cyrilzakka/clinical-trials huggingface dataset:
Patient Experiences With Threshold Electrical Stimulation İn Stroke: A Qualitative Study

The aim of this study is to determine patient opinions and experiences about threshold electrical stimulation treatment applied to stroke patients.

An exploratory-descriptive qualitative study will be conducted . This study will be conducted with 10 stroke patients receiving threshold electrical stimulation therapy. Threshold electrical stimulation will be applied for 4 weeks, 3 days a week, for one hour. At the end of the 4th week, semi-structured focus group interviews will be held with the patients. . In the semi-structured focus group interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Compared to taking notes by hand; It will be preferable to record the conversation with a voice recorder because it has advantages such as recording all the interviews and allowing the interviewer to focus on the interview. Thematic analysis method will be used in the evaluation of the data.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 80 years,
* Individuals without communication problems,
* Individuals who have been diagnosed with stroke

Exclusion Criteria:

* Uncontrollable arrhythmia and/or hypertension
* Presence of advanced sensory deficit
* Visual and hearing problems
* Not having sufficient communication skills (Mini Mental Test score below 24 points)
Consequences of DNA Repair and Telomere Defects on the Function of the Immune System: Application to CVID and Immune Deficiencies With Dysmorphic Syndromes

The molecular mechanisms participating in the various aspects of the DNA Damage Response (DDR) are absolutely essential to maintain the genome dynamics essential to all living organisms. The most commonly studied consequence of faulty DDR is genome instability participating in cancer onset. In the present proposal, we wish to explore another aspect of DDR, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system.

The most "spectacular" consequences of faulty DNA repair processes with respect to the immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to defective DNA joining phase during V(D)J recombination resulting in patients with Severe Combined Immune Deficiency (SCID).

The objectives of this study are to increase our knowledge on the role of the various DNA repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these DNA repair processes result in human severe conditions such as CVID, LOCID or other manifestations of immune disorders such as autoimmunity.

The explorations of DNA repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.


Eligibility Criteria:
Inclusion Criteria:

* Immune Deficiency and early BMF in childhood
* Common Variable Immunodeficiency (CVID)
* Genetic patients

Exclusion Criteria:

* Refusal to consent.
Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCT

Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy and autologous stem cell transplantation by the transplant team at WCI will be enrolled in the study.

Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy and autologous stem cell transplantation by the transplant team at WCI will be enrolled in the study. Subjects will receive HBO therapy on Days 0, +1 and +2 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes for a total of 90 minutes after compression to 2.5 atmosphere absolutes in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. Subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes will be spent during the compression and decompression phases and subjects will have 5-10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment. Subjects will be seen daily until neutrophil recovery is documented . After neutrophil recovery is documented, the subjects will be seen in clinic at least weekly through day +100. A final visit will be scheduled day +100. As part of routine care, subjects will be followed daily or as directed by the treating physician until neutrophil recovery, defined as three consecutive days of achieving a neutrophil count of \>500/mm3. Laboratory testing will occur per institutional guidelines. Follow-up will continue until Day +100. Donor chimerism and disease status will be determined by bone marrow biopsy on Day +30 and day +100 post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Multiple myeloma
* Subjects must be 18 years old
* Karnosfsky Performance of greater than 70 percent
* Adequate hepatic, cardiac and pulmonary function
* Subjects should have New York Heart Association Functional Classification of: Class 1 or Class II.

Exclusion Criteria:

* Pregnant or breastfeeding
* Severe chronic obstructive pulmonary disease requiring oxygen supplementation
* History of spontaneous pneumothorax
* Active ear/sinus infection
* Sinus surgery within the last 5 years
* Claustrophobia
* History of recurrent seizures within 5 years of study enrollment
* Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant
* Prior chest surgery involving thoracotomy or prior direct irradiation to the lungs
* Subjects who have had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen
* Active and uncontrolled viral, fungal or bacterial infection
* Use of tobacco 72 hours prior to transplant
Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety of TAS-119 and determine the most appropriate dose in combination with Paclitaxel for subsequent studies in patients with advanced solid tumors.

TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been demonstrated to enhance the activity of paclitaxel in preclinical studies

Background and rationale for study:

In nonclinical pharmacology studies TAS-119 significantly enhanced the antitumor activity of the microtubule stabilizer paclitaxel and TAS-119 is being developed for use in combination with paclitaxel.

TAS-119 selectively inhibits the kinase inhibitor Aurora A. AurA regulates cell division by controlling the transition from G2 to M phase. Overexpression of AurA is associated with resistance to taxanes.

