cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of the Effect of Dysport and Botox

The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.


Eligibility Criteria:
Inclusion Criteria:

* age between 30 and 70 years
* moderate to severe hyperfunctional forehead wrinkles at maximum contraction and at rest

Exclusion Criteria:

* application of botulinum toxin products for a period of 12 months prior to the study
* any significant health disturbances
* facial nerve palsy, and any facial conditions that could confound safety or efficacy results
* pregnancy and breast-feeding
* neuromuscular diseases
* drugs interfering with neuromuscular function (e.g. aminoglycosides)
Exercise in Genetic Cardiovascular Conditions

The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM) and long QT syndrome (LQTS).

Ancillary study Aim: To understand how the coronavirus epidemic is impacting psychological health and quality of life in the LIVE population

Yale is the central site for this multicenter study. Patients with HCM and LQTS will be recruited via high-volume HCM and LQTS sites, patient-groups, and websites. Information about exercise participation will be acquired via interview and online instruments at enrollment and every six months for three years. Quality of Life questionnaires will be filled out at enrollment and at the end of the study. Participants will receive a Fitbit (pedometer) and will wear it initially for two weeks and then one week every three months. The Fitbit is used for assessment of exercise level only. Clinical records will be obtained from treating physicians. Participants will also be asked to call the central site if they experience syncope, appropriate ICD (implantable cardioverter defibrillator) shock, or resuscitated arrest. Information regarding the patient's activity at the time of event will then be obtained by phone interview. Follow-up clinical records will be obtained as indicated to corroborate endpoints.

The Ancillary study is optional. This will include all of the baseline questionnaires,as well as selected questions from the Epi-Pandemic Impacts Inventory.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome

Exclusion Criteria:

* Individuals with Hypertrophic Cardiomyopathy with systolic or diastolic heart failure which precludes vigorous exercise will not be enrolled (NYHA III/IV)
A Study of LY3437943 in Participants With Impaired and Normal Liver Function

The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.


Eligibility Criteria:
Inclusion Criteria:

All Participants:

* Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive
* Healthy or various degrees of hepatic impairment depending on the study group

Exclusion Criteria:

Participants with hepatic impairment:

* Have or are anticipating an organ transplant within the next 6 months
* Requires needle evacuation of ascites fluid more than 2 times per month
* Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\^2 cycle 1, 500 mg/m\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is \>6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points.

* BO21004 (Stage 1a) \[NCT01010061\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported separately.
* BO21004 (Stage 1b) \[NCT01998880\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.
* BO21004 (Stage 2) includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported here.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>/=18 years
* Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
* Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
* Total Cumulative Illness Rating Scale (CIRS) \> 6 and/or creatinine clearance \< 70 ml/min.

Exclusion Criteria:

* Prior CLL therapy
* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
* History of other malignancy unless the malignancy has been in remission without treatment for \>/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone
* Positive hepatitis serology (HBV, HCV) or positive HIV or Human T-Cell Leukemia Virus (HTLV) testing
* Patients with active infection requiring systemic treatment.
Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.


Eligibility Criteria:
Inclusion Criteria:

* Suspected hypothyroidism subject
* Willing to comply with the trial protocol
* Signed informed consent document

Exclusion Criteria:

* Menstrual period, bleeding hemorrhoids, hematuria
* Drinking or taking aspirin within 48 hours
* Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
* Subjects who are unwilling or unable to complete the trial
* Subjects who do not sign informed consent form
Evaluation of Exercise Capacity and Activity Role Adequacy in Patients With Adult Bronchial Asthma

The aim of this study was to evaluate exercise capacity and activity role adequacy in patients with adult bronchial asthma.

Asthma is a chronic inflammatory disease characterized by increased airway sensitivity to various stimuli and reversible airway obstruction. Asthma is a disease with high morbidity and mortality despite all advances in pathogenesis, diagnosis and treatment in the world. It is estimated that there are approximately 300 million asthmatic patients in the world. In our country, approximately one out of every 12-13 adults and one in 7-8 children have asthma. Clinical symptoms of asthma include shortness of breath, wheezing, coughing. Increased symptoms in asthmatic patients lead to impaired respiratory function. In chronic respiratory problems, participants restrict their activity to avoid shortness of breath. As a result, physical fitness levels are reduced, shortness of breath occurs at earlier workloads, and participants do less activity. In chronic disorders, managing the disease alone may not be enough to optimize normal functioning in daily life. In literature, it is seen that daily life activities, quality of life, school performance and work performance are affected in asthmatic patients. it is thought to be useful in determining the course of treatment to be given to the patient in the course of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with bronchial asthma by a chest physician
* Being between the ages of 18-65
* Being in a stable period
* Work in the last 12 months

Exclusion Criteria:

