cyrilzakka/clinical-trials huggingface dataset:
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with idiopathic PD.
2. At least 30 years old at the time of PD diagnosis.
3. Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:

   * Requiring a total daily IR LD dose of at least 400 mg
   * Having a minimum dosing frequency of four times per day.
4. Able to differentiate "on" state from "off" state.
5. Have predictable "off" periods.
6. Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
7. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.

Exclusion Criteria:

1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
2. Nonresponsive to LD therapy.
3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
4. Received within 4 weeks or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
5. Allergic to Yellow Dye #5 (tartrazine).
6. History of or currently active psychosis.
7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
8. Active or history of narrow-angle glaucoma.
9. A history of malignant melanoma or a suspicious undiagnosed skin lesion.
10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
11. Received any investigational medications during the 4 weeks prior to Screening.
12. Unable to swallow large pills (e.g., large vitamin pills).
13. Pregnant or breastfeeding.
14. Subjects who are unable to complete a symptom diary.
Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
* Planning to initiate chemotherapy under the guidance of Moffitt
* Able to speak and read English or Spanish
* Able to provide informed consent

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
* Undergoing concurrent treatment for a second primary GI cancer
* ECOG status of 2 or greater
* Receipt of chemotherapy in the past 6 months for recurrent pancreatic cancer
* Use of parenteral or enteral nutrition
* Presence of malignant ascites
* The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.
Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine

Post-marketing, retrospective, observational survey study. Users (menstruating women only) of Nerivio who have used Nerivio at least 4 times between October 2019 and December 2020 will be contacted by email and/or through an app notification and will be asked to complete a 5-minute online anonymous survey assessing satisfaction, effectiveness, and safety. Eligible users will sign an informed consent form (the consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page) and complete a survey asking about their satisfaction with Nerivio and the effectiveness and safety of the device for acute treatment of menstrual migraine. During the survey, participants will be screened to verify that they have menstrual migraine (self-reported) and have used Nerivio to treat menstrual migraines.

This study aims to evaluate the safety and efficacy of Nerivio for the acute treatment of menstrual migraine (pure menstrual migraine or menstrually-related migraine).

Up to 500 US-based adults aged 18-55 years old who have been prescribed the Nerivio device and have used it at least 4 times between October 2019 and December 2020.

Informed consent must be obtained from the participant before any protocol-related activities are performed. The consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page.

Users of Nerivio whose details are in the sponsor's database will be contacted by email (provided by the patient during the sign-up process in the Nerivio app required to use the device) and/or through an app notification and will be asked to complete a 5-minute online survey assessing satisfaction, effectiveness, and safety. Participants will sign an informed consent form which will appear as the first page of the survey using open-ended questions, multiple choice questions and Likert scales. Participants will be directed to provide honest opinions regarding the device use for menstrual migraine. No additional information will be collected, and no medical records will be used in this investigation.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-55 years
2. Participants have used Nerivio at least 4 times
3. Participants experience menstrual migraines (pure menstrual migraine or menstrually-related migraine; self-reported)
4. Participants have used Nerivio to treat menstrual migraine

Exclusion Criteria:

1. Non-menstruating women
RATe Control in Atrial Fibrillation

The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and carvedilol on ventricular rate, working capacity and quality of life in patients with chronic atrial fibrillation.

This is a randomised, single blinded, cross-over study comparing the efficacy of metoprolol 100 mg o.d., verapamil 240 mg o.d., diltiazem 360 mg o.d. and carvedilol 25 mg o.d. in reducing ventricular rate in atrial fibrillation. A total of 60 patients will be included, with a minimum of 20 women.Patients will receive each of the drug regimens in a random sequence. Each regimen will be administered for 3 weeks, ensuring that steady-state drug concentration will be attained and to provide an adequate washout of the previous treatment. Following each regimen, exercise ECG and Holter registration will be performed and patients will undergo laboratory evaluation and complete QoL-forms. They will then be started on the next randomly assigned treatment regimen, until the entire sequence of treatment schedules is completed.

Eligibility Criteria:
Inclusion Criteria:

* Persistent or permanent atrial fibrillation with ventricular rate \> 80/min at rest and/or \> 100/min average at daytime.
* Male or female, age \> 18.

Exclusion Criteria:

* Hypersensitivity or contraindication to metoprolol, verapamil, diltiazem or carvedilol.
* Coronary heart disease or heart failure
* Systolic blood pressure \< 100 mmHg
* AV-conduction disturbance
* Severe hepatic or renal dysfunction
* Thyrotoxicosis
* Ongoing treatment with Digitalis
* Pregnancy or lactation
Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%

Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.