The study will be conducted in two sequential phases:

Dose Escalation Phase with the purpose to determine the maximum tolerated dose and the recommended Phase 2 dose of TAS-119 given in combination with paclitaxel

An Expansion Phase in which additional patients will be enrolled to further evaluate the safety and preliminary efficacy of the recommended Phase 2 dose of TAS-119 in combination with paclitaxel, during which a subgroup of patients will be evaluated for DDI between paclitaxel and TAS-119 via PK assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Is a male or female ≥ 18 years of age, that has provided written informed consent.
2. Has histologically or cytologically confirmed advanced, unresectable metastatic solid tumor(s) for which the patients have no available therapy likely to provide clinical benefit, or for which paclitaxel is considered a standard of care.
3. Has adequate organ function as defined by the following criteria:

   * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤ 5 × ULN.
   * Total serum bilirubin ≤ 1.5 × ULN.
   * Absolute neutrophil count ≥ 1,500/mm3 (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \[G-CSF\]).
   * Platelet count ≥ 100,000/mm3 (IU: ≥ 100 × 109/L) (excluding measurements obtained within 7 days after a transfusion of platelets).
   * Hemoglobin ≥ 9.0 g/dL
   * Total serum creatinine ≤ 1.5 × ULN
   * Serum albumin ≥ 3.0 mg/dL.

Exclusion Criteria:

1. Previous inability to tolerate any dose of paclitaxel (i.e., the subject required a paclitaxel dose reduction or discontinuation).
2. Has received any treatments prohibited in this trial within specified time frames
3. Has a serious illness or medical condition(s) that would affect safety or tolerability of the study treatments
4. Has history of Grade 2 or greater peripheral neuropathy during the 3 months prior to enrollment.
5. Has known hypersensitivity to TAS-119 or its components.
6. Has known hypersensitivity to Cremophor® EL, paclitaxel or its components.
7. Is a pregnant or lactating female.
Using Transcranial Magnetic Stimulation (TMS) to Understand Hallucinations in Schizophrenia

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia.

TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.

This study tests the hypothesis that hallucinations in schizophrenia are mediated by network pathophysiology, and that network pathophysiology can be quantified by the functional connectivity of a cerebellar-thalamo-cortical circuit. To accomplish this, participants will be recruited who are diagnosed with schizophrenia or schizoaffective disorder who experience auditory hallucinations.

Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments of schizophrenia symptom severity. These assessments include reporter-based measures such as the Positive and Negative Syndrome Scale (PANSS).

Participants will then undergo an MRI scan that includes structural and resting-state functional magnetic resonance imaging (rsfMRI). These rsfMRI imagines will be used to isolate individual resting state networks for targeting of rTMS modulation.

Participants will then undergo five days of twice daily rTMS sessions.

One week after the last rTMS session, participants will undergo follow-up MRI imaging and the same study assessments.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

* substance use disorder in past 3 months
* ambidexterity
* contraindications for TMS or MRI including :
* history of neurological disorder
* history of head trauma resulting in loss of consciousness
* history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy
* metal in brain or skull
* implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt
* claustrophobic in MRI
A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

The objective of this study is to evaluate the safety and efficacy of the Bausch \& Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
* Subjects must be of Asian descent.
* Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.

Exclusion Criteria:

* Subjects who have any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or are using any ocular medication.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
* Subjects who currently wear monovision, multifocal, or toric contact lenses.
* Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.
A Study of a Device Used to Take Pictures of Skin Blood Flow

The purpose of this study is see fi the hyperspectral camera system (HCS) can measure skin blood flow (perfusion and oxygenation) in healthy people.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.
* Body mass index (BMI) between 18 to 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
* Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

* History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
* Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
* Use of any medications (prescription or over-the-counter \[OTC\]), vitamin, mineral, herbal, and dietary supplements within 21 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day). Other exceptions will only be made if the rationale is discussed and clearly documented between the Investigator and the sponsor.
* Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
* Smokers as defined by any of the following criteria:
* Reported smoking of cigarettes within 12 months prior to screening; occasionally a cigarette is allowed, but not within 24 hours of the measurement.
* Any confirmed significant allergic reactions (urticarial or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
* Unwillingness of inability to comply with the study protocol for any other reason.
Impact of Tooth Loss and Denture on Oral Senses and Food Preferences

Tooth loss impacts taste abilities and food intake. Present study aims at pertaining the impact of teeth loss and the replacement by means of complete denture on taste and trigeminal abilities, and on food preferences, and taste appetence.

Two groups of participants will be included. Participants wearing complete denture for at least one year (n=20) and their matched controls for age, sex, tobacco, and saliva secretion (n=20). Their oral sensory abilities of participants will be assessed including taste (electrogustometric thresholds, chemical taste identification ability) and trigeminal quantitative sensory testing. Food preferences and selectivity (Maitre et al., 2014) and taste appetence (Deglaire et al., 2012) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

Study Group : being completely edentulous and wearing denture for at least one year, wearing denture during meals, with clean and stable dentures. Controls:

controls Group : dentate subjects (25 teeth at leas, non endodontically treated) with molars in Angle's Class I occlusion, having no functional disturbance of mastication and not undergoing dental treatment at the time of the recording. Matched with subjects of the study group for age, sex, tabacco consumption, and saliva flow rate.

