cyrilzakka/clinical-trials huggingface dataset:
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_04

Participants will take part in both a passive and active emotion recognition task: (1) passively listening to semantically-neutral sentences with emotional prosody, and (2) actively listening and subsequently categorizing emotional sentences and sounds. Participants are seated and instructed to stare at a fixation cross while the stimulus is played. During this study, non-invasive physiological measurements of pupil dilation will be recorded from the participants. Using this paradigm we will be assessing the effect of frequency lowering on emotion recognition. The study takes the form of a partly three factorial design (passive task x frequency lowering x acclimatization). Participants also perform a two factor design (active task x frequency lowering). Each participant performs two passive tests (20 minutes long each) with frequency lowering on and off, and a four week acclimatization period in-between. Participants perform one active listening task after the acclimatization period with frequency lowering on and off.


Eligibility Criteria:
Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature
* Minimum 1 year hearing aid experience
* Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation

A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.


Eligibility Criteria:
Inclusion Criteria:

* age 18-75
* Karnofsky performance status \>50 or World Health Organization performance score \< 2
* primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)
* preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)
* lesion can be removed completely or residual disease \< 0.5 cm
* last chemotherapy finished no more than 12 weeks after surgery
* no hepatic function damage
* white blood cell count ≥3.5\*10\^9/L; platelet count ≥80\*10\^9/L; Hemoglobin ≥90g/L
* no contraindication of surgery and anesthesia
* life expectancy ≥ 3 months
* informed consent form signed

Exclusion Criteria:

* age \< 18 or \>75
* no history of other cancer
* platinum allergy
* distant metastasis
* used anti-angiogenic drug within 8 weeks
* possibility of more than two resection of alimentary canal
* recurrence \< 6 months after primary treatment
* histologic type: non epithelial origin
* infection out of control
* follow-up unable to carry on (geographic or psychic)
* cardiac insufficiency or respiratory insufficiency
* has received HIPEC already
* being in other clinical study
* pregnancy or lactation period
Effects Of Muscle Energy Technique Versus Mobilization

The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain

The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain in postpartum females and to check whether the amount of gaining range of movement is similar among postpartum female undergoing with mobilization therapy and with muscle energy technique.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 year having unilateral back pain around or on sacral sulcus,
* Positive posterior pain provocation test for Sacroiliac joint dysfunction,
* Low back pain within six weeks of delivery
* Pain while sitting down, lying on the ipsilateral side of pain, or climbing stairs.
* Local tenderness of the posterior aspect of the sacroiliac joint
* Pain is usually localized over the buttock.
* Sharp, stabbing, and/or shooting pain which extends down the posterior thigh usually not past the knee.
* C-section

Exclusion Criteria:

* Neurological deficit
* Spinal tumors
* Scoliosis,
* Underwent spinal surgery and prolapsed
* Intervertebral disc with or without radiculopathy
Trial Comparing Best Supportive Care to Aloe Vera Gel

Radiation therapy (RT) has been a component of breast cancer treatment for almost 100 years. Although initially used for the treatment of chest wall recurrences after mastectomy and for advanced inoperable disease, RT has evolved into a critical component of early therapy for women with an intact breast following lumpectomy and for mastectomized women who are at high risk for local failure. Currently breast cancer patients need a multidisciplinary management including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in loco regional control of the disease. It is estimated that 87% of these women will develop some degree of radiation-induced dermatitis, varying from mild to brisk erythema or even moist desquamation.

Topical agents, such as corticosteroid creams and other products including Aquaphor (Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning of radiotherapy.

The aim of this randomized phase III study was to assess the effectiveness of aloe vera cream for the prevention of acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer, compared to best supportive care. The secondary objectives were to assess pain, treatment interruption as a result of skin reactions, and the quantity of life during the treatment.


Eligibility Criteria:
Inclusion Criteria:

* The women had to be 18 to 75 years of age with a nonmetastatic breast adenocarcinoma treated by either lumpectomy or mastectomy with or without adjuvant postoperative chemotherapy or hormonal treatment, and referred to the Department of Radiotherapy for postoperative radiotherapy. Concomitant chemotherapy was allowed.

Exclusion Criteria:

* Women with bilateral cancer, patients who were allergic to either of the two agents, and pregnant women were excluded.
* No rash, ulceration, bleeding, or unhealed scar was allowed in the treatment area.
* Patients were excluded for: prior radiation therapy (RT), mastectomy, skin involvement by tumor, history of, or current connective tissue disorder, medical contraindication (allergy or sensitivity) to Aloevera or planned BSC, and inability to comply with treatment regime. The use of bolus was prohibited.
Comparison of Combined Spinal-epidural Analgesia Versus Epidural Analgesia for Pain Management During Labor

The investigators want to compare the safety and efficacy between the combined spinal-epidural analgesia and epidural analgesia during labor.

