cyrilzakka/clinical-trials huggingface dataset:
Targeted Antimalarial Drug Administration for Seasonal Migrant Populations in Amhara Region, Ethiopia

The purpose of the study is to assess the effectiveness, feasibility, and acceptability of targeted drug administration for seasonal migrant populations in Metema District, Amhara Region, Ethiopia

A cluster randomized controlled trial will be used to evaluate the effectiveness, feasibility, and acceptability of targeted antimalarial drug administration (TDA) for seasonal migrant farmworkers in the Delello farm sites in Metema district, Amhara Region. Individual farm sites will be randomized 1:1:1 to either of two intervention options or control, where all farmworkers at intervention sites will receive either two or three rounds of dihydro artemisinin piperaquine over the primary farming season.

All study farm-sites will receive enhanced case management conducted by mobile health teams throughout the study period.

Cross-sectional surveys will be conducted in all arms at baseline and 4 to 6 weeks following the third round of TDA to assess the effectiveness of the intervention for reducing parasite prevalence.

Eligibility Criteria:
Inclusion Criteria:

* At the time of the study, be a seasonal farm worker at one of the selected farm sites in Metema district
* Available and willingness to participate in the study and provide consent (or parental/guardian consent and asset in the case of minors)

Exclusion Criteria:

* Severe illness (will be referred for care)
* Inability to provide informed consent
* Age 14-17 years old and not having a parent/guardian at the farm who can provide consent
* Age \<14 years old

Additional exclusion criteria for the intervention group:

* Having received an antimalarial drug within the last 2 weeks
* Having any of the contraindications to receiving DP:

  * History of cardiac rhythm disturbances, bradycardia, or heart failure
  * Concomitant treatment with drugs that prolong the QT interval (fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron, etc.) or drugs containing any of the following: flecainide, metoprolol, imipramine, amitriptyline, clomipramine
  * Known allergic reactions to DP or other artemisinin derivatives
  * Pregnancy
Study on the Interplay Between Twist1 and Other EMT Regulators Through microRNA-29 Family.

Investigation of the molecular mechanism and clinical significance of the interplay between Twist1 and other EMT regulators through microRNA-29 family.

Head and neck squamous cell carcinoma (HNSCC) is one of the leading causes of cancer deaths worldwide, and it ranks the fourth male cancer-related death in Taiwan. In HNSCC, invasiveness and metastasis of cancer cells contribute to the major cause of mortality; therefore, elucidation of the mechanism and development of new strategies against metastasis is the utmost importance in treating advanced HNSCC. Epithelial-mesenchymal transition (EMT) is a process by which epithelial cells lose their polarity and are converted to a mesenchymal phenotype, and recently is considered as the major mechanism for cancer metastasis. The initiation of EMT is hallmarked by suppression of the intercellular junctional protein E-cadherin by a variety of transcriptional factors, including Twist1, Snail, Slug, SIP1, Zeb1 and E47. However, during metastatic evolution, the interplay between different EMT inducers has been investigated limitedly. Previously study demonstrated that hypoxia induces EMT of HNSCC through induction of Twist1 expression. Additionally showed that Twist1 promotes EMT and tumor-initiating capability through upregulation of Bmi1, and co-expression Twist1 and Bmi1 predicts a worse prognosis of HNSCC cases. Accumulated evidence suggests that microRNAs play essential roles in cancer progression and metastasis. Therefore, we aim to investigate the role of microRNA in Twist1-mediated cancer metastasis, and the interplay between Twist1 and other EMT regulators. Our preliminary data showed that the expression of miR-29 family, including miR-29a, b, and c were increased in Twist1-overexpressing HNSCC cells. Furthermore, we discovered that SIN3A, a co-repressor of another EMT regulator Snail, is a target of miR-29s. We therefore speculate that Twist1 modifies the function of Snail through microRNA machinery. In this proposal, we will delineate the regulatory mechanism of the Twist1-miR29s-SIN3A axis. We will also investigate the molecular interplay between Twist1 and Snail through Twist1-miR29s-SIN3A signal pathway. Furthermore, we will elucidate the molecular basis and pathophysiologic significance of Twist1-Snail interaction under hypoxic environment. Finally, we will confirm the in vitro finding by in vivo animal study and HNSCC samples. These results will provide crucial information for understanding the molecular basis of HNSCC metastasis, and will be valuable for developing new therapeutic strategies against advanced HNSCC.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer

Exclusion Criteria:

* pregnant woman
Resistance on Antithrombotic Drugs in Ischemic Heart Disease

The purpose of this study is to determine whether aspirin and clopidogrel resistance measured with Multiplate function analyser has a good correlation with incidence of major adverse cardiac events in patients with coronary artery disease (CAD).

Our plan is to enroll 180 patients with diagnosed CAD who electively undergo percutaneous coronary intervention (PCI). Blood samples will be taken just before the procedure and one day after the procedure and analysed on Multiplate function analyser. Assessing aspirin and clopidogrel resistance incidence using Multiplate platelet function analyzer we will also try to find resistance correlation with the incidence of major adverse cardiac events in a one year follow up.

