cyrilzakka/clinical-trials huggingface dataset:
Characterization of the Profile of Dysarthria in Huntington's Disease, Using the Clinical Evaluation Battery of Dysarthria

Huntington's disease is a hereditary disease of rare autosomal dominant transmission, both neurodegenerative and neuro-psychiatric. Clinically, there are motor symptoms (chorea), cognitive disorders (dementia) and psychiatric disorders.

Among motor disorders, dysarthria is a commonly found symptom. This is classically referred to as hyperkinetic dysarthria according to the criteria of Darley's classification. However, this old classification (1969) is only based on perceptual analysis and lack of specificity.

Moreover, in the course of the disease, chorea (control of the striatal attack D2) decreases to give place to a parkinsonian syndrome (control of the striatal attack D1) and the dysarthria also evolves towards a hypokinetic form . It also seems likely that cerebellar involvement (responsible for ataxia) contributes to dysarthria.

No studies have been published to date to characterize dysarthria in Huntington's disease in a quantified, objective and specific manner. However, Canan Ozsancak describes choreic dysarthria as heterogeneous according to the patients and variable according to the productions. A perceptual study reports an imprecision of the consonants, a lengthening of the pauses, a variable flow, an absence of modulation of the pitch and a hoarse voice.

Finally, few patients are cared for in speech therapy and there is no specific rehabilitation strategy: this would require - and justify a more precise study of the dysarthria of these patients.

The Clinical Evaluation of Dysarthria developed by Pascal Auzou and Véronique Rolland-Monnoury is a recent and partially standardized tool, combining qualitative and quantitative evaluation, which seems adapted to try to better characterize the dysarthria in Huntington's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Patients HD
* Major Patients
* French-speaking patients
* MMS score greater than 20
* Patients with informed consent signed
* Patients covered by a social insurance system

Exclusion Criteria:

* Patients with intercurrent pathologies or other psychiatric disorders that may interfere with battery replacement (at the discretion of the investigator)
* Illiteracy
* Persons placed under safeguard of justice (adults under guardianship or guardianship) or deprived of their liberty
Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed cervical cancer
* radical hysterectomy and pelvic lymph node dissection was done
* histologically indicated adjuvant radiotherapy ( more than one as below)

  1. tumor size ≥4 cm
  2. positive lymphovascular invasion
  3. more than half stromal invasion depth
* ECOG performance status 0 or 1
* Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl

Exclusion Criteria:

* positive pelvic lymph node metastasis
* positive distant metastasis (including retroperitoneal lymph node metastasis)
* positive tumor involvement on resection margin
* positive parametrial invasion
* previous history of pelvic radiotherapy
* more than 3 months after radical surgery for cervical cancer
* neoadjuvant chemotherapy was done
* previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
A Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both paliperidone and risperidone are second generation antipsychotics，but have same pharmacological effects of antipsychotic treatment and paliperidone may have more efficacy and safty.This study was designed to examine the acute efficacy, safety, and tolerability of paliperidone and risperidone for patients with MAP.

Methods:A Multiple-Center, Randomized, Double-Blind.

Eligibility Criteria:
Inclusion Criteria:

1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
2. Must sign a Information consent form.
3. Required to provide detailed address and phone number

Exclusion Criteria:

1. Serious organic disease.
2. Suicide ideation or hurt others.
3. Taking antipsychotic within two weeks before.
4. drug allergy to Risperidone or paliperidone.
5. pregnancy and breastfeeding women.
Tigecycline In-Vitro Surveillance Study In Taiwan

In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Clinically relevant causative isolate (no duplicates) - The isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection.
* Sources - All body sites are acceptable clinical sources for isolates to be included in this study (Intra-abdominal infection, tracheal secretion/bronchoalveolar lavage, blood culture, wound smear). However, no more than 10 % of all isolates can come from urine cultures.
* Within study group - Only isolates defined by the protocol are to be included.

Exclusion Criteria:

* Limited isolates from sources - No more than 10 % of all isolates from this study will be derived from urine cultures.
* No banked or stored isolates.
* No duplicate isolates - Only one isolate per patient is permitted.
* Outside study group - Any isolate other than those defined by protocol.
Oncotype DX in BRCA-mutated Breast Cancer Patients: Our Experience. A Retrospective Observational Monocentric Study

The study aims to evaluate the distribution of the Oncotype DX RS® genomic test in patients with ER-positive and HER2-negative breast cancer treated from January 2012 to December 2021, focusing on patients presenting germline mutations.

In the past decades, genetic testing for cancer susceptibility has become essential in breast cancer (BC) management. Up to 10% of BC cases are associated with an inherited mutation in various genes, especially BRCA 1 and BRCA 2. Estrogen receptor (ER) positivity is observed in 22% on BRCA 1 and 77% of BRCA 2 mutation carrier; moreover, other genes are strongly related to ER-positive cancer.

