cyrilzakka/clinical-trials huggingface dataset:
Speech Perception for Children With Cochlear Implants

The purpose of this study is to determine whether speech recognition in noise can be improved by the addition of a special listening program to the sound processor. Thus we propose to assess speech perception in noise for pediatric cochlear implant patients using both their everyday listening program as well an ASC program.

The purpose of this study is to determine whether speech recognition in noise can be improved by the addition of a special listening program to the sound processor. Thus we propose to assess speech perception in noise for pediatric cochlear implant patients using both their everyday listening program as well an ASC program.

You will be asked to listen to sentences in quiet and in noise and repeat the sentences. You will be seated in a comfortable chair inside the sound booth with 8 loudspeakers placed in a circular pattern around your head. We will test your sentence recognition abilities in your listening program as well as in the new listening program. The sentences and noise will be presented through loudspeakers at levels typically encountered in everyday communication environments. Your participation would involve approximately 20 minutes of testing plus 10 minutes to add the new listening program to their processor.

Eligibility Criteria:
Inclusion Criteria: Children with bilateral sensorineural hearing loss who have 1) one or two Nucleus 24 series cochlear implants, 2) at least 1 year experience with their cochlear implant, and, 3) the ability to score \> 50% correct for HINT sentences in quiet.

Exclusion Criteria: 1) Patients under 4 years of age or over 17 years of age, 2) patients who have had at least 1 year experience with their cochlear implant and, 3) patients who score \> 50% for HINT sentence recognition in quiet
A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence

The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP).

BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States.

Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participant meets the following criteria:

  * Bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) (identical grades for left and right sides of the face), as determined at by the investigator using the Masseter Muscle Prominence Scale (MMPS).
  * Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined by the participant using the Masseter Muscle Prominence Scale - Participant (MMPS-P).
  * Investigator and participant scoring of MMPS and MMPS-P must be the same.
* Body mass index (BMI) ≤ 30 kg/m\^2 using the calculation: BMI = weight (kg)/height (m)\^2.

Exclusion Criteria:

* Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading.
* Asymmetry of left and right sides of the face that could prevent identical MMPS or MMPS-P grading on both sides of the face.
* History of or current temporomandibular disorder (TMJD), or presence of signs/symptoms of possible TMJD.
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients

This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who successfully completed Study A3921030

Exclusion Criteria:

* Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants
Repositioning Method for Left-sided Double Lumen Tubes

The purpose of this study is to devise repositioning method of a left-sided double lumen tube into left mainstem bronchus in case of misplacement into right mainstem bronchus.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery that requires the placement of left-sided double lumen tubes

Exclusion Criteria:

* intraluminal lesion of left bronchus
* very distorted anatomy of tracheobronchial tree
AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Men or post-menopausal or surgically sterile women, aged 18 to 55 years
* Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
* Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma

This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry
3. The expressions of both CD4 and CD8 are negative in patients with bone marrow involved
4. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
5. The main organ functions need to meet the following conditions:

   A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2.5 upper limitation of normal D.T-BIL≤2.0mg/dl E.SpO2 \> 90%
6. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
7. Expected survival exceeds 3 months
8. Written informed consent could be acquired

Exclusion Criteria:

1. Immunosuppressant medications or steroids were used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
2. Patients with uncontrolled active infection
3. Active hepatitis B or hepatitis C infection
4. Patients with HIV infection
5. Severe acute or chronic graft-versus-host disease (GVHD)
6. Participated in any other drug research clinical trials within 30 days before enrollment
7. Prior CAR-T cells therapy within 3 months before enrollment
8. Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment
9. Uncontrolled other tumor
10. Women in pregnancy, lactation or planning to become pregnant
11. The researcher considers inappropriate to participate in this research
A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)

This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Participant has Type 2 Diabetes (T2DM)
* Participant is either: Not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists
* Participant has not received insulin for at least 6 months
* Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks
* Participant has been a nonsmoker for at least 6 months
* Female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods

Exclusion Criteria:

* Participant has a history of stroke, seizures, or neurological disorders
* Participant cannot tolerate insulin or propranolol
* Participant has a history of asthma, emphysema or chronic bronchitis
* Participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening
* Participant is on or may require treatment with drugs that affect the immune system or with corticosteroids
* Participant has a history of heart failure or coronary artery disease
* Participant has a history of uncontrolled high blood pressure
* Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive
* Participant has a history of Type 1 diabetes
* Participant has a history of hypoglycemia unawareness documented by a blood glucose concentration \< 55 mg/dL (3.1 mol/L) without symptoms of hypoglycemia.
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE

This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected patients who actively use illicit substances. The study will also evaluate retention in care and adherence to B/F/TAF by self-report and pharmacokinetic analysis.

This is a single-center, single-arm, prospective, pilot study to evaluate the effectiveness and safety of B/F/TAF in viremic HIV-1 infected treatment naive or experienced patients with active illicit substance use outside of nicotine, alcohol, and marijuana use.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* Treatment naive or experienced
* Self-reported illicit substance use or confirmed urine drug screen within past 6 months of any of the following: cocaine, heroin, methamphetamine, MDMA, phencyclidine, ketamine, gamma hydroxybutyrate, cathiniones, or inappropriate prescription opiate, benzodiazepine or stimulant use (excluding nicotine, alcohol, marijuana for criteria)
* HIV RNA \>1000 copies/mL
* Creatinine clearance \> 30 mL/min (Cockroft-Gault)
* ALT and AST \< 5 times the upper limit of normal
* Willing and able to provide written informed consent

Exclusion Criteria:

* History of integrase or tenofovir related HIV resistance mutations
* Pregnancy
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with:

  * CLL or SLL and have received treatment with the following five classes of therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody, covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2) inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor
  * MCL that has been previously treated with a covalent BTK inhibitor
  * Richter's Transformation (RT) with previous Richter's directed-therapy
  * Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy, anti-CD20 antibody and a covalent BTK inhibitor
* Are not eligible for an ongoing pirtobrutinib clinical trial

Exclusion Criteria:

* Inadequate organ function
* Significant cardiovascular disease
* History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified Tcell (CAR-T) therapy within 60 days
* Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B or C virus or cytomegalovirus (CMV) infection
* Active, uncontrolled autoimmune cytopenia
* Clinically significant active malabsorption syndrome
* Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma

The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.

Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
3. Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
4. Measurable disease as per RECIST v 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy of at least 3 months.
7. A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate.
8. A female patient is eligible if not pregnant, not breast feeding, and not a woman of childbearing potential (WOCBP), or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment.

Exclusion Criteria:

1. Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
2. Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
3. Clinically significant cardiovascular disease
4. Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
5. Current active liver disease due to hepatitis B
6. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.
The Prevalence of a Low Ankle-Brachial Index in Acute Cerebral Ischemia.

Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.

The low ABI is a strong marker of generalized atherosclerosis. LEAD is a strong independent predictor for stroke.

Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.

The ABI is a non-invasive tool useful for the diagnosis of LEAD. The low ABI is a strong marker of generalized atherosclerosis. LEAD is a strong independent predictor for stroke. Significant ICAS is prevalent among patients having LEAD. Acute ischemic stroke due to significant ICAS has poor prognosis.

Patients with LEAD may be a suitable subgroup for screening for ICAS using duplex scanning.

Estimating the relationship between cerebral ischemic event and the ABI value could help better guide preventive and risk reduction strategies.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke or transient ischemic attack of anterior circulation
* Consent of patient

Exclusion Criteria:

* primary intracranial hemorrhage,
* venous sinus thrombosis,
* unconsciousness,
* intubation,
* inability to provide and write a consent application form.
Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery

Remote Ischemic Preconditioning (RIPC) is mediated by intermittent brief episodes (5-10 minutes) of short ischemia in a limb (i.e. arm), followed by reperfusion. For this purpose in 3-4 cycles, a tourniquet is insufflated to suprasystolic pressure levels for 5 minutes and deflated for 5 minutes afterwards. The ischemic episodes are known to stimulate platelets and factors platelet dependent factors such as Serotonin and VEGF. These humoral factors have a systemic effect and have the potential to protect target organs (i.e. heart, kidney, liver) remote to the ischemic limb.

The purpose of this randomized controlled study is to investigate the influence and impact of RIPC on postoperative complications in patients undergoing visceral surgery


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Undergoing major visceral surgery

Exclusion Criteria:

* \< 18 years
* Pregnancy
* Signs of Infection/Inflammation on upper limb
* Shunt
* Medical history of axillary lymph node dissection
* Signs of malperfusion of upper limb (i.e. Allen Test)
* Missing informed consent
Pulsed Dye Laser for the Psoriatic Nail

The treatment options for nail psoriasis have been limited, and the management of nail psoriasis has been challenging for physicians.To evaluate the effect of pulsed dye laser (PDL) in the treatment of nail psoriasis.

Psoriatic nails of patient's right hand were treated using PDL (595 nm) .The pulsed duration is 1.5ms, the beam diameter is 7mm, and the laser energy is 8.0 to 10.0 J/cm2. The treatment course of pulse dye laser is once monthly for 6 months. Psoriatic nails of both hands are treated with Tazarotene cream for 6 months. Clinical efficacy is statistically evaluated according to Nail Psoriasis Severity Index (NAPSI) score differences between right and left hand one month after 3rd and 6th therapy.

Eligibility Criteria:
Inclusion Criteria:

* Psoriatic nail refractory to other topical and systemic treatment therapy
* ≧ 16 years old

Exclusion Criteria:

* Patient with pregnancy
* Patient with photo sensitivity
* Patient with severe wound around finger nails or paronychia
* Patient with hypersensitivity to Tazarotene cream
Effects of Narratives on Demand for Low and High Ventilated Cigarettes and Substitution for Alternative Products

This study will investigate the effects of narratives on demand for low and high ventilated cigarettes and substitution for alternative products in the Experimental Tobacco Marketplace.

An important aim of tobacco control is to reduce demand for the most harmful products. One product feature that could be changed to benefit public health is cigarette filter ventilation. A recent review examined the effects of cigarette filter ventilation and concluded that filter ventilation, by changing how a cigarette burns, yields more mutagens and carcinogens, and results in greater puff volume and possibly depth of inhalation, which has led to increases in peripheral lung adenocarcinomas. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to compare the impact of a narrative and a factsheet on the negative consequences of filter ventilation on tobacco product purchases. High-ventilated cigarette smokers will complete multiple scenarios in the ETM.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Be at least 21 years of age or older
* Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
* Stable tobacco use patterns for at least three months
* Be willing to sample the study cigarettes (high- and low-ventilated cigarettes)
* Report smoking a high-ventilated cigarette (\>= 20% ventilation)
* Report smoking at least 10 cigarettes per day

Exclusion Criteria:

* Have plans to move out of the area
* Have a serious or unstable physical or mental health condition
* Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement
* Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study
A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors

The purpose of this study is to determine the efficacy and safety of two new patterns of controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study will be performed in egg donors but these new patterns will be implemented in fertility preservation patients.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal women 18-30 years old, with FSH levels \< 10mIU
* irregular menstrual cycle
* BMI between 12-28
* signed inform consent

Exclusion Criteria:

* Polycystic ovarian syndrome, gonadotropins allergy