cyrilzakka/clinical-trials huggingface dataset:
Antimalarial Drug Resistance With Assessment of Transmission Blocking Activity

This is a two-arm, open label Treatment Study comparing the efficacy, safety, tolerability and pharmacokinetics of a three-day course of Dihydroartemisinin-Piperaquine (DP) with or without single-dose primaquine in patients with uncomplicated Plasmodium falciparum malaria. On the last day of DP therapy, volunteers will be randomized to receive either a single 45 mg dose of primaquine (PQ) or DP treatment only (no primaquine).

Volunteers with uncomplicated malaria in Cambodia will be enrolled to current standard of care therapy with DHA-piperaquine to monitor therapeutic efficacy and measure resistance. The cardiac safety of piperaquine will be monitored with electrocardiograms during the treatment period. Resistance to DP and DP-PQ will be assessed by a combination of clinical, pharmacologic, and parasitologic parameters including genomic signatures of selection during careful weekly follow-up visits for 42 days. Volunteers will be randomized on day 3 to either a single 45mg dose of primaquine or no sexual stage therapy to evaluate effects of primaquine on the sexual stages of malaria (gametocytes) and potential transmissibility of infection to Anopheles mosquitoes as compared to those not treated with primaquine.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer with uncomplicated P. falciparum malaria (volunteers with mixed P. falciparum and P. vivax infections may be enrolled), 18-65 years of age
2. Baseline asexual parasite density between 1,000-200,000 parasites/uL
3. Able to provide informed consent
4. Available and agree to follow-up for anticipated study duration including 3 day treatment course at the MTF and weekly follow-up for the 42-day period
5. Authorized by local commander to participate if active duty military

Exclusion Criteria:

1. Allergic reaction or contraindication to DHA, piperaquine or primaquine
2. Significant acute comorbidity requiring urgent medical intervention
3. Signs/symptoms and parasitological confirmation of severe malaria
4. Use of any anti-malarial within the past 14 days.
5. Class I or II G6PD deficiency (defined as severe) as determined at screening
6. Pregnant or lactating female, or female of childbearing age, up to 50 years of age, who does not agree to use an acceptable form of contraception during the study
7. Clinically significant abnormal EKG, including a QTcF interval \> 500 ms at enrollment.
8. Known or suspected concomitant use of QTc prolonging medications.
9. Judged by the investigator to be otherwise unsuitable for study participation
The Effectiveness of AI Molar Mind for Smoking Cessation Through Dental Health Evaluation

Smoking cessation remains a significant public health challenge, with millions of individuals struggling to quit despite available interventions.

Oral health deterioration is a well-documented consequence of smoking, including periodontal disease, tooth discoloration, and oral cancer. Recent advancements in artificial intelligence (AI) have led to the development of AI Molar Mind, a digital tool designed to assess oral health and provide personalized feedback to motivate behavioral change. This study aims to evaluate the efficacy of AI Molar Mind in aiding smoking cessation by leveraging oral health evaluations as a motivational tool.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-65 years
* smoke ≥5 cigarettes per day
* motivated to quit smoking,
* have access to a smartphone or computer

Exclusion Criteria:

* Pregnant women
* individuals with severe psychiatric conditions
* those already using other smoking cessation therapies.
Impact of Time Restricted Feeding on Daily Protein Requirements

The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults.

The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults. Individuals in the TRF pattern will only consume food during a 6-hour eating period and fast for the remaining 18 hours. Individuals in the TRAD pattern will consume isocaloric and isonitrogenous (RDA or 2RDA) diet but consume an all-beef-breakfast. Participants will consume oral stable isotopes to measure muscle protein synthesis (MPS), whole-body muscle protein breakdown (MPB), and whole-body protein balance (WBPB). Appropriate muscle, blood samples, and urine will be collected throughout a 24-hour metabolic trial following a 2-day controlled diet.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women ages 50-75 years.
2. BMI 20-30 kg/m2 inclusive.
3. Capable of providing informed consent.
4. COVID-19 negative and/or asymptomatic

Exclusion Criteria:

1. Subject who does not/will not eat animal protein sources.
2. Body mass index \<20 or \>30.
3. Hemoglobin \<10g/dL at screening.
4. Platelets \<150,000/uL at screening.
5. History of diabetes.
6. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
7. History of gastrointestinal bypass/reduction surgery.
8. History of a chronic inflammatory disease (e.g. what?)
9. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
10. Currently using prescription blood thinning medications.
11. Currently using corticosteroid medications.
12. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
13. Unwilling to avoid using protein or amino-acid supplements during participation.
14. Subjects who are unwilling to fast overnight.
15. Participating in \>200 minutes/week of vigorous exercise and/or \>4 days/week of resistance training.
Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

* Phthalate is an endocrine disrupting chemical, which works as an anti-androgenic agent.
* Phthalate is mainly used as PVC plasticizer and easily found in commonly used products such as electronic device, paint, lubricant, surfactant, medical supplies, spray etc. Especially, PVC blood bag used for blood transfusion have been reported to have high level of phthalate concentration.
* Previous studies reported that urinary concentration of phthalate metabolites and HOMA (Homeostatic model assessment, indicator of insulin resistance) has positive association.
* Previous studies also reported negative associations between urinary phthalate concentration and pulmonary function.
* Exposure to phthalates occurs mainly through oral route. Food wrapping with phthalate containing package material is expected to be one of the major contributor for phthalate exposure.
* In this present trial, the investigators are to examine whether increased phthalate exposure by consuming beverage stored in PVC containing packing materials actually effect insulin resistance, pulmonary function and epigenetic feature.
* For this aim, the investigators will conduct a cross-over trial.


Eligibility Criteria:
Inclusion Criteria:

* Participants who understand aim of this study and who provided informed consent

Exclusion Criteria:

* Who did not provided informed consent
* Person who are undergoing or planning to take a treatment due to liver, nervous system, respiratory system, hematologic, oncologic, psychiatric, cardiovascular(angina pectoris, myocardial infarction, stroke etc), endocrinal(Diabetes mellitus, thyroid disease) disorders.
Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention

The main objective of this pilot study is to investigate the protein / peptide plasma profiles before and after treatment with a direct anti-Xa (activated Factor 10) in patients with non-valvular atrial fibrillation to better understand the mechanisms of action of these molecules and perform exploratory analyses concerning proteins whose concentrations change after starting treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patient was correctly informed about the study, its implementation, objectives, associated restrictions and patient rights
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 1 month of follow-up
* The patient has non-valvular atrial fibrillation that was diagnosed within the last 3 months. Documentation of atrial fibrillation by a 12-lead ECG, an ECG rhythm strip, atrial fibrillation episode lasting at least 30 seconds.
* The patient has a CHA2-DS2-VASc score = 1, that is to say the presence of at least one of the following risk factors: (1) congestive heart failure or moderate to severe systolic dysfunction of the left ventricle; (2) history of systolic blood pressure\> 160 mmHg; (3) diabetes; (4) history of ischemic stroke or systemic embolism; (5) vascular disease (myocardial infarction, arterial disease); (6) age \> 65 years; (7) female.
* The patient will start Rivaroxaban (Xarelto®) at the Nîmes University Hospital

Exclusion Criteria:

* The patient is participating in another interventional study
* The patient has participated in another interventional study within the past three months
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Presence of a mechanical heart valve or valve disease
* Patient who recieved another new direct oral anticoagulant other than Xarelto® in the previous three months
Research Investigating Drug Effects-2 (RiDE-2)

The purpose of this study is to better understand how people's mood, behavior, and brains respond to different recreational drugs. We are also trying to understand why some people may feel differently or their brain may respond differently than other people after taking the same recreational drug.


