cyrilzakka/clinical-trials huggingface dataset:
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA \< lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* Infection with HCV genotype 1
* HCV RNA \> LLOQ at screening
* Participation in a prior Gilead-sponsored study
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
* Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
* Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)
* Hepatocellular carcinoma (HCC)
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Accu-Chek® CONNECT at School (CATS) Pediatric Study

This interventional, 6-month post-marketing study is designed to evaluate the change in diabetes-related distress among parents/caregivers of school-age children and adolescents with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy. Investigational sites will be assigned using cluster randomization, with approximately 10 to 20 children at each site. In order to maintain a true control group for comparison, the investigational sites will be randomly assigned to the Accu-Chek® CONNECT Diabetes Management System (DMS) or usual care/continued use of current DMS devices.


Eligibility Criteria:
Inclusion Criteria:

* Children or adolescents, aged 6 to 18 years
* Diagnosis of T1D for at least 3 months
* Currently managed with insulin Multiple Daily Injection (MDI) therapy
* Attending full-day school schedule in Grade K through 12
* Able to provide SMBG data minimum of one month prior to study start
* Currently using a compatible Smartphone with ability to download the Accu-Chek® CONNECT System App accordingly OR ability to utilize Smartphone and Accu-Chek® CONNECT System App as provided for use in study
* Adolescents (18 years) with diabetes provide written informed consent
* Children 7 to 17 years to provide age-appropriate child assent
* Parent/caregiver currently using a compatible Smartphone with ability to receive Short Message Service/Multimedia Messaging Service (SMS/MMS) messages
* Able to read/write in English and comply with study procedures, including provision of self-monitoring blood glucose (SMBG) data at least 1 month prior to the study

Exclusion Criteria:

* Current or planned use of continuous subcutaneous insulin infusions during the study period
* Use of continuous glucose monitoring or a remote data-sharing system/device (i.e. NightScout, DexCom Share, Medtronic Connect) during the study
* Pregnancy
* Clinically significant medical condition(s) such as anemia, major organ system disease, infection, psychosis, or cognitive impairment
* Requirement for chronic steroids, immunomodulatory medication, or chemotherapy in adrenal suppressive doses
* Visual impairment preventing use of the Accu-Chek® CONNECT system
* Parent/caregiver is an investigator, general practitioner, practice staff, pharmacist, research assistant, or other staff or relative of those directly involved in the study
Effects of Massage Between Sets of an Intense Isokinetic Exercise- Protocol of Knee Extensors in Tae Kwon Do Athletes

26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (MG) a sport massage was applied between the sets while in the control group (NMG) the break was passive.

Objective: Τo investigate the effects of massage in athletic performance when applied during intervals of an intense isokinetic exercise protocol for knee extensor muscles.

Design: Randomized Controlled Trial. Participants: 26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (MG) a sport massage was applied between the sets while in the control group (CG) the break was passive.

Main Outcome Measures: knee flexion and extension ROM, thigh circumference, and creatine kinase (CK) levels in blood plasma were measured before and after each test while L-DOMS was measured 24, 48, 72 and 96 hours after the exercise.

Eligibility Criteria:
Inclusion Criteria:

* Professional athletes
* Age range between 18-25.

Exclusion Criteria:

* Conduction of any strengthening exercises on the day before the tests
* Musculoskeletal injury during the last six months
* Background of knee trauma and/or surgery
Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor

The purpose of this study is to conduct a comparative study through clinical trials to verify the safety and efficacy of the products in the experimental group for clinical use.

The product of this clinical validation is the fixed button plate system, which is used for the reconstruction of the coracoclavicular ligament in the treatment of recurrent shoulder dislocation. The clinical trial was conducted to verify the rationality of its structural design, the convenience of its operation, and the effectiveness and safety of its clinical use. This trial was conducted in a parallel controlled trial design, the patients were divided into test and control groups to evaluate the safety and efficacy of the product.