Eligibility Criteria:
Inclusion Criteria:

* Elective PCI
* \> 7 days on aspirin 100mg therapy before the intervention
* \> 7 days on clopidogrel 75mg therapy before the intervention

Exclusion Criteria:

* Loading dose of clopidogrel
* \< 7 days on aspirin therapy before the intervention
* Myocardial infarction less than 30 days before the intervention
* Cerebrovascular incident less that three months before the intervention
* Haemorrhagic diathesis
* Trc \< 100
* Htc \< 30%
* Creatinine \> 140
Analgesic Efficacy of Different Nerve Blocks in Postoperative Cesarean Section

comparing analgesic efficacy of different nerve blocks on post operative cesarean sections.

Analgesic efficacy of Erector Spinae, Quadratus Lumborum and Intrathecal Morphine for post operative pain relief after cesarean section,

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* more or equal 37 weeks of gestation
* ASA 1,2
* Elective cesarean delivery

Exclusion Criteria:

* Patient refusal
* inability to cooperate with or understand the study
* local infection.
* bleeding disorder
* known anaphylaxis to any drug used in the trial
* ASA physical status more than 2
* emergency operations
* chronic opioid use (opioid use in the past 3 months)
* Neurologic deficit or disorder
* contraindication to regional anesthesia.
Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers

This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be medically documented as healthy at physical examination
* Moderate smokers or non-smokers
* Subjects must be between the ages of 18 and 60
* Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)
* Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females
* Females must be non-pregnant and non-lactating, and either surgically sterile at least 6 months prior to the first study drug administration or post-menopausal for 12 months or greater
* Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner must be willing to use an acceptable contraceptive method throughout the study and for 90 days after the last study drug administration
* Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study administration
* Subjects must have a complete blood count and platelet count within the normal range
* Subjects must have a normal urinalysis
* Subjects must have a normal estimated glomerular filtration rate
* Subjects must have a normal ECG
* Subjects must be able to understand the study procedures, risks involved and be able to comply with the study and follow-up procedures
* Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion Criteria:

* Subjects with any history or clinical manifestations of disorders
* Subjects who have any history or suspicion of kidney stones
* Subjects who are HIV, Hep B or Hep C positive
* History of significant allergic reactions to any drug
* Clinically significant ECG abnormalities
* History of significant drug abuse within 1 year prior to screening or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior to screening
* Subjects who have used prescription dugs, over the counter drugs or herbal remedies within 14 days before day 1
* Positive urine drug screen, alcohol breath at screening
* Subjects had undergone major surgery within 3 months
* Women who are pregnant or breastfeeding
* History of significant alcohol abuse
* Subjects who consumed Seville oranges-or grapefruit-containing food or beverages within 7 days before Day 1 and during the entire study duration.
* Subjects with any condition that, in the judgement of the investigator, would place him/her at undue risk
* Participation in a clinical research study involving the administration of an investigation or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to first dose
* Donation of plasma within 7 days prior to dosing
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula

This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an interventional, open-label, non-comparative multicenter study.

The study comprises a first period of 30 days followed by an optional intervention period of 90 days.

Eligibility Criteria:
Inclusion Criteria:

1. Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:

   1.1 Regurgitations: 1.2 Colic: 1.3 Constipation:
2. Infants born at 35 weeks or more of gestational age
3. Infants up to 4 months of age

Exclusion Criteria:

1. Exclusively or partially breastfed infants (i.e. \&amp;amp;gt; 2 breast feeds per day) with maternal willingness to continue breastfeeding
2. Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study
3. Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)
4. The willingness to take additional pre-, probiotics or thickening agents during the study
5. Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet
6. Infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the patient

(non exhaustive list)
Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment

The purpose of this study is to assess severity of illness in schizophrenia patients in routine clinical practice at the time of entry in the study and after the treatment with Seroquel XR for 8 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Schizophrenia prescribed on Seroquel XR according to the approved product information before inclusion in this non-interventional study
* Signed and dated Patient Informed Consent (ICF)

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients of Seroquel XR
The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania

This study aims to compare the burden of neurocysticercosis among people living with HIV to people not infected with HIV.

People living with HIV and matched HIV negative controls will be tested serologically for cysticercosis, examined neurologically and will undergo CT scanning to determine the prevalence and presentation of NCC.

Furthermore, the immune system response in HIV patients with Taenia solium neurocysticercosis will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who consent to participate in the study and testing.
* Patients of age 14 years and above
* Patient living inside the study catchment area
* HIV-positive patients
* Patient suspected of taeniasis or cysticercosis/neurocysticercosis

Exclusion Criteria:

* Patients with opportunistic infections.
* Study participants taking anthelminthic drugs PZQ and ALB or have received them within the previous 12 months.
* Pregnant women
* Patients that are seriously ill.
* Patients with epilepsy and other mental disorders that impair thoughts and emotions such as psychosis.
Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

The aim of this study is to determine the beneficial effect of mouth rinses, both topical analgesic and saline regimens as an adjuvant therapy in the presence of standard prescription of post-operative pain killers on the progress of socket healing following routine dental extraction.

Hypertension is a highly prevalent cardiovascular disease, which affects over 1 billion people worldwide. It varies with age, race, education and so forth.1 The National Health Survey of Pakistan estimated that hypertension affects 18% of adults and 33% of adults are above 45 years old.2It is a common disease encountered in dental setting. Its wide spreading, terrible consequences, and life-long treatment require an attentive approach by dentists. Knowledge of hypertension is important for dentists especially for risk assessment for dental treatment. This may lead to improved monitoring and treatment.

Dental treatment in hypertensive patients necessitates special attention, because any stressful procedure may increase blood pressure and trigger acute complications such as cardiac arrest or stroke. Extractions are usually done for teeth which are not salvageable. Dentists routinely advice use of warm saline rinses to help in healing of post extraction socket. But for hypertensive patients this recommendation is potentially harmful There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Moreover, advantage of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects requiring simple tooth extraction (elevator or forceps) which were either known cases of controlled hypertension under medical treatment or confirmed non hypertensives.

Exclusion Criteria:

* Subjects requiring surgical tooth extraction involving bone removal and suturing, uncontrolled systemic disorders (diabetes mellitus, hypertension, blood coagulopathies, metabolic bone disorders), on platelet aggregation therapy or warfarin (anticoagulants) or bisphosphonate therapy.
The Impact of High-Fat Ketogenic Diet and Low-Fat Diet in Women Body Weight

The aim of this study is investigated the effect of high fat Ketogenic Diet (HFKD) in weight reduction compared to the low-fat diet (LFD) among Saudi overweight and obese women. A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD or LFD for 12 weeks.

Obesity is associated with an increased risk of high blood pressure and heart muscle damage, which leads to cases that increase the chances of developing cardiovascular diseases, and if weight gain is not controlled, these results lead to obesity is the main cause of cardiovascular disease and causes dyslipidemia, high blood pressure and diabetes. Recently, there have been followed systems and programs food some of which are beneficial for health and some of them are unhealthy systems. The diet is one of the most controversial issues. The aim of this study is investigated the effect of high fat Ketogenic Diet (HFKD) in weight reduction compared to the low-fat diet (LFD) among Saudi overweight and obese women. A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD or LFD for 12 weeks. Our primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of body weight, the percentage of body fat, The secondary outcomes have evaluated at the percentage of body fat, blood glucose, lipid profile.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Overwight and obese wonen
* aged 18 and 40
* BMI 25 and 34.5 kg m2
* fat parentage above 30% .

Exclusion Criteria:

* Man
* women in normal weight or BMI less than 25 and 34.5 kg m2
* Breastfeeding and pregnant women
Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients

A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2


Eligibility Criteria:
Inclusion Criteria:

* Those who voluntarily signed the informed consent to participate in this study.
* Adults aged 19-75 years.
* Those diagnosed with type 2 diabetes mellitus.
* 7% ≤ HbA1c ≤ 10.5%
* FPG ≤ 270 mg/dL
* BMI ≤ 40 kg/㎡
* Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.

Exclusion Criteria:

* Those who suffered from acute or chronic metabolic acidosis, lactic acidosis and diabetic ketoacidosis.
* Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
* Those with heart failure (NYHA class II\~IV) or who had suffered from heart failure.
* Those with a history of malignant tumor within 5 years
* Those who have a clinically significant liver disease
* Those who have a clinically significant renal disease
* SBP \> 180 mmHg or DBP \> 110 mmHg
* Those who had allergic reaction to main ingredients or components of the investigational products.
* Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
* Females who are pregnant or breastfeeding.
* AST or ALT ≥ LRN\*3
* TG ≥ 500 mg/dL
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants at least 18 years of age.
* All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
* Participants must sign an informed consent form (ICF).
* Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
* Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
* Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.

Exclusion Criteria:

* Participants who received any investigational new drug in the 30 days prior to screening visit.
* Females who are pregnant or lactating.
The Impact of Family Financial Support on Parental Mental Health

The investigators have partnered with financial coaching organizations to establish what the investigators have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on mental health using the Kessler-6 emotional distress scale.

Financial coaching is a new tool in the field of community development, but it has already demonstrated significant financial impact in a number of studies, including one randomized trial conducted by the Urban Institute. Financial coaching improves participant financial literacy, budgeting, saving for financial emergencies, and debt level. The investigators' project will help clinicians and the field of community economic development understand health and well-being through a new economic lens and assess the health-related impacts of the emerging field of financial coaching. The investigators have partnered with financial coaching organizations to establish what they have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on mental health using the Kessler-6 emotional distress scale as the outcome variable.

Community-based participants will be recruited from South Los Angeles and randomized to receive either monthly financial coaching plus access to referral for social services (intervention) or access to referral for social services alone (control). Inclusion criteria include having dependents under age 18, having some form of income, and having a tax identification number (social security number or Individual Tax Identification Number). Participants will be surveyed quarterly regarding their mental health using the Kessler-6 emotional distress scale.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers/Parents with one or more child dependents, income of any sort, and a tax identification number.

Exclusion Criteria:

* Inability to partake in financial coaching due to physical limitations or primary language other than Spanish or English.