* Severe chronic disease other than bronchial asthma (cancer, chronic obstructive pulmonary disease, chronic heart failure, neurological disease, etc.).
* Any physical disability that prevents walking
* Unable to comply with tests
* lack of reading, speaking and writing in Turkish
Effectiveness of Extended Telephone Monitoring

The purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry
* qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP);
* willingness to participate in research and be randomized;
* 4th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963);
* able to provide the names of several informants who will know his/her whereabouts during the follow-up period

Exclusion Criteria:

* acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication);
* IV heroin use during the past year;
* anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.
Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake

The investigators hypothesize that different types of starch vary in their effects on appetite, blood sugar and food intake. In this study, subjects consumed five soups containing 50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added starch at one week intervals. The investigators measured food intake at 120 minutes, appetite and blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males with a BMI of 20-24.9 kg/m2

Exclusion Criteria:

* Females
* Smokers
* Breakfast skippers
* Individuals with diabetes or other metabolic diseases
A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)

This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin 30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their background therapy with an SSRI. Participants will be allocated to one of two strata. Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2 visit. Participants in both strata will receive the study drug in addition to their background therapy with an SSRI until Week 16.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* On a stable dose of SSRI for at least 8 weeks prior to screening an between screening and Day 1
* An insufficient response to current treatment with an SSRI given at an adequate dose for at least 12 weeks prior to Day 1
* Females who are not postmenopausal or surgically sterile and who have (or may have) male sexual partners must agree to use two adequate methods of contraception as defined by protocol from the start of screening until 90 days after the last dose of study drug

Exclusion Criteria:

* Primary OCD symptom of hoarding
* More than two unsatisfactory trials within the last 2 years with different serotonin reuptake inhibitors (not including the current treatment with an SSRI) given in an adequate dose for at least 12 weeks
* Failure of more than three augmentation therapies within the last 2 years
* Undergoing acute behavioral therapy or having acute behavioral therapy that was completed less than 4 weeks prior to Day 1
* Any primary DSM-IV-TR Axis I disorder other than OCD
* Current or prior history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, or Gilles de la Tourette syndrome if symptoms have persisted into adulthood
* Any eating disorder within the last 6 months
* History of DSM-IV-TR-defined substance dependence and/or substance abuse in the last 6 months, with the exception of nicotine
* Previous treatment with bitopertin or another Glycine transporter 1 inhibitor
* Positive urine drug screening for cannabis, amphetamines (including 3,4-methylenedioxymethamphetamine \[MDMA\]/ecstasy), cocaine, barbiturate, and/or opiates
* Prior or current general medical condition that may impair cognition or other neuropsychiatric functioning
* Body mass index less than (\<) 18.5 kilogram per square meter (kg/m\^2) or greater than (\>) 40 kg/m\^2
* Pregnant or lactating women
Dengvaxia US Pregnancy Registry

The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy

Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

Eligibility Criteria:
The eligible population will include pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry.

Reports of Dengvaxia pregnancy exposure must contain the following information to be included in the registry:

* Sufficient evidence to confirm the case qualifies as "exposed during pregnancy";
* Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Real World Pharmacokinetics of Immune Checkpoint Inhibitors

Rationale: Real-world pharmacokinetic data from cancer patients treated with immune checkpoint inhibitors (ICIs) are sparse. Moreover, pharmacokinetic parameters may be associated with response to ICI treatment and may act as a predictive or early response biomarker.

Objective: To describe the real-world pharmacokinetics of ICIs in patients eligible for ICI treatment or already treated with ICIs.

Study design: A low-interventional cross-sectional pharmacokinetic study. Study population: Patients treated with ICIs. Intervention: A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived.

Main study parameters: Real- world pharmacokinetic parameters of ICIs: clearance, volume of distribution, serum exposure (serum concentration - time curve).


Eligibility Criteria:
Inclusion Criteria:

* Treatment with immune checkpoint inhibitors (atezolizumab (Tecentriq®), avelumab (Bavencio®), cemiplimab (Libtayo®), durvalumab (Imfinzi®), ipilimumab (Yervoy®), nivolumab (Opdivo®) and pembrolizumab (Keytruda®))
* Willingness and ability to provide written informed consent
* Age 18 years or older

Exclusion Criteria: n/a (real-world)
Progressive Collective-exercise Program on the Knee Osteoarthritis

The investigators hypothesized that an eight-week collective group exercise program would improve pain, quality of life and functional capacity in patients with knee osteoarthritis (KOA) compared with those receiving no exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic and moderate to severe medical diagnostic of KOA.
* Subjects with normal cognitive functions and no restriction to perform physical activities were recruited from the hospital's KOA database and eligible to participate if they had presented: Lequesne questionnaire criteria (5 - 13.5), knee pain score between 3 and 7 (on a 0 -10 Visual Analogue Scale), stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and no regular physical exercise or use of canes in the months prior to the study.

