cyrilzakka/clinical-trials huggingface dataset:
Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects.

Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.

Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.

In part I, four patients who are now receiving AZT at the usual dose take part in pharmacokinetic studies (how much of the drug enters the blood stream, what happens to the drug in the body, and how it leaves the body) of AZT defined after a dose while at steady state and then again after a new steady state has been reached following the addition of quinine sulfate. Part II studies the pharmacokinetics of AZT in eight patients receiving AZT at 1 of 2 doses and then at the lower dose of AZT plus probenecid with or without quinine.

Eligibility Criteria:
Inclusion Criteria

Patients must:

* Have symptomatic HIV infection.
* Be taking zidovudine (AZT), 100 or 200 mg, 5 or 6 x/day.

Allowed:

* History of Pneumocystis carinii pneumonia (PCP).
* Advanced AIDS related complex (ARC).
* HIV antibody positive with an absolute CD4 lymphocyte count of \< 200 cells/mm3 before study entry.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions are excluded:

* Glucose-6-phosphate dehydrogenase deficiency.
* Allergy to sulfa drugs, probenecid, or quinine.

Concurrent Medication:

Excluded:

- Other drugs that might influence the metabolism or renal excretion of zidovudine (AZT).
Study of Talabostat and Cisplatin in Advanced Melanoma

The purpose of this study is to assess the antitumor activity and safety of the combination of talabostat and cisplatin in patients with metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed melanoma that is metastatic (unresectable Stage IV per AJCC 2002)
* Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins
* ECOG Performance Status of 0, 1, or 2
* Expected survival ≥12 weeks
* Written informed consent

Exclusion Criteria:

* More than 1 prior chemotherapy or biotherapy regimen for metastatic melanoma
* Radiation therapy to \>50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
* Clinically significant laboratory abnormalities
* Symptomatic CNS metastases
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* The need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
* Pregnant or lactating women.
Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

To obtain a better understanding on the comparative effectiveness of rivaroxaban versus VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial fibrillation) in a real-life setting


Eligibility Criteria:
Inclusion Criteria:

* NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD(International Classification of Disease)-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
* Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
* CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category)

Exclusion Criteria:

* Patients \<18 years of age
* Patients with valvular AF (Atrial fibrillation)
* Pregnancy
* Malignant cancers
* Transient cause of AF
* Patients with venous thromboembolism (pulmonary embolism or deep vein thrombosis)
* Patients with major surgery defined as hip or knee replacement
* Prescriptions of oral anticoagulants (OACs) (apixaban, warfarin, dabigatran, rivaroxaban) before index date
* Prescription of more than one OAC on the index date
* Patient with any of the events defined in the composite endpoint

  * Fatal bleeding
  * Fatal Stroke/Myocardial infarction
  * Intracranial hemorrhage
  * Ischemic stroke
  * Myocardial infarction
CREM - Clinical and Functional Outcomes in a Controlled Clinical Trial with Older Adults

To evaluate and compare the effects of different types of physical exercise on clinical and functional outcomes in the elderly. 240 community-dwelling elderly individuals of both sexes, sedentary, will be recruited for twelve groups of elderly individuals who will receive intervention for 32 weeks of different types of physical exercise (free walking, Nordic walking, dancing, physical exercise for cognition, balance, aquatic physiotherapy, multicomponent gymnastics, water aerobics, hydro-postural exercises, aquatic jogging, weight training, and Pilates mat). The training programs will have a frequency of two sessions per week and will last 50 minutes and will be periodized so that the duration of the sessions is equal among them. In order to evaluate the effects of the training, evaluations will be carried out before, during and after the training period of functional fitness, clinical-functional and biomechanical parameters. It is expected that the intervention groups will present results according to the nature of the modality and that they will be more effective when compared to the control group. As well as improvements in the variables of gait speed, muscle strength, balance and cognition.


Eligibility Criteria:
Inclusion Criteria:

* elderly people over 60 years old,
* sex female our male,
* presenting medical authorization to practice exercises,
* being able to understand verbal instructions for carrying out the tests,
* having accessibility to carry out the training,
* coming from local Health Units and the community,
* presenting independent walking and not having participated in any physical activity for at least three months before starting the research.

Exclusion Criteria:

* not having a medical certificate indicating that they are fit to perform physical activity,
* presenting medical comorbidities and/or a medical condition that contraindicates participation in the study, severe heart disease, uncontrolled arterial hypertension, myocardial infarction within a period of less than one year or history of physical-cognitive impairment, sequelae of a stroke,
* having a pacemaker,
* having undergone recent surgery,
* prosthetics in the lower limbs or neuropathic pain in the lower limbs.
Report of a New Method Used to Identify the Bacteria Present in a Human Colon Biopsy Sample

The method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. Therefore, this methodology may prove useful to other researchers or physicians.