Eligibility Criteria:
Inclusion Criteria:

1. a glenoid defect ≥10%
2. contact sport athletes with a glenoid defect \< 10%
3. failure after Bankart repair.

Exclusion Criteria:

1. epilepsy
2. multidirectional shoulder instability
3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
4. Follow-up was less than 2 years or incomplete follow-up data.
Telehealth Multi-Component Optional Model (MOM) Study

The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 16-35 weeks gestation
* Age 18-44 years
* Ability to speak English, Spanish, or Marshallese
* Participants may have either a vaginal birth or cesarean section birth

Exclusion Criteria:

* Type 1 diabetes on an insulin pump followed closely by endocrinology
* Uncontrolled Type 2 diabetes
* End stage renal disease followed closely by nephrology
* ICU admission at any point during pregnancy or delivery hospitalization
* Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
* Incarceration
* Mental disability limiting decision-making capacity
* Uncontrolled chronic hypertension
* HELLP syndrome during pregnancy
* Sickle cell disease
* Maternal heart condition or heart disease
* Opioid use disorder
* Lupus
* Thrombophilia or blood clots
* Need for blood transfusion during delivery hospitalization
* Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum
Effects of Mechanical, Chemical, and Combination Methods on Halitosis

Goal:

The goal of this clinical trial is to evaluate the effectiveness of different oral hygiene methods (tooth brushing, tongue cleaning, and mouthwash use) in managing halitosis (bad breath) in adults. The main questions it aims to answer are:

Do oral hygiene methods (tongue cleaning, chlorhexidine mouthwash, and coconut oil mouthwash) reduce the levels of volatile sulfur compounds (VSCs) in participants' breath?

Do these methods improve self-reported and clinically assessed halitosis?

Study Design:

Researchers will compare three intervention groups:

Group I: Tongue cleaning. Group II: Chlorhexidine mouthwash. Group III: Coconut oil mouthwash.

After one week, Groups II and III will add tongue cleaning, and in the third week, Groups I and III will use chlorhexidine mouthwash to ensure equitable benefits.

Participants will:

Follow their assigned oral hygiene regimen daily for 2 weeks. Receive the halitosis assessments at baseline, 1 week, and 2 weeks post-intervention, including organoleptic testing and volatile sulfur compounds level measurements using the OralChroma device.

Complete self-reported assessments of halitosis using a visual analog scale (VAS).


Eligibility Criteria:
Inclusion Criteria:

* Age: Participants must be 18 years or older.
* Diagnosis of Halitosis:

  * Clinically diagnosed halitosis with an Organoleptic Test (OT) score ≥ 2, AND
  * Volatile sulfur compound (VSC) levels exceeding:

Hydrogen sulfide (H2S) \> 1.5 ng/10 ml, OR Methyl mercaptan (CH3SH) \> 0.5 ng/10 ml.

* Study Population: Buddhist monks and nuns from selected temples in Hue City, Vietnam, to control for dietary and lifestyle factors.
* Willingness to Participate: Participants must provide informed consent and agree to follow the study protocol.

Exclusion Criteria:

* Systemic Diseases: Presence of systemic conditions such as diabetes, gastrointestinal disorders, respiratory disorders, or cancer that could contribute to halitosis.
* Nonoral Causes of Halitosis:Halitosis suspected or confirmed to be caused by gastrointestinal or respiratory diseases.
* Medication Use: Use of antibiotics or other medications within 1 month prior to or during the study period.
* Dental Conditions:

  * Presence of dental prostheses or orthodontic appliances.
  * Untreated open caries lesions or deep periodontal pockets (\> 6 mm).
* Allergies: Known allergies to any of the study interventions (e.g., chlorhexidine or coconut oil).
* Lifestyle Factors: Smoking or betel nut chewing habits.
* Inability to Comply: Inability or unwillingness to follow the study protocol or attend follow-up visits.
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients with Type 2 Diabetes Mellitus

This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Males or females
* 18-65 years old, inclusive
* BMI 27.0-40.0, inclusive
* Stable body weight for 2 months

Exclusion Criteria:

* Significant medical history
* Uncontrolled hypertension
* History of malignancy
Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain

Neck pain is a common medical condition among office workers all over the world. The purpose of this study was to see if physical exercise, such as basic body awareness, neck-specific training exercises, and ergonomic modifications, could help reduce pain, disability, and job stress while also improving quality of life among office workers. Participants will be assigned at random to either an experimental (exercise therapy and ergonomic modification) or a control group (ergonomic modification).