The presence of micropapillary component in adenocarcinoma is a predictor of poor prognosis, and has been reported to be to be chemosensitive to platinum-based chemotherapy. Seeking a more appropriate treatment for these patients, we perform this randomized phase II clinical trial. About 460 stage I lung adenocarcinoma patients with micropapillary component ≥ 20% will be included and divided into two group. Patients in the control group will only undergo complete R0 resection of the lesion, no further therapy will be used. While patients in the experimental group are going to receive platinum-based chemotherapy (comprising cisplatin and pemetrexed disodium)about 1 month after therapeutic surgery. Treatment continues every 3 weeks for 4 courses. Clinic and telephone follow up will be conducted for survival data monitoring.

DFS(disease free survival rate) and OS(overall survival rate) curves will be calculated using the Kaplan-Meier, life-table method. Comparison of the survival curve for the two groups will be performed using the log-rank test.

Eligibility Criteria:
Inclusion Criteria:

* Completely resected Stage I NSCLC as defined by the International Staging System
* Pathologically diagnosed Stage I micropapillary predominant lung adenocarcinoma
* Patients must be randomized within 4 weeks from the date of surgery
* No prior chemotherapy or radiation for non-small cell lung cancer
* Performance status of 0 or 1
* Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
* Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease free for five years
* Granulocytes \>= 1,800/ul
* Platelets \>= 100,000/ul
* Bilirubin \< 1.5 mg/dl
* SGOT(serum glutamic-oxaloacetic transaminase) (AST) \< 2.0 x ULN(upper limit of normal value)

Exclusion Criteria:

* Do not meet the inclusion criteria
* There is evidence of distant metastases
* Suffered from other malignancies in five years
* Within the past January subjects received other drug trials
* Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
* Severe lung or heart disease, a history
* Refuses or is unable to sign informed consent to participate in trials
* The abuse of drugs or alcohol addicts.
* Patients with difficult to control bacterial, viral, fungal infections
* Having a personality or mental disorders, without civil capacity or restricted civil capacity.
* Being pregnant or lactating women.
Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound

The primary aim of this study is to perform an ultrasonographic swallowing assessment in Parkinson's patients and healthy volunteers and compare the findings with those from clinical swallowing evaluations. The secondary aim is to examine the relationship between dysphagia and functional status.

Thirty patients aged 40-80 years, diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stage 1-3), and thirty healthy volunteers who either applied to the Physical Therapy and Rehabilitation outpatient clinic or received inpatient rehabilitation at Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital will be included in this study. At the start of the study, sociodemographic data of both patients and volunteers will be recorded. The Mini-Mental Test and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used to evaluate the mental and functional status of the patients diagnosed with Parkinson's disease. After the clinical dysphagia evaluation, the EAT-10 questionnaire will be administered to the participants. Following this, an ultrasonographic swallowing assessment will be performed on the participants. The ultrasonographic measurements will include tongue thickness (cm), resting distance between the mandible and hyoid (cm), shortest distance between the mandible and hyoid (cm), hyoid displacement (cm), hyoid displacement percentage, tongue thickness (cm) (with 5ml of water), resting distance between the mandible and hyoid (cm) (with 5ml of water), shortest distance between the mandible and hyoid (cm) (with 5ml of water), hyoid displacement (cm) (with 5ml of water), and hyoid displacement percentage (%) (with 5ml of water).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease by a neurologist.
* Being in stages 1-3 according to the Modified Hoehn-Yahr Staging Scale.
* Scoring at least 24 on the Mini-Mental State Examination (MMSE).
* Not having received any therapy or treatment affecting swallowing, other than routine medication for Parkinson's disease.

Exclusion Criteria:

* Presence of head or neck cancer that could cause dysphagia.
* History of radiotherapy or surgery in the head and neck region.
* Diagnosis of vascular parkinsonism or stroke.
* Presence of cardiopulmonary disease that could affect swallowing or breathing.
* Having received voice or swallowing therapy in the last 6 months.
* Presence of a diagnosed psychiatric disorder.
Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity

Memantine is a drug for the management of Alzheimer's Disease (AD) due to its promising neuroprotective properties. We hypothesize that Memantine possesses a beneficial role against chemotherapy-induced neuronal damages.


Eligibility Criteria:
Inclusion Criteria:

histologically confirmed diagnosis of stage III colorectal cancer performance status \< 2 according to Eastern Cooperative Oncology Group (ECOG) score adequate renal function (glomerular filtration rate ≥ 90)

Exclusion Criteria:

preexisting neuropathic or brain disorders, a previous use of chemotherapeutic agents including oxaliplatin use of drugs reported to have neuroprotective role
Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

This clinical trial aims to assess the efficacy of topical Piper crocatum in treating Anogenital warts. It aims to answer

* the clinical efficacy of treating anogenital warts
* the expression of Foxp3+ regulatory T (Treg), TGF/Tumor Growth Factor -β1, and IFN/interferon -γ of anogenital wart lesion Participants will be allocated into two topical treatments, intervention and active comparator Trichloroacetic Acid (TCA) 90%. The researchers assume that intervention is superior compared to TCA 90%