The method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. The molecular method worked well, so it is appropriate to share the method with the medical and scientific communities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ulcerative colitis
* Age \>= 18 years old
* Female

Exclusion Criteria:

Anyone not meeting inclusion criteria.
The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship

Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 80 years old;
2. First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae (mRS = 0-2);
3. Acute anterior circulation cerebral infarction with large artery atherosclerotic etiology;
4. Ability to randomize within 48 h of time last known free of new ischemic symptoms.
5. National Institute of Health stroke scale(NIHSS) ranges from 7 to 22;
6. signed written informed consent.

Exclusion Criteria:

1. Cerebral CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
2. Transient ischemic attack;
3. Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;
4. Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time (according to its instruction), or need to be treated with ACEI;
5. Past or present suffering from hemorrhagic tendency of the disease;
6. The investigator in consideration of the other condition that the patients doesn't fit to participate in this clinical study.
HEart Surgery In Atrial Fibrillation and Supraventicular Tachycardia

Atrial fibrillation is the most common cardiac arrhythmia, the incidence of which increases drastically with age. As more and more elderly patients undergo heart surgery, the proportion of patients in this population will increase. Atrial fibrillation has been shown to be a poor prognostic factor in several surgical situations. The aim of our study was to assess long-term mortality among patients with preoperative AF under various cardiac surgery settings, with a particular emphasis on the strategy of coronary revascularization.


Eligibility Criteria:
Inclusion Criteria:

* Referred for heart surgery,
* preoperative atrial fibrillation

Exclusion Criteria:

* age\<18 years old
Psychological Impact of Quarantine in Chronic Pain Patient During COVID-19 Outbreak

In the context of quarantine with COVID-19, we will study the experience and psychological impact of pain in adult patients living with chronic pain. We will evaluate the link between the question of physical and psychological confinement in the experience of pain in this particular situation


Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic pain
* Patient in confinement
* Patient with sufficient understanding of the French language

Exclusion Criteria:

* Non adult patient
* patient without quarantine
Cell Therapy in Limb Girdle Muscular Dystrophy

The purpose of this study was to study the effect of stem cell therapy on Limb Girdle Muscular Dystrophy patients.


Eligibility Criteria:
Inclusion Criteria:

* age group of 15 years-60 years
* limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
* Electromyographic and Nerve Conduction velocity findings

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding
A Study for Observing Severe Asthma in Patients Treated With Tezepelumab

A study involving primary data collection within real-world settings of participants who initiate treatment with tezepelumab for severe uncontrolled asthma. This study will complement evidence obtained from randomized controlled trials and provide new data focusing on the holistic and patient reported outcome (PRO).

This is a 12-month, multi-country, multi-center, prospective, non-comparative and non-interventional (observational), post-reimbursement real-world evidence study that will assess asthma symptom control, lung function, and patient-reported outcomes including health-related quality of life after tezepelumab treatment initiation in participants with severe asthma in Europe and Canada. This study is planned to be conducted in several countries including but not limited to Canada, Germany, Denmark, Switzerland, and Sweden.

Participants will be followed for a maximum period of 52 weeks after tezepelumab treatment initiation, irrespective of treatment discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 12 years or older
* Provision of signed and dated written informed consent, including assent for minors
* Prescribed treatment with Tezepelumab
* Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses
* Received at least one prescription of medium-dose to high-dose inhaled corticosteroids (ICS) during the 52 weeks prior to enrolment date
* Use of additional asthma maintenance controller medication(s) for at least 52 weeks prior to enrolment date
* Documented history of at least 1 asthma exacerbations during the 52 weeks prior to enrolment date
* Individuals with ACQ-6 score ≥ 1.5 (indicating inadequate asthma symptom control) at enrolment or up to 12 weeks before enrolment
* Participants currently receiving care from pulmonologists and/or allergists
* Participants who are able to understand and complete the ePROs
* Availability of participants medical records for asthma exacerbation and Healthcare Resource Utilization (HCRU) for the 52 weeks prior to Tezepelumab initiation

Exclusion Criteria:

* Any contraindication to Tezepelumab
* Participants on concurrent biologics for asthma at the time of receiving the first dose of Tezepelumab will be excluded except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment)
* Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months
* Pregnancy or lactation period.
COPD in Obese Patients

The study included 176 patients with COPD. The first group included 88 normal weight patients with COPD: 71 men and 17 women, mean age 62.40 ± 8.83 years. The second group included 88 patients with COPD and obesity: 64 men and 24 women, mean age 62.94 ± 5.96 years. We assessed the frequency of COPD exacerbations in last 12 months, the severity of symptoms such as dyspnea, sputum production, fatigue. Spirometry, six-minute walk test and analysis of body tissue type composition were performed. BODE index was calculated. Levels of leptin, adiponectin, interleukins-4,6,8,10, interferon-γ, c-reactive protein (CRP), tumor necrosis factor receptor 1 (TNF-R1), tumor necrosis factor receptor 2 (TNF-R2), tumor necrosis factor alpha (TNF-α) were measured in blood serum.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis, informed consent for voluntary participation in the study