Participants who request neuraxial labor analgesia are randomized to receive combined spinal-epidural analgesia or epidural analgesia during labor. The investigators collect the data on the duration of three stages of labor, the mode of delivery, neonatal Apgar scores, VAS scores, modified Bromage scores.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women at term (37 to 42 weeks of gestation), vertex presentation, singleton pregnancy who desired vaginal delivery were eligible to participate.

Exclusion Criteria:

* Contraindications to neuraxial techniques such as clinically significant coagulopathy and increased intracranial pressure, and patients with preterm labor, multiple pregnancies, non-vertex presentation, cephalopelvic disproportion and severe obstetric complications
A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.

Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this trial if you:

* Have HIV infection.
* Have levels of CD4 cells of 100 cells/mm3 or greater.
* Have a viral load of 10,000 copies/ml or greater.
* Are 18 years of age or older.

Exclusion Criteria

You may not be eligible for this trial if you:

* Have ever taken anti-HIV drugs.
Low Sirtuin-1 Levels Are Linked to Erythropoietin Resistance in Hemodialysis Patients.

This study investigates the relationship between Sirtuin-1 (SIRT1) levels and erythropoietin resistance in hemodialysis patients. The study aims to determine whether low SIRT1 levels contribute to EPO resistance and to explore the potential mechanisms involved. Blood samples and clinical data from hemodialysis patients will be analyzed to evaluate this relationship.

This study explores the association between Sirtuin-1 (SIRT1) levels and erythropoietin resistance in hemodialysis patients. Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in chronic kidney disease (CKD) patients undergoing hemodialysis. However, a significant proportion of patients exhibit hyporesponsiveness to ESAs, leading to suboptimal anemia management. SIRT1, a nicotinamide adenine dinucleotide (NAD+)-dependent histone deacetylase, regulates hypoxia and iron metabolism by modulating the activity of hypoxia-inducible factor 1α (HIF-1α). Lower SIRT1 levels may impair HIF-1α activity and contribute to reduced erythropoietin (EPO) responsiveness.

In this multicentric cross-sectional cohort study, 391 adult hemodialysis patients from provincial dialysis clinics in Bursa, Turkey, were enrolled between August 2020 and March 2021. ESA responsiveness was assessed using the Erythropoietin Resistance Index (ERI), calculated as the weekly weight-adjusted ESA dose divided by hemoglobin concentration. Serum SIRT1 levels were measured using a human SIRT1 ELISA kit.

The study aims to determine whether low SIRT1 levels are independently associated with higher ERI scores and to identify other clinical and biochemical parameters influencing ESA responsiveness. Multiple regression and correlation analyses will be performed to evaluate the relationship between SIRT1 levels, ERI scores, ferritin levels, and other clinical factors. Logistic regression will also be conducted to explore whether SIRT1 is an independent predictor of high ERI scores (≥50th percentile).

The findings from this study may provide new insights into the molecular mechanisms underlying ESA resistance and highlight the potential role of SIRT1 as a target for improving anemia management in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Receiving hemodialysis
* Availability of laboratory data to calculate ERI

Exclusion Criteria:

* Autosomal polycystic kidney disease
* Malignancies
* Infectious diseases
* Chronic rheumatological disorders
* Vitamin B12 or folic acid deficiency
* CRP levels ≥ 5 mg/L
* PTH levels ≥ 300 pg/dL
* Inadequate hemodialysis (Kt/Vurea \< 1.2)
Perception and Equilibrium After Cochlear Implantation

The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.

The usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture.


Eligibility Criteria:
Inclusion Criteria:

* Profound deaf patients who are scheduled for a cochlear implantation
* Patients gave their written informed consent
* Patients are affiliated to the french social welfare

Exclusion Criteria:

* Disorders from the motor and/or somesthetic systems (especially the lower limbs)
* Contraindications to the scheduled functional assessments
A Wearable System to Monitor Tai Chi Practice

The goal of this research study is to show that features derived from data gathered using SHIMMER wearable sensor platform can capture adherence and proficiency in the performance of exercises that are part of Tai Chi interventions.


