cyrilzakka/clinical-trials huggingface dataset:
Speech Locator_Benefits in Pediatric Popluations

The study seeks to evaluate the impact of SpeechSensor and StereoZoom 2.0 on speech understanding in noise in dynamic listening conditions in pediatric hearing aid users.

The purpose of this study is to substantiate clinical performance claims regarding the benefit of the SpeechSensor feature on speech recognition in noise for side and rear speech as well as StereoZoom 2.0 benefit data for front speech in noise. In addition, the study will yield myPhonak app usability data and claims regarding children's impressions (confidence, anxiety) when given the opportunity to personalize their beamformer settings in noise during a home trial. Finally, this work will confirm hearing aid intended use for pediatric hearing aid users. Results will inform feature setting, provide critical post-market clinical hearing aid data and support for claims.

Eligibility Criteria:
Inclusion Criteria:

* Experienced (\> 6 months), full-time hearing aid user
* 10 years up to but not including 18 years of age
* Spoken English
* Ability to understand oral instruction
* Ability to describe listening experiences
* No known neurological issues or cognitive impairment
* Ability to attend the in-person appointment(s)
* No speech/language deficits that could compromising ability to perform tasks
* Healthy outer and middle ear
* Hearing loss consistent with fitting range of the investigational product
* Access to a smartphone that can be used during a home trial
* Informed consent (signature) of parent and consent or assent (verbal) of child

Exclusion Criteria:

* Clinical contraindications (e.g., closed ear canal, absence of pinna)
* Known hypersensitivity or allergy to materials comprising hear-ing aid or acoustic coupling
* Unwilling to wear the hearing aid
* Unwilling or not permitted to use a smartphone
* Aided open-set aided speech recognition scores for speech front (+15 dB SNR) \< 30%
Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses

The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis
* Rheumatoid arthritis
* Avascular necrosis (AVN) of bone
* Other inflammatory arthritis
* Post-traumatic arthritis
* Juvenile rheumatoid arthritis

Exclusion Criteria:

* Prior ipsilateral TKA
* Metabolic disorders
* Joint replacement due to autoimmune disorders
* History of recent/active joint sepsis
* Charcot neuropathy
* Psycho-social disorders that would limit rehabilitation
* Greater than 75 years of age at the time of surgery
* Severe diabetes mellitus
* Skeletal immaturity
Impact of a Previous CS on the Ongoing Pregnancy Rate in Single Euploid Frozen Embryo Transfer (ET)

As embryo ploidy is a crucial factor not only for implantation but also for maintenance of a pregnancy, the aim of this study is to evaluate the impact of the CS / isthmocele on the ongoing pregnancy rates and the implantation site in single euploid frozen embryo transfer, independent of the endometrial preparation approach.

The impact of a previous CS on the future fertility in the general population is discussed controversially, but it seems that the clinical and social circumstances leading to the CS have a greater effect on future fertility than the surgical procedure itself (Gurol-Urganci et al., 2013, 2014; Evers et al., 2014). However, this might be different in women who do not conceive spontaneously after a previous CS and need to undergo ART due to secondary infertility. Whereas some studies describe a reduction of implantation, ongoing pregnancy, and live birth (LB) rates (Vissers et al., 2020; Wang et al., 2020; Diao et al., 2021; Friedenthal et al., 2021; van den Tweel et al., 2022), others describe a negative impact of a previous CS only in the presence of an isthmocele (Diao et al., 2021) or no impact (Patounakis et al., 2016).

A case control study evaluated whether there are any differences in the location and distance to the internal cervical ostium of the implantation site of the intrauterine gestation sacs, early pregnancy symptoms and pregnancy outcome at 12 weeks gestation between women with and without a previous Caesarean section (CS) in patients who conceived naturally (Naji et al., 2013). Investigators concluded that the presence of a CS scar affects the site of implantation, and also that the distance between implantation site and the scar is related to the risk of spontaneous abortion.

This is a purely observational study without any intervention. Participants will be stratified into different groups according to their previous obstetrical history. Total sample size will include 1050 participants undergoing a frozen embryo transfer (FET) cycle.

Isthmocele will be defined according to de Vaate et al (Bij de Vaate et al., 2011) as: visible anechogenic area of at least 1 mm depth at the site of the Cesarean scar.

Eligibility Criteria:
Inclusion Criteria:

- All participants undergoing a single euploid FET, independent of the endometrial preparation approach

Exclusion Criteria:

* Intracavitary fluid during preparation for FET
* Known anomaly of the uterus or the adnexae (e.g.: fibroids, polyps, hydrosalpinx, endometriosis, adenomyosis)
* Embryo which was biopsied on day 7
* Poor quality embryo which was transferred (Gardner criteria: AC / BC / CB, biopsied on day 6 and CC embryos from both, day 5 and day 6 biopsies, classified as "poor" quality embryos)
* History of recurrent abortion
* Antiphospholipid syndrome / autoimmune diseases
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

Primary: To determine the efficacy of early treatment with zidovudine (AZT) in HIV-infected asymptomatic infants. To determine the safety and tolerance of AZT in this patient population.