Study Design :

A randomized controlled trial

Population:

Diagnosed with Condyloma Acuminata (International Classification of Disease 10 code A.63.0)

Intervention period :

8 weeks of daily topical intervention with follow-up at week 12

Detailed formulation

1. Extraction of Piper crocatum with ethanol assisted in a microwave-assisted extraction (MAE)
2. The dissolution and active substances are separated by evaporation using a rotary evaporator to obtain the extract in the form of a thick solution
3. freeze-drying is performed to obtain a stable thick extract
4. preparation of ointment by adding formulation of ethanol extract of red betel leaves with 50 mg of white vaseline to achieve 30% concentration

Settings:

Outpatient care at the designated hospital

Participants:

Consecutive recruitment

Sample Size Estimation:

Following the formula of two different means, with the indicator, as follows:

1. Type 1 error 5%
2. Power of Study 80%
3. Assuming the effect size of cohen d (in reducing the size of warts) is 0.5
4. equal allocation between two arms total sample: 100 participants

Proposed analysis:

Intention to treat (ITT) with sensitivity and subgroup analysis

Eligibility Criteria:
Inclusion Criteria:

1. Men and women diagnosed with external anogenital warts
2. Clinical lesions of Anogenital Wart at least 3 lesions with a size of 1-5 cm
3. In patients with HIV, Cluster of Differentiation 4 (CD4)cell count \>350 cells/mm and have been taking antiretroviral (ARV) drugs regularly for 3 months,

Exclusion Criteria:

1. Pregnant or lactating women
2. Lesions located in the external urethral orifice and vagina
3. Using systemic immunomodulators/immunosuppressants

The protocol treatment will be discontinued if patients

a. Withdraw their consent based on the patient's demand d. Severe adverse events occurred or allergies to the components of the test product b. After undergoing clinical trials, the patient experienced things that caused him/her to no longer meet the criteria set out in this protocol. c. Subjects do not comply the established study protocol
Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars

This study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.

The aim of this study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace Wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.

PICO:

P: children aged 6-9 years old with high caries risk.

I: Embrace Wetbond.

C: Clinpro seal.

O:

Primary outcome: Retention of sealant; Device of measurement: questionnaire; unit: binary.

Secondary outcome: Retention and development of caries; Device of measurement: Modified simonsen's criteria; Unit: scoring system (0-4) tactile and visual examination.

Eligibility Criteria:
Inclusion Criteria:

* children aged 6-9 years
* children with high caries risk
* cooperative children
* fully erupted first permanent molars

Exclusion Criteria:

* children with hypoplastic teeth
* partially erupted
* uncooperative children
* children with carious molars.
Supine vs Prone Position During Delayed Cord Clamping

This study is conducted to evaluate if the prone position of the newborn on the chest of his mother at birth before delayed cord clamping leads to better hematocrit and hemoglobin at 24-48 hours of life compared to supine position.

At 30 hours of life, laboratory personnel drew a capillary sample from the infant's heel for hemoglobin, hematocrit, and total serum bilirubin at the same time as the newborn metabolic screening sample. There is no added heelstick to routine care, as current standard in our institution requires the bilirubin to be drawn at 30 hours of life.

During universal screening for congenital cardiac defects (30 hours of life), a value of cerebral saturation (CrSO2) is measured using NIRS with INVOS (In Vivo Optical Spectroscopy, INVOS System, Covidien, Dublin, Ireland, Somanetics). Sensors are placed over the forehead and the newborn is in supine position.

Eligibility Criteria:
Inclusion Criteria:

Newborn ≥ 36 weeks gestational age and Born vaginally and Well appearing

Exclusion Criteria:

Out born infant, Infant born by caesarian section, Preterm born less than 36 weeks GA, Infant with intra uterine growth restriction (IUGR: less than 10th percentile) Asphyxiated infant Infant needing immediate resuscitation, Newborn with malformation (gastroschisis, omphalocele, anal atresia, severe head skin injury, congenital cardiac disease Newborn with mother with preeclampsia or gestational hypertension or diabetes on insuline or hemolytic disease or on chemotherapy or on cortisone.
Clinical Trial of TQB3002 in Patients With Advanced Cancers

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
* Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
* Histologically or cytologically diagnosed with advanced cancers
* Subjects with advanced malignancies who have failed standard therapy or lack effective treatment
* Major organs are functioning well；
* Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.

Exclusion Criteria:

* Current concomitant presence of other malignancies within 5 years prior to the first dose；
* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy
* Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose
* Long-term unhealed wounds or fractures
* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose
* Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy
* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder
* Subjects with any severe and/or uncontrolled disease