Eligibility Criteria:
Inclusion Criteria:

* Young style Tai Chi practitioners

Exclusion Criteria:

* Any movement impairment that will impede Tai Chi movements performance
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. 45 - 80 years old (at time of informed consent)
2. Male or female (females of childbearing potential must be contracepted)
3. Confirmed acute coronary syndrome

Exclusion Criteria:

1. Unwilling or unable to provide informed consent
2. History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder
3. Recent trauma or major surgery
4. Evidence of active pathological bleeding at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
5. History of intracranial bleeding or history of hemorrhagic retinopathy
6. History of New York Heart Association (NYHA) class III or IV congestive heart failure
7. Pregnant or lactating women
Multiparametric Image Analysis and Correlation With Outcomes in Lung Cancer Screening and Early Stage Lung Cancer

Determine whether CT-based multiparametric analytical models may improve prediction of biopsy and treatment outcome in patients undergoing screening CT scan and/or treatment for early stage lung cancer

The hypothesis is that multiparametric models that incorporate complex image information from screening CT scans will improve prediction of the outcome of subsequent lung biopsy, an invasive diagnostic procedure. In this project, we will construct an image feature-based multiparametric prognostic model for biopsy outcome from screening lung CT scans performed at our institution, and then validate it using theNLST imaging and clinical outcomes dataset.

This study involves no treatment or invasive procedures. Investigator will review all charts of patients who were treated for early stage lung cancer with definitive radiation therapy at UTSW or Parkland Memorial hospital, diagnosed with a malignancy from January 1, 2004 to October 31, 2014, to compile demographic, diagnostic, therapeutic, outcome, and toxicity data. Investigator expect that this will include approximately 200 patient charts. This data will be analyzed statistically and used for future directed research. Investigator will also analyze an anonymized dataset of patients from the National Lung Cancer Screening Trial (NLST) provided by the National Cancer Institute (NCI)

Eligibility Criteria:
Inclusion Criteria:

Patients that have been diagnosed with lung cancer, and are treated at Department of Radiation Oncology, UTSW or Parkland Memorial Hospital.

Exclusion Criteria:

There will be no absolute exclusion criteria as long as the inclusion criteria have been met.
Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma.

The ACO-ASSO (Austrian Society of Surgical Oncology) colorectal group and Austrian Working Group for Coloproctology present the LARS Austria study. It is a prospective, multicenter observational study. The primary objective of this study is to collect information about LARS (LARS score) and QoL (EORTC -CR29) in patients with non-metastatic rectal cancer who received therapy. As a secondary objective, the impact of radiotherapy on the occurrence of LARS will be investigated.

All consecutive patients with biopsy verified rectal cancer (≤16cm from anocutaneous line) can be included in the study. For the study, tumors whose aboral margin, when measured with a rigid rectoscope, is 16 cm or less from the anocutaneous line will be included. Thus, only histologically verified tumors of the lower (\<6 cm), middle (6\<12 cm) and upper (12-16cm) rectal thirds are included.

Patients will be included after the indication for further therapy has been established in the tumor board according to guideline criteria and after signing the participation consent. The collection of study relevant data will be performed according to the following scheme:

Group 1 = patients without neoadjuvant radiochemotherapy (RCHT). Collection of data and questionnaires before surgery and 3, 6, and 12 months after index surgery (if no protective stoma).

OR Collection of data and questionnaires before surgery and 3, 6, or 12 months after stoma re-operation (if protective stoma).

Group 2 = patients with neoadjuvant RCHT/ definitive RCHT=watch and wait. Collection of data and questionnaires before RCHT and before surgery or after RCHT and 3, 6, or 12 months after index surgery (if no protective stoma).

OR Collection of data and questionnaires before RCHT and before operation=surgery(OP) or after RCHT and 3, 6 or 12 months after stoma closure (if protective stoma) OR Collection of data and questionnaires before RCHT and 3, 6 and 12 months after RCHT (if no surgery)

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 99 years
* Patients with biopsy-verified rectal cancer.
* Patients scheduled for elective sphincter-preserving rectal surgery
* Patients scheduled for neoadjuvant RCTx (Chemo-radiation) (concept: short course radiation, conv.

fractionated RCTx, total neoadjuvant therapy(TNT))

* Signed consent (ICF)

Exclusion Criteria:

* Patients younger than 18 years
* Patients without signed informed consent
* Metastatic carcinoma
* terminal colostomy ( APR (abdominoperineal resection),...)
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.


Eligibility Criteria:
Major Inclusion Criteria:

* male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
* experiencing a current major depressive episode

Major Exclusion Criteria:

* any subject unable to provide informed consent
* any female subject who is pregnant or breast-feeding
* any subject judged to be medically inappropriate for study participation
Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging

The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.


Eligibility Criteria:
Inclusion Criteria:

* 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning

Exclusion Criteria:

* known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.