Exclusion Criteria:

* Aged under 18 or over 80 Y,
* not consenting to participate
* suffering from dental
* periodontal or gum pain for the last month.
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy

The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with exposure to at least 1 dose of Epidiolex/Epidyolex during the 13 days prior to their LMP or at any time during pregnancy.
2. Verbal or written informed consent to participate

Exclusion criteria:

1) Patients exposed to a non-regulatory approved product containing Cannabidiol (CBD) during pregnancy who do not also have exposure to Epidiolex during the 13 days prior to their LMP or during the pregnancy.
A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas

The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms.

This study is a retrospective, non-interventional and, post-authorization observational study of other designs (PAS-OD).

This multicenter trial will be conducted in Spain. Retrospective review of medical records and initial tumor biopsies of participants diagnosed with PTCL in the period of 6 years between 01/01/2008 and 31/12/2013 will be performed. Initial tumor biopsies and histological preparations, filed and previously anonymized, will be sent to the central laboratory for assessment.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/2013.
* Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm).
* PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms:

  * Natural killer/ T-lymphocytes (NK /T-cell) lymphoma extranodal nasal type
  * Enteropathic T-cell lymphoma
  * Hepatosplenic T-cell lymphoma
  * Peripheral T-cell lymphoma, not otherwise specified
  * Angioimmunoblastic T-cell lymphoma
  * Anaplastic large cell lymphoma, Anaplastic lymphoma kinase positive (ALK)+
  * Anaplastic large cell lymphoma, ALK-

Exclusion Criteria:

• Participants with an unavailable history (lost, empty or not recoverable).
Assessment of Severity and Prognosis for Patients With Status Epileptics(SE)

To characterize the functional outcomes and prognostic factors for convulsive status epilepticus (SE) and to further develop and validate a simple and practicable scoring system for outcome prediction.

1. Retrospectively study all patients with convulsive SE treated between March, 2008, and November, 2014.
2. Develop a scoring system for outcome prediction.
3. Prospectively validate the predictive accuracy of the scoring system

Eligibility Criteria:
Inclusion Criteria:

* 30 min or more of (1) continuous clinical seizure activities or (2) recurrent seizure activities without recovery(returning to baseline)between seizures;
* clinical data is complete.

Exclusion Criteria:

* hypoglycemia SE;psychogenic SE;any other pseudo-SE
Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication

The main purpose of this study is to compare the safety, effectiveness and tolerability of using Pegasys with Copegus in people who have both the hepatitis C virus (HCV) genotype 1 and HIV who continue taking HAART (highly active antiretroviral therapy) to those who discontinue taking HAART.

Canadian guidelines recommend that both HIV and HCV should not be treated at the same time as the medications needed to treat these two diseases may interact and that which disease to treat first is dependent on the CD4 count. In this study, the CD4 count must be over 350 cells and one must be stable on HAART before starting the study medication Pegasys in combination with Copegus.

Since the introduction of highly active antiretroviral therapies (HAART), liver disease secondary to HCV infection has become a leading cause of morbidity and mortality in HIV/HCV co-infection. The influence of HCV co-infection on the progression of HIV has been less clear and the results have been conflicting. Studies conducted in the pre-HAART era did not find that HIV/HCV co-infection influenced the progression of HIV-induced immunodeficiency or death. Of four large studies conducted after HAART was introduced, two suggested a faster progression of HIV disease in the presence of HCV co-infection and two found no influence of HCV co-infection on overall mortality or progression of HIV disease. HCV may also negatively influence HIV disease in indirect ways, such as making the discontinuation of antiretroviral treatment more frequent because of an increased risk of liver toxicity.The morbidity and mortality resulting from the rapid progression of HCV infection in HIV-co-infected patients, particularly given the advances in HIV treatment that have improved the life expectancy of HIV-infected patients, support treating HCV infection in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C genotype 1 infection·
* Detectable plasma HCV-RNA Roche\>1000copies/ml, \>600IU/ml
* Chronic liver disease consistent with CHC infection on a biopsy obtained within the past 24 months
* Patients with cirrhosis or incomplete cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP \<100 ng/mL within 2 months of randomization
* Patients with CD4 cell count ³ 350 cells /µL
* Patients on stable highly active antiretroviral therapy (HAART) for at least 12 weeks prior to baseline with the exception of patients receiving didanosine
* HIV-1 RNA is \< 5000 copies/mL

Exclusion Criteria:

* IFN, pegylated interferons, viramidine, levovirin, or ribavirin therapy at any previous time
* Patients with evidence of active hepatitis B infection. ( presence of HbsAg)
* History or evidence of decompensated liver disease and/or a Child-Pugh score \> 5, bleeding from esophageal varices, hepatic malignancy
* abnormal bloodwork ie absolute neutrophil \<1,Hbg \<110, Platelets \<70,creatinine \<50