Eligibility Criteria:
Inclusion Criteria:

* Age 25-60 years
* Greater than 3 months of chronic NSNP.
* Office workers and computer users
* The ability to continue working

Exclusion Criteria:

* A history of severe injury
* Previous physical therapy treatments
* Joint instability
* Frequent migraines
* Spasmodic torticollis
* Inflammatory rheumatic diseases
* Peripheral nerve entrapment
* Severe psychiatric illness
* Pregnancy
* Other conditions that prevent physical loading.
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer

A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

Part A,B,C and D:

* Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Part A:

* Progression on at least 2 prior approved systemic therapies for metastatic prostate cancer (at least one must be a second-generation androgen inhibitor, e.g., abiraterone, enzalutamide, darolutamide, apalutamide).
* Progressive mCRPC

Part B:

* Participants must have received at least one but no more than three prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone).
* Participants must have received no more than two prior chemotherapy regimens.
* Progressive mCRPC

Part C \& D:

• Metastatic castration resistant or sensitive prostate cancer with radiographic evidence of metastatic disease

Exclusion Criteria:

Part A and B:

* Known symptomatic brain metastases requiring steroids (above physiologic replacement doses).
* Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery.
* Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow.
* Receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose
* Systemic anti-cancer therapy within 2 weeks of first dose of study drug (except agents to maintain castrate status). For bicalutamide, mitomycin C, or nitrosoureas the exclusion period must be 6 weeks and for abiraterone 4 weeks.

Part C and D

• Prior treatment with a second generation NHA
Incidence of Caries in Smoking and Smokeless Tobacco

The following observational study evaluates incidence of caries in smoking and smokeless tobacco based on habit history by clinical examination and DMFT index.

Dental caries is an irreversible microbial disease of the calcified tissues of the teeth, characterized by demineralization of the inorganic portion and destruction of the organic substance of the tooth, which often leads to cavitation. It is a complex and dynamic process where a multitude of factors influence and initiate the progression of disease. There are practically no geographic areas in the world whose inhabitants do not exhibit some evidence of dental caries. It affects persons of both genders in all races, all socioeconomic strata and every age group. Likewise, there is strong evidence that tobacco use has numerous negative effects on oral health, for example staining of teeth, dental restoration, development of oral diseases. A biologically reasonable explanation for an association between chewing tobacco use and dental caries may be the presence of higher levels of fermentable sugars in chewing tobacco products which can stimulate the growth of carcinogenic bacteria. The decreased buffering effect possible lower pH of smokers saliva and higher number of lactobacilli and streptococcus mutans group may indicate an increased susceptibility to caries in smokers. On the other hand, there are researches which conclude that presence of extrinsic tobacco stains appear to provide a protective effect from caries.

Eligibility Criteria:
INCLUSION CRITERIA:

* Patients who are willing for the study.
* A positive history of dental caries in smokers and smokeless tobacco.
* Patients with caries not under any treatment of the same.

EXCLUSION CRITERIA:

* Unwilling patients who do not want to be a part of the study.
* Patient with fluorosis.
In the Real World Study, the Efficacy and Adverse Reactions of Ticagrelor on Ischemic Cerebrovascular Disease

This is a forward-looking, open, one-arm, and real clinical trial world. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study is to establish a population pharmacokinetic model of ticagrelor , explore the correlation between its blood concentration and the events of ischemia and the adverse effects of hemorrhage, and evaluate the effectiveness and safety of ticagrelor in the treatment of ischemic cerebrovascular disease.