Exclusion Criteria:

* patient participation in any interventional study,
* COPD exacerbation,
* concomitant lung diseases, such as confirmed or suspected malignant lung disease or other respiratory disease, such as interstitial pulmonary fibrosis, tuberculosis, sarcoidosis, bronchial asthma, bronchiectasis,
* concomitant diseases of other organs and systems, such as acute cardiovascular diseases, chronic kidney diseases and liver failure.
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat

RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to detect the spread of mouth and throat cancer to lymph nodes in the neck.

PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have mouth or throat cancer.

OBJECTIVES:

* Evaluate the sensitivity of lymphoscintigraphy and isosulfan blue in localization of sentinel lymph nodes in patients with previously untreated squamous cell carcinoma of the oral cavity or oropharynx.
* Determine evidence of micrometastases in histologically normal sentinel lymph nodes resected from these patients.
* Assess the clinical significance of micrometastases in lymph nodes resected from these patients.

OUTLINE: Patients undergo preoperative lymphoscintigraphy utilizing technetium Tc 99m sulfur colloid followed by intraoperative injections of isosulfan blue at 3-4 locations into the primary tumor periphery. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo cervical lymphadenectomy followed by resection of the primary tumor.

Resected primary tumor, radioactive lymph nodes, and blue-stained sentinel nodes are then subjected to molecular (polymerase chain reaction) and histocytochemical (immunohistochemistry for cytokeratin and micrometastases, light microscopy) analyses.

Patients are followed at 1, 3, 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary squamous cell carcinoma of the oral cavity or oropharynx

  * Stage 0-IVA (Any T, N0)
* No low-risk tumors
* Must require elective staging neck dissection and resection of primary tumor

PATIENT CHARACTERISTICS:

Age:

* 18 to 70

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing
* No concurrent impaired mental status

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* See Disease Characteristics
* No prior surgery
The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters

tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.Several studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients. The aim of this study was to test whether daily sessions of anodal tDCS repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients. The cathode is usually applied over the right forhead above the eye. The aim of the study is to test whether daily sessions of tDCS repeated for 5 consecutive days will influence on ophthalmologic parametrs.

tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.Several studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients. The aim of this study was to test whether daily sessions of anodal tDCS repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients. The cathode is usually applied over the right forhead above the eye. The aim of the study is to test whether daily sessions of tDCS repeated for 5 consecutive days will influence on ophthalmologic parametrs.

Patients will recieve tDCS in a 5-day period of treatment. The participants will go through full ophtalmologic examination before and after the treatmnet In addition to the ophtalmologic examination Pain will be measured using visual analog scale (VAS) for pain and the short form McGill questionnaire (SF-MPQ). Disability will be measured using the ( Pain Disability Index (PDI) of Life-54 scale (MSQoL-54). Depressive symptoms and anxiety will also be evaluated using the Center for Epidemiological Studies-Depression Scale and the State-trait Anxiety Inventory (STAI). Cognitive function will be mesured using minimental test.

Eligibility Criteria:
Inclusion Criteria:

* patients who suffer from chronic pain VAS\>4

Exclusion Criteria:

* pregnancy
* scalp lacerations
* history of seizures
* metal implants in the head
* heart pace maker
* ophthalmologic disease.
* The presence of deep brain stimulation system
23andMe IPF Research Study

The long term goal of this study is to increase genetic understanding of IPF to enable the development of an effective drug for IPF that can improve the lives of those living with the condition.

This study will recruit 1,000 people who have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS). Eligible participants who consent to participate in 23andMe Research and the IPF Research Study will receive a 23andMe Health + Ancestry kit at no cost. Participants will provide a saliva sample and take a baseline survey online answering questions about their disease diagnosis, testing, treatment, and symptoms. Participants will also be asked to take the same survey 3, 6, and 9 months after completing the baseline survey. The data collected from this study will be incorporated into the 23andMe Database and used to better understand the underlying genetic and environmental factors that contribute to IPF.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS)
* Are 18+ years old
* Live in the US

Exclusion Criteria:

- Have been diagnosed with sarcoidosis or hypersensitivity pneumonitis
Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children


Eligibility Criteria:
Inclusion Criteria:

* Glucocorticosteroid treatment for 12 months at least
* Bone age \< 15 years for a boy and \< 13 years for a girl
* Child measured height \< - 2 SD, Child currently treated by GH

Exclusion Criteria:

* Known diabetes (type 1 or type 2)
* A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures