To validate the inter-rater and intra-rater reliability of a new scale for the assessment of ataxia and neurologic dysfunction (STAND)
* To assess common constructs and correlation between STAND subscale items.

There are few validated, comprehensive rating scales for the assessment of ataxia severity. The development of a Scale To assess Ataxia and Neurologic Dysfunction (STAND) would examine and measure as many facets of ataxia as possible. Scale items to be measured include parkinsonism, timed gait analysis, dystonia, neuropathy and peripheral nerve weakness, as well as other areas of clinical manifestation for ataxia. This brief but thorough scale should yield a thorough measurement of ataxia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ataxia.
* Male or female between 18 and 80 years of age.
* Subject has voluntarily signed an IRB approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.

Exclusion Criteria:

* Any illness that in the investigator's opinion preclude participation in this study.
* Subjects with a cardiac pacemaker
* Legal incapacity or limited legal capacity.
Hyperbaric Oxygen for Post Concussive Syndrome

We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post Concussive Syndrome.

Purpose:

The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in decreasing symptoms in patients with a diagnosis of chronic post concussive syndrome (PCS).

Hypothesis:

The study hypothesis is that HBOT will decrease symptoms measured by standard measurement tools when provided to patients who have a diagnosis of PCS and are 6 months to 36 months post injury.

Study Overview:

Hyperbaric oxygen therapy (HBOT) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. HBOT produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level.

Participants will be selected from the post-concussive syndrome population based on an expectation that they would experience a clinically significant improvement. Eligible subjects will be experiencing post concussive symptoms related to an injury within the last 6 to 36 months. The study will be enrolling 150 participants and will be randomized to two different treatment arms: experimental group and a waitlist group.

Each participant will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.There will be assessments completed before treatment series begins, at the end of treatment, 8 months and 14 months after treatment begins. The primary outcome will be administered at these times as well as every two weeks once treatment begins until the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak English and give informed consent.
* A diagnosis of chronic PCS made by a referring physician
* Time of injury between 6 and 36 months previously
* Able to sit in the chamber for 120 minutes.

Exclusion Criteria:

* Untreated collapsed lung (pneumothorax)
* Have taken the chemotherapy drug Doxorubicin within 72 hours
* Have taken the chemotherapy drug Bleomycin within 4 months
* Bowel obstruction
* Heart pacemaker that has not been certified as safe for exposure to 2.0 ATA
* Pregnancy
* Severe Chronic Obstructive Pulmonary Disease (COPD)
* Participation in other PCS related studies.
* Previous recent HBOT
* Previous recent deep sea diving experience
Cream Containing Sericin and Turmeric in Psoriasis Patients

Psoriasis lesion is divided into two parts. Half of the lesion will apply cream containing sericin and turmeric and another will apply steroid cream (control). The samples will be apply two times a day for 8 weeks. Psoriasis area and severity index, physician global assessment, body surface area of lesion, dermatology life quality index, Itching score, adverse reaction are evaluated before, after using the samples for 4 and 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patients with body surface area of psoriasis lesion less than 10, have psoriasis area and severity index less than 10 , and no lesion at face, hands,feet, and genital area
* No topical application on psoriasis lesion at least 2 weeks
* Willing to attend the study

Exclusion Criteria:

* Uncontrolled diseases
* Allergic to sericin turmeric and steroid
* Other skin diseases
* Pregnancy and lactation
ClearPetra™ Vacuum-assisted Ureteral Access Sheath Vs Traditional Approach

Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm. This procedure is usually performed together with ureteral access sheaths, which helps protect the ureter mucosa and lowers intrarenal pressure.

Recently, a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration.

Because there is little information on comparing this device with traditional approach (no sheath or non-vacuum-assisted sheath) in American population, we aim to compare those devices in terms of their ability to clear the kidney from kidney stones, as well as reduce infection rates postoperatively.

Retrograde intrarenal surgery (RIRS) is now considered gold-standard for treatment of renal stones smaller than 2 cm. This procedure often employs a ureteral access sheath (UAS), as it helps to reduce intrarenal pressure and protects the ureter mucosa when basketing is required. However, the challenge imposed by residual stone fragments and sepsis remains. Additionally, natural elimination of residual stone fragments may induce renal colic, hematuria an even the potential for new stone development. Recently, a new vacuum-assisted ureteral access sheath (VA-UAS) named ClearPetra™ provides concomitant stone fragmentation and aspiration.