Exclusion Criteria:

* Symptomatic heart disease; symptomatic disease of the lower limbs (other than KOA); symptomatic lung disease; severe systemic disease; severe psychiatric illness; regular physical exercise (three or more times per week for at least 3 months); drug injection in the knee in the previous 3 months; physiotherapy on the lower limbs in the previous 3 months and absence in two consecutive training sessions or three nonconsecutive sessions
Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With CHD

Most children with congenital heart disease (CHD) are expected to survive until adulthood. In addition to physical limitations, the growing adolescents with CHD are also challenged at the psychosocial domains. Previous studies have investigated the frailty of elderly, but the research on the intervention to the frailty of adolescents with CHD has been limited. The aims of this study will apply the Walking Instruction based on Self-Efficacy (WISE) program to examine the long-term effects of improving frailty state and quality of life for adolescents with CHD.

This proposal will conduct a three-year series of studies. In the first year, a cross-sectional survey will be used to evaluate the applicability of the Fried frailty index to adolescents with CHD, and to examine the correlation between frailty index and quality of life in adolescent patients. In the second year, investigators will conduct individual in-depth interviews with selected pre-frailty/frailty adolescent participants and their main caregivers to gain insights into their views, connotations and support needs for frailty, which will serve as the basis for the design of the next interventional study. In the third year, the WISE program will be developed to provide 12-week walking self-efficacy improvement education strategies and exercise bracelets with heart rate monitoring. The recruited pre-frailty/frailty adolescent participants will be randomly assigned to experimental and control groups respectively in the pretest-posttest control group design. The changes in frailty state and quality of life for the two groups will be evaluated at 6, 12 and 24 weeks. The results of this study can provide frailty evaluation indicators for adolescents with CHD, timely detect the pre-frailty stage, and provide an important reference for the prevention of frailty intervention for adolescents with CHD as early as possible.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 12-18 years old.
2. Congenital heart disease diagnosed by a doctor before the age of 2.
3. The American New York Heart Association (NYHA) classifies the cardiac function as I-III grades.
4. Adolescents and their parents or guardians can communicate in Mandarin and Taiwanese and have normal cognitive abilities.
5. Those who are willing to cooperate with the research and complete the consent form.

Exclusion Criteria:

1. Received a heart transplant within one year.
2. Have undergone open-heart surgery within six months.
3. The New York Heart Association (NYHA) classifies the cardiac function as class IV.
4. Combined with other congenital diseases.
The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance

Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.

This will be an open-label, prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes, comparing to an existing historical dataset of patient reported outcomes with bilateral ReSTOR 3.0 implants.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with the PanOptix or Panoptix Toric lenses bilaterally within 6 months of the survey administration. Patients may have the toric version of this lens in neither eye, one eye, or both eyes.
* Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
* Patients whose spherical equivalent outcome is within 0.5D of target and whose magnitude of manifest postoperative cylinder is less than or equal to 0.75 diopters.

Exclusion Criteria:

* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered intraocular lens, cystoid macular edema, etc.)
* Patients with greater than grade 1 posterior capsule opacity.
* Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -
Evaluation of the Success Rate of Immediately Loaded Implants

Evaluation of the success rate of immediately loaded implants based on:

* condition of the gingiva
* stability of the implants
* evaluation of the RXs
* questionnaires


Eligibility Criteria:
Inclusion Criteria:

* Patients with immediately loaded implants
Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases

This is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates. Thoracoscopic surgery involves insufflation of carbon dioxide into the thoracic cavity and may therefore cause hypercapnia and acidosis.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with diagnosis of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia

  -\>1.6 Kg
* Conventional ventilation (no high frequency ventilation or iNO) for at least 24 hours.
* FiO2 \<0.4
* No requirement for inotropes for at least 24 hours

Exclusion Criteria:

* Late diagnosis (after 1 month of age)
* Major congenital heart defects or pulmonary hypertension
* Bilateral grade IV intraventricular haemorrhage
* Previous ECMO
* FiO2 ≥ 0.4
A Study to Evaluate the Efficacy and Safety of AD-203

This is a multicenter, active-controlled , randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of AD-203 to demonstrate the non-inferiority of AD-203 compared with Mucosta tab. in patients with acute or chronic gastritis


Eligibility Criteria:
Inclusion Criteria:

* Age is over 20 years old, under 75 years old, men or women
* Patients diagnosed with acute or chronic gastritis by gastroscopy

Exclusion Criteria:

* Patients who is impossible to receive gastroscopy
* Patients taking other investigational drugs or participating in other clinical studies in 3 months prior to screening visit