Oncotype DX assay (Genomic Health, Inc, Redwood City, Calif) is a 21 gene panel developed to predict the risk of tumor recurrence in patients with ER-positive and human epidermal growth factor 2 (HER2)- negative BC; nowadays, this test represents a standard of care to guide adjuvant chemotherapy decision recommended in several guidelines. According to Oncotype DX Recurrent Score (RS)® a high RS shows a worse prognosis and predicts chemotherapy benefit in patients with ER-positive HER2-negative BC.

Combining Oncotype DX RS® with other risk factor elements, in particular germline mutations, could help to select patients who would benefit from an appropriate adjuvant therapy.

This retrospective observational study aims to evaluate Oncotype DX RS® distribution in ER-positive HER2-negative BC patients treated from January 2012 to December 2021, focusing on patients harboring mutation in BC-associated genes compared to the general population.

Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis at least 18 years
* Women who underwent breast surgery in OSR
* Patients with ER-positive, HER2-unamplified early-stage BC who underwent the Oncotype DX assay, according to the standard of care.

Exclusion Criteria:

* Male
* ER negative or HER2 amplified disease
* Patient s who did not undergo breast surgery in OSR
* Patient s who did not undergo the Oncotype Dx assay
High Dose Vitamin B1 to Reduce Abusive Alcohol Use

B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain systems damaged by alcohol and help people with alcohol problems control their alcohol use. A strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much higher levels than can be achieved using normal vitamin supplements. Drinking patterns are examined over 6 months of continued supplement use. Men and women with a recent history of alcohol problems are eligible to participate.

B1AS is a randomized, double-blind placebo-controlled clinical trial of the effectiveness of Benfotiamine at reducing abusive drinking patterns in individuals with recent alcohol problems. Subjects consume 4 tablets of Benfotiamine (600 mg) or placebo daily for 6 months. Monthly follow-ups track alcohol use and alcohol-related problems over the 6 months. Blood tests are also conducted to determine the frequency of an inherited abnormality in thiamine processing that may be related to the risk of developing alcoholism.

Eligibility Criteria:
Inclusion Criteria:

* Problem drinking in the last 30 days

Exclusion Criteria:

* Prolonged abstinence
* Serious medical problems
Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial

The purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction.
2. Age 18 years or older.

Exclusion Criteria:

1. Inability to obtain consent
2. Emergency cardiac catheterization for ST-segment elevation myocardial infarction.
Evaluating Bactisure Wound Lavage in Orthopedic Wounds

To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.

This study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. WBC cell counts will be compared before and after articular irrigation with Bactisure Wound Lavage.

This study is a prospective, multi-center, single arm study involving orthopedic surgeons skilled and experienced in deep surgical debridement and in I \& D or reoperation (revision) total knee arthroplasty procedures. A maximum of seven study centers will enroll a maximum of 40 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing I \& D or reoperation (revision) surgery for an infected primary TKA.
* Patient is 18 years of age or greater.
* Patient is skeletally mature.
* Occurs within 30 days of the operation or within 1 year or more if an implant is present
* Involves deep soft tissues (e.g., fascia and/or muscle) of the incision
* Patient is willing and able to provide written informed consent.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol

Exclusion Criteria:

Patients will be excluded from this study if:

* Patient is unwilling or unable to give consent or to comply with the follow-up program.
* Known sensitivity or allergic reaction to benzalkonium chloride one or more of the solvent, chelating agent, or buffer in the solution
* Multiple (\>1) infected implants
* Medically unfit for irrigation \& debridement procedure
* Pregnancy
* The patient is:
* prisoner
* mentally incompetent or unable to understand what participation in the study entails
* anticipated to be non-compliant.
Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus

Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.

Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months.

Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (\> 12 months) of dual antiplatelet therapy

Prospective, randomized, triple arm study. The study population will include all consecutive diabetic patients within 24 months undergoing elective second generation DES implantation for de novo coronary artery disease. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 18 years old
2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent
3. Subject and the treating physician agree that the subject will comply with all follow-up evaluations
4. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria:

1. Subject's age is \< 18 years and with acute myocardial infarction in the 48 prior to the procedure
2. The patient is pregnant or breastfeeding
3. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (tiklid), heparin, Paclitaxel, Everolimus, ABT 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated)
4. A platelet count \< 75,000 cells/mm3 or \> 700,000 cells/mm3 or a WBC \< 3,000 cells/mm3
5. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
6. Prior participation in this study
7. Active peptic ulcer or upper GI bleeding within the prior 3 months
8. Subject has active sepsis
9. Any lesion that is located in a saphenous vein graft
10. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study
Landiolol in Postoperative Atrial Fibrillation

Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patient underwent conventional cardiac surgery
* Age \> 18 years
* Writing contentment

Exclusion Criteria:

* Pre-existing chronic atrial fibrillation
* Contraindication to beta-blockers
* Circulatory shock (cardiac index\<2.2 L/min and lactate\>4mmol/L)
* Distributive shock (cardiac index\>2.2 L/min with norepinephrine dose \> 0.3 µg/kg/min to reach mean arterial pressure \> 65mmHg).
* Acute respiratory distress
* Major bleeding (\>200mL/h)
* Patient already included into an interventional clinical study
* Pregnancy
* No social security insurance
* Patient not able to give consent (curators, patients deprived of public rights)
Self-Managing HIV and Chronic Disease

The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with HIV/AIDS and other chronic conditions.

450 adult HIV+ patients aged 50 or older will be randomized to one of three arms. 150 will be assigned to receive a series of ten 30-minute phone calls every two weeks from a counselor. 150 will be assigned to an attention-matched comparison arm, and will receive 10 sessions in a didactic telephone group. 150 will be assigned to a information-matched control arm and will receive the book Living Well with HIV \& AIDS. Letters will be sent by AIDS Service Organizations inviting interested clients to call the study's 800 number to learn more about the study and to be screened for enrollment. Posters and brochures will also be posted in public areas of the ASOs. The individualized intervention combines problem-solving, with motivation and self-management. This trial will allow us to evaluate the effectiveness of a multi-component intervention on both specific HIV behavioral outcomes and non-disease-specific outcomes.

Eligibility Criteria:
Inclusion Criteria:

* age 50 years or older
* HIV-positive serostatus
* currently prescribed antiretroviral medication
* antiretroviral nonadherence reported in past 30 days
* provision of oral informed consent

Exclusion Criteria:

* hearing problems that preclude participation in a telephone study
* presence of probable dementia or acute psychosis detectable by screening interview
A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.


Eligibility Criteria:
Inclusion Criteria:

Eligible subjects were:

* male or female
* at least 30 years of age
* had completed participation in a prior double-blind istradefylline trial
* met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state
* had been treated with levodopa for at least 1 year
* had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline
* were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)
* had predictable end-of-dose wearing-off

Exclusion Criteria:

* none
Real World Evidence Clinical Utility Study of KidneyIntelX

The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.

Exclusion Criteria:

* Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
* Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria.
* Patients with ESRD or on renal recovery treatments at time of enrollment.
* Patients who are pregnant at the time of enrollment.
* Patients who are currently hospitalized.
* Patients without minimum 6 month pre-baseline KidneyIntelX medical history.
* Patients who are currently on Enbrel.
Feasibility of Insomnia Tracking and Treatment in IBD

This study is a longitudinal clinical trial designed to characterize sleep patterns in individuals with Inflammatory Bowel Disease (IBD) as well as to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with both insomnia and Inflammatory Bowel Disease (IBD).


Eligibility Criteria:
Inclusion Criteria (IBD Participants):

* Documented IBD
* Mild to moderate Crohn's Disease or Ulcerative Colitis as measured by the Physicians Global Assessment

Inclusion Criteria (Healthy Participants)

* No personal history of IBD
* No personal history of Irritable Bowel Syndrome (IBS) or Celiac Disease
* No current gastrointestinal symptoms or concerns
* No family history of IBD or Celiac Disease

Exclusion Criteria (both IBD participants and healthy participants)

* PHQ-9 depression score \> 15
* GAD-7 anxiety score \> 15
* Current alcohol or substance abuse
* Current narcotic use
* Unstable major psychiatric condition
* Current sleep apnea or restless leg syndrome
* Other problems that would interfere with study participation at investigator discretion
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic peripheral arterial disease in superficial femoral artery lesions
Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.

Cervical cancer is a public health problem. In term of frequency and mortality, it represents in Martinique the third localization the most frequently diagnosed and the fifth cause of death by cancer. Cervical cancer is recognized as viro-inducted. Human papillomavirus (HPV) is the etiologic agent, as a necessary but not sufficient cause, in the cancer genesis. It is estimated than about 70 to 80% of women have been or will be infected with an HPV in their genital life, the risks factors being those of the others sexually transmitted diseases (STD). Most of HPV infection are transient, by spontaneous clearance in a few months of the virus under episomal form.

Carcinogen risk is related to viral persistency which inducts the condition of cellular transformation.

Infection persistency and subsequent carcinogen risk depend of the genotype concerned and of the host immunitary response.

HIV infection is known to be associated with an higher prevalency of one or several infection with HPV-HR.

However, no data about HIV/HPV coinfection prevalency are available nowadays in French overseas department of South America whereas they are the most affected by HIV.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years old or beyond
* Infected with HIV1 or HIV2
* Follow up for HIV infection in one of the center participating in the study and acceptance of the use of Nadis® medical files
* in one of the center participating in the study and acceptance of the use of Nadis® medical files within the context of follow up that should be realized according to the recommandation of undertaking: systematic Pap smear for asymptomatic patient s (expert's report, Pr.P.Yéni) or Pap smear for classical searching of any pathology of the uterine-cervix.
* Acceptance of involvement into the study and collection of non opposition to the realization of HPV search from the sample realized for the Pap smear.

Exclusion Criteria:

* Women under age
* History of total hysterectomy
* Patient not followed for HIV infection in one of the center involved in the study
* Patient that did not accept the use of Nadis® medical files
* Impossibility to realize a Pap smear
* Refusal of study's participation