The new ClearPetra™ vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones. It is a disposable access sheath equipped with a continuous flow aspiration mechanism. Previous studies have demonstrated the safety and effectiveness of ClearPetra™ in RIRS Comprehensive comparative investigations between ClearPetra™ and traditional UAS in RIRS are lacking in American population. We aim to compare the outcomes of using VA-UAS (ClearPetra™) or traditional approach (no sheath or non-vacuum-assisted sheath) to treat patients with stone burden between 1.0 - 2.5 cm.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females over18 years of age
2. Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
3. Total stone burden between 1.0 to 2.5 cm

Exclusion Criteria:

1. Undergoing bilateral stone treatment during the same procedure
2. Patients with known genitourinary anatomical abnormalities
3. Uncorrected coagulopathy
4. Patients with urinary diversions
5. Chronic external urinary catheters
6. Women who are pregnant
7. Immunosuppressed patients
8. Non-elective procedures
Relationship Between Oral Health and Diabetes

The aim of this study is to assess the state of knowledge and practices in oral health of diabetic patients through the use of two questionnaires. It is also to analyse the link between the oral health status and the profile of diabetic patient, by carrying out an oral assessment for voluntary patients.


Eligibility Criteria:
Inclusion criteria:

- All diabetic patients over 18 coming to the CHU Lapeyronie

Exclusion criteria:

-Non diabetic patients, diabetic patients under 18
Japanese Study of Ipilimumab Administered in Combination With Paclitaxel/Carboplatin in Patients With Nonsmall-cell Lung Cancer

The primary purpose of this study was to establish the recommended dose of ipilimumab administered in combination with paclitaxel and carboplatin in Japanese patients with nonsmall-cell lung cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically documented nonsmall-cell lung cancer (NSCLC) presenting as stage IIIB disease without indications for definitive radiotherapy, stage IV disease, or recurrent disease following radiation therapy or surgical resection
* No prior chemotherapy, hormonal therapy, immunotherapy, or targeted-therapy-containing regimens for the treatment of NSCLC
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance score of 0-1
* Adequate bone marrow function
* Hemoglobin ≥9.0 g/dL
* Absolute neutrophil count ≥1,500/mm\^3
* Platelet count ≥100,000/mm\^3
* Adequate liver function
* Total bilirubin level ≤2.0\*the upper limit of normal (ULN)
* Asparate aminotransferase level ≤2.5\*ULN
* Alanine aminotransferase level ≤2.5\*ULN
* Adequate renal function
* Calculated creatinine clearance based on Cockcroft and Gault formula ≥50 mL/min.

Key Exclusion Criteria:

* Symptomatic central nervous system (CNS) metastasis or active CNS metastasis requiring medication
* Malignant body cavity fluid (eg, pleural effusion, cardiac effusion, ascites) that recurred despite appropriate supportive care
* Prior radiation of ≥30% of major bone-marrow containing areas (pelvis, lumbar spine)
* Documented history of severe autoimmune or immune-mediated symptomatic disease that required prolonged (longer than 2 months) systemic immunosuppressant treatment
* Documented history of motor neuropathy considered of autoimmune origin (eg, Guillain Barré syndrome)
* Any concurrent malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, carcinoma of the mucous membrane of the gastrointestinal tract, or superficial bladder cancer treated with systemic therapy
* ≥Grade 2 diarrhea
* History of or concurrent disease of gastrointestinal tract perforations
* ≥Grade 2 peripheral neuropathy (motor or sensory)
* Uncontrolled intercurrent illness including infection requiring systemic therapy, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled angina pectoris, uncontrolled peptic ulcer, and cardiac arrhythmia requiring medication
* Positive finding for human immunodeficiency virus antibody, hepatitis B surface antigen, or hepatitis C virus antibody.
SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia

The aim of the project is to experimentally compare SpO2 measured on a wrist by commercial Smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

The newest models of smartwatches measure peripheral blood oxygen saturation (SpO2) and the technology is rapidly improving. The results of individual studies on the accuracy of SpO2 measurement using smartwatches from different brands are still inconclusive. The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history

Exclusion Criteria:

* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* injury to the upper limbs or hands that could affect the peripheral perfusion
* diabetes
* hypotension or hypertension
Speech Hero Home Therapy for Aphasia