Secondary: To compare the virologic and immunologic parameters between the treatment groups. To determine the efficacy of AZT as an early treatment to prevent development of CD4+ cell depletion in HIV-infected asymptomatic infants.

AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.

AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.

Patients are randomized to receive oral AZT (at age-adjusted doses) or placebo. Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter; those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive. Patients who meet the criteria for changes to open-label AZT will be given the appropriate age-adjusted dose without unblinding the original randomization assignment. Patients who complete or discontinue treatment are followed every 6 months for up to 2 years.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 count \>= 2000 cells/mm3 AND \>= 30 percent of total lymphocytes.
* No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted).
* Consent of parent or guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Serious acute infection requiring parenteral therapy at time of entry.
* One or more serious, proven bacterial infections including any of the following:
* septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria.
* Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile.

Concurrent Medication:

Excluded:

* Any agent with known antiretroviral activity.
* Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously.

Prior Medication:

Excluded:

* More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally.

Recommended:

* PCP prophylaxis.
* Immunizations according to current recommendations.
Comparison of Autogenic and Allogenic NK Immunotherapy on the Outcome of Recurrent Solid Tumors

The aim of this study is the efficacy of autogenic and allogenic natural killer (NK) immunotherapy on recurrent solid tumors.

By enrolling patients with multiple kinds of solid tumor adapted to enrolled criteria, this study will document for the first time the short/long term efficacy of auto/allogenic NK cells.The outcome will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital

In developing countries, electroconvulsive therapy (ECT) is typically delivered without the use of an anesthetic prior to the treatment, known as unmodified ECT. This interventional study aims to decrease the practice of unmodified ECT at Chhatrapati Shahuji Maharaj Medical University, U.P. \& G.M. \& Associated Hospitals (C.S.M) by administering a low dose anesthetic (propofol) prior to ECT delivery. In so doing, the investigators hope to facilitate the transition from unmodified to modified ECT without incurring excessive costs to the center. It is hypothesized that ECT patients will opt for modified treatment, that adverse effects will be minimal, and that costs will not rise prohibitively.

Patients that are currently receiving unmodified ECT at C.S.M Hospital will be eligible for the first phase of the study in which only data is collected. Three months after study start, patients who are to receive ECT for a psychiatric disorder will be eligible to participate in the intervention (introduction of propofol at a low dose prior to ECT). Data collection will include information such as demographics, ratings scales, seizure length, anxiety level, adverse events, and number of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are any psychiatric patients at C.S.M. for whom ECT is recommended by their doctor, whether or not they actually receive ECT.
* Subjects must also have an American Society for Anesthesiologists (ASA) rating score of 1 (completely healthy) or 2 (mild systemic disease) with stable symptoms and laboratory values.
* Subjects must be between the ages of 18 to 65 years old and be able to give informed consent.

Exclusion Criteria:

* Patients who speak neither English nor Hindi.
* History of or anatomical evidence for a difficult airway being a short mandible, micrognathia, large tongue or large goiter, arthritis of the jaw or neck, or enlarged tonsils. For this reason we will also exclude patients with a BMI \> 28.
* Respiratory tract disease including asthma, respiratory infection, chest wall disease, chronic obstructive pulmonary disease, obstructive sleep apnea, or other disorder which might compromise the airway. Patients who smoke 15 or more cigarettes per day will be excluded unless abstinent for at least 10 days, to reduce the risk of respiratory complications.
* Patients who receive modified ECT during the first phase of the study.
* Pregnant women or women who are breastfeeding.
* Hypersensitivity to propofol or any of its components.
* Patients who are hemodynamically unstable or who have impaired cardiac function.
* BMI \< 18.
* Patients with a history of epilepsy
A Dose-Escalation Study of RO5083945 in Patients With Metastatic and/or Locally Advanced Malignant Epidermal Growth Factor Receptor (EGFR)+ Solid Tumors.

This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* centrally confirmed EGFR expression in tumor tissue;
* radiologically measurable or clinically evaluable disease;
* last dose of systemic anti-neoplastic therapy or radiotherapy \>=28 days prior to start of study;
* histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ solid tumors (Part 1);
* histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ and mutant KRAS colorectal cancer (Part 2);
* not more than 2 previous cytotoxic regimens for metastatic disease (Part 2).

Exclusion Criteria:

* history of grade 3-4 toxicity resulting from previous anti-EGFR treatment;
* known or suspected CNS metastases;
* wild type KRAS colorectal cancer (Part 2).
Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B

Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate.

Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Written consent to release patient information
* Living or deceased patients with mild to severe hemophilia B who have had at least 1 exposure to replacement factor IX product(s).
* Living or deceased patients who had their first infusion of any FIX product between 1 January 1991 and 31 December 2003.