Ischemic stroke and transient ischemic attack are the most common types of ischemic cerebrovascular disease. Patients will suffer from physiological function damage, even mental symptoms, social function and other obstacles, seriously affecting the quality of life, and bringing heavy burden to families and society.

Ticagelor is a new P2Y12 receptor antagonist. Compared with clopidogrel, ticagelor has stronger and more lasting platelet inhibition, and can reduce the recurrence of ischemic events in patients with acute coronary syndrome .

Therefore, at least 50 patients with ischemic cerebrovascular disease using ticagelor will be included. Before and after treatment, the laboratory examination data, NIHSS, mRS, combined medication and adverse events, and ischemic events of the patients will be collected. The population pharmacokinetics model of Ticagelor was established to evaluate its effectiveness and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male aged ≥ 18 years.
2. Clinically diagnosed as ischemic cerebrovascular disease.
3. Take ticagelor for antiplatelet therapy.
4. Provision of informed consent.

Exclusion Criteria:

1. Head CT or MRI suggests the presence of intracranial hemorrhagic disease.
2. People with tumors and other serious systemic diseases.
3. Allergy to ticagelor.
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.

First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.
* Subjects initiating raltegravir plus another fully active antiretroviral drug.

Exclusion Criteria:

* Pregnancy, or fertile women willing to be pregnant.
* Active substance abuse or major psychiatric disease.
Two Year Follow up of Cadence Total Ankle Replacement

Over the last decades, total ankle replacement (TAR) emerged as a reliable treatment option in end-stage ankle osteoarthritis (OA) while preserving motion and physiological load. The Cadence™ is a fourth-generation, two-component, fixed-bearing implant with minimal tibial and talar resection. It has been in clinical use since July 2016, the purpose of this study was to compare the clinical outcome and radiological outcomes of total ankle arthroplasty with use of the Cadence™ prosthesis at St. Michael's Hospital.

Over the last decades, total ankle replacement (TAR) emerged as a reliable treatment option in end-stage ankle osteoarthritis (OA) while preserving motion and physiological load. The Cadence™ is a fourth-generation, two-component, fixed-bearing implant with minimal tibial and talar resection. It has been in clinical use since July 2016, the purpose of this study was to compare the clinical outcome and radiological outcomes of total ankle arthroplasty with use of the Cadence™ prosthesis at St. Michael's Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Ankle arthritis treated with Cadence Total Ankle Replacement system

Exclusion Criteria:

* Under 18 years of age
The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin

The aim of this project is to assess the influence of exercise on pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of subcutaneously (sc) administered unfractionated heparin (UFH). It is hypothesized that exercise will increase the systemic exposure (PK) and therefore the clinical effects (PD) of the sc administered UFH.

To assess this, healthy male volunteers will be included in a controlled, randomized, crossover study, where they, on four separate days, will have UFH injected sc in the thigh, followed by different exercise interventions (one per experimental day). Blood sampling, with the aim of assessing PK and PD will be performed during the following hours.


Eligibility Criteria:
Inclusion Criteria:

* Body weight 50 kg or more
* Body Mass Index 18.5-25 kg/m2
* Acceptance of not drinking alcohol for 24 hours before to 24 hours after dosing of study drug
* Acceptance of not performing physical activity for 24 hours before to 24 hours after dosing of study drug
* Signed informed consent form

Exclusion Criteria:

* History or sign of bleeding disorders
* History or sign of kidney disease
* History or sign of liver disease
* Average systolic blood pressure \<100 mmHg or \>140 mmHg and/or average diastolic blood pressure \<60 mmHg or \>90 mmHg (average of three measurements performed at screening).
* Daily pharmaceutical treatment
* Contraindication to increased levels of physical activity (10)
* Smoking or other regular use of any form of nicotine products during the study period and the previous 3 months.
* Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
* Previous treatment with heparins
* Low levels of anti-thrombin (P-antitrombin(enz.) \<0,80 kIU/L)