The investigators will run an at-home usability study of a newly developed speech therapy app called Speech Hero with 10 individuals with Broca's aphasia in the chronic stage of stroke. The Speech Hero app allows users to perform rhythm-based speech exercises at home. For this study participants will be instructed to use Speech Hero for at least 10 hours over a 4-week period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Broca's aphasia due to stroke,
* \>6 months post stroke
* sufficient motor function of the unaffected upper extremity to tap on a table while speaking

Exclusion Criteria:

* Incidence of other neurological diseases (though individuals with apraxia will be included)
* age \<85
A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) Genotype

To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype

This is a pharmacokinetic study designed to compare the metabolism of ARQ 197 in normal healthy volunteers who are extensive metabolizers (EM) or poor metabolizers (PM) as defined by CYP 2C19 genotype. This is an open-label, single-dose, parallel group design in which healthy volunteer subjects will receive a single dose of ARQ 197

Eligibility Criteria:
Inclusion Criteria:

* Subject must provide written informed consent prior to any study related procedures
* Subjects must be between the ages of 18 and 65 years old
* Male participants must be surgically sterilized
* Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
* Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures

Exclusion Criteria:

* Subject must provide written informed consent prior to any study related procedures
* Subjects must be between the ages of 18 and 65 years old
* Male participants must be surgically sterilized
* Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
* Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures
Oral Mucosal Absorption Study of Bicalutamide New Formulation

The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects

Oral mucosal absorption study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Japanese healthy male subjects aged 20 to 45 years
* Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
* Have a body mass index (BMI) between 17 and 27 kg/m2
* Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)

Exclusion Criteria:

* Presence of any disease under medical treatment
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
* Presence of any infectious disease, such as bacteria, virus and fungus Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
* Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation
Open-Label Trial of the Use of Minocycline in the Treatment of Asthma

The tetracycline minocycline has, in addition to its anti-infective properties, anti-inflammatory properties which may be of use in the treatment of asthma. This study evaluates the benefit of minocycline as add-on therapy for adults with asthma.

Adult asthmatic (ages 18 to 75 years) with a history of moderate to severe persistent asthma are given minocycline capsules as add-on therapy for treatment of asthma. Treatment is for one year. Dosing begins at 150 mg twice daily and can increase every eight weeks by 50mg BID to a maximum of 250 mg twice daily. This is as per patient tolerance as minocycline can cause dizziness and stomach upset, as well as effects of liver enzymes.Patients undergo routine blood toxicity screens every two months, at which time spirometry is performed Exclusion criteria: pregnant women (adequate contraception in mandated) previous history of hypersensitivity to tetracyclines, chronic liver disease Outcome measures: improvement in FEV1 and other spirometric parameters, decrease in oral steroid requirements, change in total serum IgE, improvement in quality of life

Eligibility Criteria:
Inclusion Criteria:

* Adults (ages 18 to 75 yrs)
* Mild to severe asthma
* History of or current oral steroid use to control asthma atopy

Exclusion Criteria:

* Pregnant women
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer

Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis with indication of total mastectomy and breast reconstruction
* Indication of post-mastectomy radiation therapy
* Availability to be followed up for 24 months
* Signature of informed consent

Exclusion Criteria:

* Patients candidated to breast-conserving surgery
* Contraindicated breast reconstruction (severe comorbidities, unfavourable survival outcome expected, distant metastases)
* Patients affected by other solid malignancies
* Pregnancy
* Participation to other clinical studies in the last three months
Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.

This study is a prospective, multi center randomized double blind, two arm study.

90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is 18 to 70 years of age.
2. The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
3. The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening.
4. The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities

Exclusion Criteria:

1. Grade I and IV on the knee Kellgren-Lawrence grading scale
2. Subject has clinically 3+ effusion of the target knee (stroke test grading system).
3. Subject has significant (\> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
4. Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
5. Viscosupplementation in any joint in the past six months.
6. Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin).
7. Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months
8. Subject has inflammatory disease of either knee other than OA.
9. Subject with underlying medical conditions that could interfere with the evaluation of the outcome.
10. Subject with positive pregnancy test, or breast feeding.
11. Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months.
12. Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13. Subject has rheumatoid arthritis or gout
14. Subject has a history of or a current infection at the affected joint.
15. Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
16. Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.