Exclusion Criteria:

* There are no exclusion criteria.
DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer

The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in patients with metastatic and/or recurrent breast cancer who may have received previous hormone treatment but have not had exposure to anthracycline treatment. Stratification allocation will be within the following subgroups:

1. Prior cytotoxic treatment;
2. Estrogen receptor status;
3. ECOG performance status;
4. Number of cycles of chemotherapy.

Endpoints of the trial are as follows:

primary: overall survival; secondary: response rate, progression free survival, toxicity, neurocognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Histological proof of breast cancer
* Documented evidence of metastatic and/or recurrent breast cancer
* Presence of at least one bi-dimensional or uni-dimensional lesion
* ECOG status 0, 1 or 2
* Quality of life
Dilapan-S Osmotic Dilator in Pre-induction of Labor

Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section. The evaluation will be based on prospective data collection in at least four obstetrics centers in the Czech Republic.

Nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. Dilapan-S is a hygroscopic uterine neck dilator. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of Dilapan-S sticks which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on endocervical structures also stimulates the production of endogenous prostaglandins, which promote cervical ripening through its collagenolytic action. Although Dilapan-S is widely used in labor pre-induction, published study data comparing its clinical efficacy and safety in females with/without caesarean section in medical history are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Single pregnancy
* Pregnancy more than 36 weeks
* Vertex presentation of the fetus
* Cervix Score less than 4 points

Exclusion Criteria:

* Contraindication to vaginal delivery
* Pathological fetal station
* States after uterine body surgery - except for Caesarean section
* Clinical signs of uterine, vaginal or vulvar infection
* Fetus hypoxia (KTG recording evaluated as pathological prior to pre-induction initiation)
Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8

A randomized controlled trial of a technology-based lifestyle intervention vs. usual care among men with low-risk prostate cancer to determine the feasibility and acceptability of the intervention and the effect of the intervention on behavior change related to exercise, diet, and not smoking.

This is a PI-initiated, randomized, unblinded, clinical trial of a technology-based 3 month lifestyle intervention vs. usual care among men with low risk prostate cancer. We will recruit and consent 76 men with prostate cancer at UCSF. The subjects will be asked to complete questionnaires, 7 days accelerometer measurement, body measurements (weight, waist, hip, pulse, blood pressure) and collection of blood specimen at baseline and 3 months. Subjects will be randomized into two arms (Intervention Group and Control Group). The Intervention Group (N=38) will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive text messages, and be provided with individualized lifestyle recommendations. The Control Group (N=38) will have standard of care and be asked to continue with their usual lifestyle habits. They will receive access to the lifestyle website and be provided with individualized lifestyle recommendations at 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. clinical stage ≤T3a nonmetastatic prostate cancer within 5 years
2. completion of treatment ≥3 months prior to enrollment, if not on active surveillance
3. ability to walk unassisted
4. be able to speak and read English
5. ability to navigate websites and email, and have internet access
6. able to travel to UCSF for pre- and post-study blood collection

Exclusion Criteria:

1. any contraindications to moderate or vigorous aerobic exercise
2. psychiatric condition preventing the patient from giving informed consent or adhering to the study protocol
3. reporting adherence to more than 4 of the 8 targeted lifestyle behaviors via questionnaires at screening
Body Composition Analysis in Patients Undergoing Chemoembolization

Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of patients with hepatocellular carcinoma are associated with cirrhosis.

Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into the hepatic tumor where the principal artery is embolized.

Bioelectrical impedance bases its evaluation in a model where the body is conformed by two different compartments: fat mass and fat free mass.

Bioelectrical impedance is complemented by vectorial analysis, which is independent to the state of hydration and is helpful to monitor any changes in corporal composition. It can be used as a control for the interpretation of the bioelectrical impedance.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepato-renal disease
* Patients with hepatocellular carcinoma that are put down to radiofrequency ablation
* Patients with depression or any psiquiatric disease.
* Patients that don't agree to participate in the project.

Exclusion Criteria:

* Patients with hepatocellular carcinoma that are put down to radiofrequency ablation
* Patients with depression or any psiquiatric disease.
* Patients that don't agree to participate in the project.
Effectiveness of Transcranial Direct Current Stimulation for TKR

Transcranial direct current stimulation (tDCS) is a technique of noninvasive cortical stimulation allowing significant modification of brain function used. Clinical application of this technique could be helpful for pain, Parkinson's disease, dystonia, cerebral palsy and dementia etc. And tDCS is safe with only mild, transient adverse effects. But there is few studies focused to postoperative states.

The aim of this project is to reveal the effect of tDCS for postoperative pain after total knee replacement surgery,


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have scheduled elective spine surgery.

Exclusion Criteria:

* Who has Cognitive dysfunction before surgery.
* Who already has delirium before surgery.
* Who has pain disorder ( like CRPS)
* Who cannot reveal the one's pain.