Eligibility Criteria:
Inclusion Criteria:

* age 18-21 at eligibility visit
* body mass index of 18.5-30
* report using cannabis ≥10 times in their life and ≥1 time in the past 3 months, but \<7 days a week (daily)
* medically and neurologically healthy
* score of ≥0.25 on the Personality Inventory for DSM-5 (PID-5) Anhedonia subscale

Exclusion Criteria:

* positive urine drug screen (UDS; except for THC) and/or positive saliva THC test
* contraindication for fMRI BOLD study (e.g., metal implants)
* severe mental illness (e.g., psychosis, mania, lifetime moderate-to-severe SUD (including moderate-to-severe CUD))
* heavy nicotine use in the past month (\>20 cigarettes per week or electronic nicotine delivery system (ENDS) use equivalent
* night shift work
* females who are currently pregnant confirmed by urine pregnancy test, are planning pregnancy, or are lactating
* unwilling/unable to sign informed consent document
* current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances (Dronabinol/Marijuana/Cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)
* physical or neurological diagnoses (e.g., cancer, diabetes, seizure disorder, Parkinson's, Multiple Sclerosis, loss of consciousness \>10 min., etc.) that in the opinion of the Study Physician and Investigators could increase safety risks or influence the findings
* currently taking any medication that could interact with a single dose of Δ9-THC
Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Study included a 24 week extension that did not occur due to FDA approval of the product.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
* Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.

Exclusion Criteria:

* -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
* Clinically significant outflow obstruction (benign prostatic hyperplasia)
Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer

Strategies to minimize and mitigate external beam radiation therapy related mucositis and pain during the treatment of head and neck cancer remain limited. The investigators hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance on opioid medication, and improve the quality of life for these patients.

The specific aims of this proposed study include the following:

* Evaluate the reduction or delay of mucositis related pain and morbidity with the use of gabapentin in patients with stage III or IV oropharyngeal squamous cell carcinoma undergoing definitive radiation with concurrent chemotherapy as part of their cancer management, compared to standard supportive side effect mitigation - using patient reported quality of life endpoints such as the Patient-Reported Oral Mucositis Symptoms (PROMS) scale.
* Assess morphine-equivalent opioid use in both treatment arms by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation during radiation treatment.
* Report on change in Speech and swallow performance, as measured by the Performance Status Scale (PSS) for Head and Neck Cancer Patients
* Evaluate changes in weight from baseline throughout treatment between the two arms.
* Assess feeding tube requirements during treatment.
* Evaluate the adverse events associated with gabapentin.
* Evaluate the severity of radiation mucositis (grade 3-4, CTCAE, v. 4)

Eligibility Criteria:
Inclusion Criteria:

* Patients being treated with combination chemotherapy and radiation therapy daily for locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.
* Age ≥ 18.
* ECOG performance status ≤ 1.
* Patients must provide study specific informed consent prior to study entry and be able to fill out toxicity and quality of life related questionnaires.

Exclusion Criteria:

* Patients may not be receiving gabapentin, any other investigational agents, or other anticonvulsants.
* Patients with metastatic disease are excluded from this clinical trial.
* Patient with allergies or hypersensitivity to gabapentin.
* Patients receiving surgery as part of their definitive management.
* Patients who have received prior chemotherapy or radiation therapy.
* Patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily.
* Uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.
Phase 1a Study in Healthy Participants

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects.

This is a phase 1a, first-in-human, double-blind, placebo-controlled clinical trial. The primary objective is to assess the safety, tolerability and pharmacokinetic of single dose HS-10506 in healthy subjects. The secondary objective is to observed pharmacokinetic parameters and metabolites after single dose of HS-10506.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants aged from 18 to 45 years
* Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily signed Informed Consent Form
* Males' weight ≥ 50kg, females' weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18\~28 (including the critical value)
* During the study and for 3 months after receiving the last dose of study drug, subjects must agree not to donate sperm or eggs, not to plan to have children, and to use an effective method of contraception

Exclusion Criteria:

* Has a history of chronic or serious disease from neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system or tumor
* Has taken any drugs, including prescription drugs, over-the-counter drugs, herbal preparations, some health products or inhibitor/inducer of CYP3A4 or CYP3A5, within 2 weeks (or 5 half-lives) before screening and throughout the study period
* Has clinically significant ECG abnormalities, such as QT interval corrected according to Fridericia formula(QTcF), \>450 ms (males), \>470 ms (females)
* Has current manifestation of blood pressure or pulse abnormalities in resting state: such as systolic blood pressure \<90 mmHg or ≥140 mmHg, diastolic blood pressure \<60 mmHg or ≥90 mmHg, pulse \<55 bpm or \>100 bpm
Study Evaluating the Clinical and Therapeutic Management of Rheumatoid Arthritis in Spain

This is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be analyzed: individuals who have had RA for two years or less (the "early RA" group) and individuals who have had RA for more than 2 years and who currently meet the ACR criteria for RA (the "established RA" group).


Eligibility Criteria:
Inclusion criteria:

* Group 1: early RA : patients with disease lasting 2 years or less, considered by the investigator as an early RA
* Group 2: established RA: patients with disease lasting more than 2 years who meet the ACR criteria for RA

Exclusion criteria:

* Patients with any rheumatic disease different from RA
* Participation in any clinical trial or study in the last 12 months
Post-Market Study of Alcon Intraocular Lenses

The purpose of the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs.

This observational study will enroll subjects who have been implanted with an Alcon aspheric monofocal or monofocal toric IOL no less than 4 months prior to study procedures. This study will be conducted in Australia.

Eligibility Criteria:
Key Inclusion Criteria:

* In good general health at the screening visit;
* Implanted in both eyes at least 4 months ago with either Vivity/Vivity toric IOL or an Alcon aspheric monofocal/monofocal toric IOL (Acrysof IQ/Clareon);
* Best Corrected Distance Visual Acuity (BCDVA) of 20/25 or better with both eyes together;
* BCDVA of 20/40 or better in each eye;

Key Exclusion Criteria:

* Clinically significant Posterior Capsular Opacity (PCO) as assessed via slit-lamp exam per investigator opinion;
* History of ocular surgery other than cataract surgery and Nd:YAG laser surgery;
* History of amblyopia.
Effect of the Chromium Nicotinate on Type 2 Diabetes

The role of micronutrients in diabetes is not well understood. Studies have demonstrated the relationship between low chromium serum levels and insulin resistance. This study aims to evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients with type 2 diabetes.

Insulin is a hormone secreted by cells β of pancreatic islets in response to increased levels of glucose and serum amino acids. Insulin resistance means a decrease in the ability of insulin to stimulate glucose utilization because is disabled in the insulin receptor, decrease in concentration of receptors or failure mechanism of cell transit. Recently, the discovery of a substance called low molecular weight chromium-binding substance (LMWCr), showed the ability of this substance in amplifying insulin signaling, increasing the sensitivity of insulin receptors in the plasma membrane. This way, the capacity of LMWCr in activating the insulin receptor depends on levels of serum chromium. Thus, the hypothesis that the nutritional status of individual poor chromium contributes to the decrease in glucose tolerance and consequently, for type 2 Diabetes. Thus, it becomes necessary to assess the effect of supplementation of chromium in increased insulin sensitivity in patients with type 2 Diabetes. This is a double-blind randomized clinical trial, consisting of a period of three months of nutritional intervention with chromium nicotinate, biochemical and anthropometric evaluation and assessment of food profile and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Body mass index \> 25 kg/m2
* Increased waist circumference

Exclusion Criteria:

* Subjects on insulin
* Pregnancy
* Patients with chronic complications as heart disease, nephropathy, retinopathy
Study With Advanced Vaginal Tactile Imager

The objectives of this study are:

1. To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;
2. To assess the clinical suitability of the interface software to facilitate the data collection process and to get in vivo examination data for validation of visualization and analysis routines;
3. To test the data collection technique and establish a reliable examination procedure.


Eligibility Criteria:
Inclusion Criteria:

Adult women (over the age of 21) falling within one of the following groups:

1. No evidence of pelvic floor disorder and no prior pelvic surgery;
2. Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment.

Exclusion Criteria:

1. Active skin infection or ulceration within the vagina
2. Presence of a vaginal septum;
3. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
4. Ongoing radiation therapy for pelvic cancer;
5. Impacted stool;
6. Recent (less than three months) pelvic surgery;
7. Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia;
8. Severe hemorrhoids;
9. Surgically absent rectum or bladder;
10. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician.