cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Comprehensive School Health Programme in Zambia

In Zambia, the health and well-being of children aged 5 to 14 has often been overlooked, leading to various health challenges affecting their development and education. The Healthy Learners (HL) program, in collaboration with the Zambian Government, aims to address this gap by implementing a comprehensive school health program. Trained teachers, known as school health workers (SHWs), play a key role by delivering health education, coordinating preventative care with local clinics, and overseeing a 'school health room' for sick students.

This study is a large cluster-randomized control trial in 225 schools. The goal of this trial is to compare the effects of the comprehensive school health programme (SHP) developed by HL against two alternatives: the current level of school health provision and the current school health activities enhanced with deworming and vitamin A coordination by HL, with their technical and financial support ensuring the reliable delivery of all health activities currently planned by the government.

1. What is the impact of the program on health-seeking, health, and education outcomes?
2. What are the indirect effects of the program on teachers and clinics?
3. What is the added value of such a comprehensive SHP, compared to (i) optimized (ii) or imperfect (status-quo) delivery of a limited range of school health activities (e.g., deworming and vitamin A supplements)?
4. How costly is the comprehensive SHP, and what factors affect its implementation?
5. What are the potential benefits of the program for long-term human capital accumulation (learning, well-being etc)?


Eligibility Criteria:
* Schools: eligible for SHP (not inaccessible in the rainy season, within 10km of health centre)
* School administrator: has at least one year experience in school and is the primary or deputy school manager (e.g., headteacher, deputy headteacher, senior teacher acting as financial officer)
* Learners: registered and in attendance in school during baseline, in grade 1, grade 3, or grade 5
* Parents, primary caregivers or guardians of selected learners. Guardians are eligible if they stay with the child and make schooling and health decisions for the child in the absence of parents/primary caregivers.
* Teachers: any teacher employed by study eligible schools (not volunteers)
* Health facilities: designated facilities in the catchment area of study schools
* Health facility staff: any staff doing OPD consultation present during facility data collection days
Hepatitis C Screening in the Primary Care Setting

The purpose of this study is to determine whether patient education improves Hepatitis C screening in the primary care setting.

Hepatitis C is a chronic, asymptomatic infection that progresses to liver cirrhosis and cancer in the later stages if left untreated. The Centers for Disease Control (CDC) recommends a one-time screening for high risk birth cohort between the years 1945-1965. Prior studies have evaluated methods to improve screening for hepatitis c with focus on increasing awareness in health professionals. Targets included nursing staff and electronic medical records. This study targets providing patients with education resources to see if screening rates improve.

Eligibility Criteria:
Inclusion Criteria:

* All patients born between the years 1945 and 1965.

Exclusion Criteria:

* Patients who had already received a prior screening test for Hepatitis C before the office visit.
Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.

OBJECTIVES:

* Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma.
* Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor)

  * Stage III or IV disease
  * Persistent or recurrent disease
* Documented disease progression
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

  * At least 1 target lesion

    * Tumors within a previously irradiated field are not considered target lesions unless there is documented disease progression
* Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any active GOG phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* GOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3

Hepatic

* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN

Renal

* Creatinine ≤ 1.5 times ULN

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No sensory or motor neuropathy \> grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior cytotoxic chemotherapy for uterine sarcoma

Endocrine therapy

* At least 1 week since prior hormonal therapy for uterine sarcoma
* Concurrent hormone replacement therapy allowed

Radiotherapy

* See Disease Characteristics

Surgery

* Not specified

Other

* Recovered from all prior therapy
* No prior anticancer therapy that would preclude study therapy
Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries

The objective of this study is to demonstrate the safety and performance of the Indigo Aspiration System using the CAT RX aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion who are referred for Percutaneous Coronary Intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 years
* Patient presents to treating facility within 12 hours of symptom onset
* High thrombus burden at coronary angiography, defined as TIMI thrombus grade 4 or 5 by physician visual estimate after the guidewire crosses the target lesion
* Frontline treatment with the Indigo® Aspiration System using the CAT RX Aspiration Catheter, prior to standard of care PCI
* Target lesion is located in a native coronary artery
* Informed consent is obtained from either patient or legally authorized representative (LAR)

Exclusion Criteria:

* New onset of stroke symptoms and NIHSS \> 2, prior to index procedure
* Treatment with fibrinolytic therapy for index coronary vessel occlusion
* Life expectancy less than 6 months due to any comorbidities
* Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
* Participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
* Patient is pregnant
Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

Efficacy of transcranial direct current stimulation (tDCS) combined with complex (cognitively engaging) walking exercise in older adults. The primary outcome measures are executive function (computer-based assessment battery) and complex walking function (speed on an obstacle negotiation task). This will be a two-site trial conducted at the University of Florida (lead site) and Brooks Rehabilitation Hospital, which is necessary to achieve enrollment targets and will allow us to develop a multi-site research infrastructure for a future Phase 3 multi-site trial. The study will enroll up to 120 older adult women and men, who exhibit mild to moderate decline of executive function. All experimental groups will receive the same complex walking intervention, which will focus on use of cognitively engaging tasks such as obstacle crossing, accurate foot placement, and walking on complaint surfaces. Each session will consist of 30 minutes of walking. For tDCS, the active treatment group will receive 20 minutes of 2mA tDCS over prefrontal regions F3/F4 ("treatment group"). The second group is a sham control group. tDCS will be delivered simultaneously with complex walking exercise for 18 sessions over a 6-week period. Assessments will be conducted at baseline, post intervention (within one week), and 12 weeks post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 65+
* Objective executive function decline, based on standardized cognitive assessments.
* Subjective cognitive decline, based on the question: "During the past 12 months, have you experienced confusion or memory loss that is happening more often or getting worse?"
* Ability to walking independently for 6 minutes (use of cane permitted)

Exclusion Criteria:

* Major cognitive disorder that interferes with independence
* Percentile score less than 10th percentile on standardized cognitive assessments
* Medications that are thought to influence tDCS neuroplasticity.
* Contraindications to tDCS or MRI.
A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care

This study tests the feasibility, acceptability, and preliminary efficacy of using a brief pamphlet in the primary care waiting room focused on promoting patient-initiated weight-related discussions in primary care appointments.

Obesity is a chronic and complex disease that many national and professional organizations recommend be discussed frequently in primary care. However, rates of weight-related communication in primary care are suboptimal. When patients and physicians communicate about weight (defined as usage of any the 5As-ask, assess, advise, agree, and/or assist-in a weight-related conversation), patients are more likely to improve dietary habits, demonstrate more motivation for health behavior change, attempt weight loss treatment, and lose more weight as compared to patients who do not engage in weight-related communication with their physicians. Interventions have attempted to increase the rates of weight-related communication in primary care. However, they have focused solely on physicians and have only yielded modest efficacy. Intervention with patients on proposed patient-related barriers may be key to improving the rate of weight-related communication in primary care. The waiting room prior to appointments is an underutilized intervention setting. Prior waiting room interventions have shown promising results for increasing health communication between patients and physicians. However, no prior study has focused on weight-related communication. Thus, this study aims to test the feasibility, acceptability, and preliminary efficacy of an experiential pamphlet delivered in the waiting room targeting patient-related barriers to weight communication.

Eligibility Criteria:
Inclusion Criteria:

* Present for an appointment at the Family Medicine Office
* Indicate that they can speak and read English
* Indicate that their Shape is \> or = 5 on measure (Stunkard, Sørensen, \& Schulsinger, 1983)
* Indicate that they are 18 years or older

Exclusion Criteria:

- Indicate that they are Pregnant
C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies

The complement C1q tumor necrosis factor-associated protein-9 (CTRP-9), which is responsible for regulating cardiovascular and metabolic functions, increases vascular relaxation by pathway dependent on AMPK / endothelial nitric oxide synthesis (eNOS). The aim of this study was to investigate CTRP-9 levels in pregnant women with preeclampsia.

The most important reason for the development of preeclampsia is the problem of trophoblastinvasion and consequent formation and development of placenta is not healthy

Cytokines are regulatory molecules that have effects on cell functions.Cytokines are molecules that also regulate endothelial functions. Placenta formation and widespread endothelial damage are under the influence of cytokines.

Therefore, there may be important links between impairment or imbalance in cytokine release and function and the formation of preeclampsia.Nitric oxide (NO) is a biologic enzyme that is synthesized by nitric oxide synthase (NOS) from the amino acid of L-arginine and exists in all mammals.

e(NOS) is the three isoforms of NO. It is known that NO is a major vasodilator of pregnancy, inhibiting platelet and leukocyte aggregation.There was a decrease in NO levels in preeclamptic patients.

The CqP / TNF Binding Protein (CTRP) family consists of 15 members, and is synthesized in many organs outside the body of fat.CTRP9 is predominantly excreted in fat tissue, and levels in circulation are reduced in patients with diabetes and obesity.Many studies have shown that CTRP9 exerts beneficial effects on metabolic and cardiovascular homeostasis.

CTRP9 increases vascular relaxation in the AMPK / endothelial nitric oxide synthase (eNOS) dependent pathway. CTRP9 has also been reported to reduce inflammatory responses in endothelial cells via the AMPK-dependent pathway.

Vasorelaxation due to CTRP9 is endothelium-dependent and NO-mediated. CTRP9, directly acting on smooth muscle, is indirectly or indirectly associated with NO production in the vascular endothelial layer by stimulating vasorelaxial molecular production by endothelial cells.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are ages 15-40
* BMI ≥35 kg/m2 and BMI\<25 KG/m2 pregnants
* The clinical diagnosis of preeclampsia will follow the current criteria outlined by ACOG 10
* \> 20 th weeks of pregnancy

Exclusion Criteria:

* A previously known chronic metabolic disease (diabetes, pregestational dyslipidemia, hypertension,)
* collagen vascular diseases,
* inflammatory bowel disease
* chronic inflammatory conditions,
Dietary Phosphate and Serum Phosphorus

Overall study design is to review National Health and Nutrition Examination Survey (NHANES) data 1999-2008 for nutrition risk according to kidney function. Substudies will be performed to review the association of nutrients and overall dietary intake compared to biomarkers available in NHANES during this period.

Data from NHANES 2003-2006 were used to evaluate the relationship between estimated dietary phosphorus intake and the measured serum phosphorus. The following variables were used:

1. Demographics: Age, sex, race/ethnicity
2. Dietary variables: Foods, food groups (as reported by the United States Department of Agriculture (USDA) method, further standardized to the Academy of Nutrition and Dietetics method for portion size and then divided into groups having inorganic phosphate additives or no inorganic phosphate additives), food weight (g), phosphorus (mg), dietary supplements
3. Socioeconomic variables: education, family income
4. Laboratory variables: serum creatinine, phosphorus; urine albumin, creatinine
5. Clinical assessments: hypertension (proportion having blood pressure ≥140 millimeters of mercury (mmHg) diastolic or ≥90 mmHg systolic or taking antihypertensive medications); hyperglycemia (proportion having serum glucose \>126 mg/dL or taking medications for diabetes); kidney function based on Chronic Kidney Disease Epidemiology Collaboration (2009) equation, evaluated in 15 milliliters/min/1.73m2 increments from \<15 to \>105; anthropometrics (BMI, kg/m2; obesity class I, II, III)

Eligibility Criteria:
Inclusion Criteria:

* Serum creatinine

Exclusion Criteria:

* Pregnancy
* No dietary intake interview
* Dietary intake interview not valid
* Answered the question "Have you had dialysis in the past year?" as "Yes"
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone\>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

* 40% reduction in the base iPTH level is achieved, and/or;
* serum iParathormone level \< 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) \> 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)\>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P\>65 mg\^2/dL\^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \>= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone \> 300 pg/mL.
* Subject is receiving chronic hemodialysis.
* Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
* Subject has provided their informed consent to participate.

Exclusion Criteria:

* Subject has a corrected serum calcium \> 10.5 mg/dL, serum phosphorus \>= 6.5 mg/dL or subjects with corrected Ca x P \>= 65 mg\^2/dl\^2.
* Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
* Subject has participated in clinical study within the last month.
* Zemplar is contraindicated according to the Summary of Product Characteristics.
Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps

This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.

This is a 24-week, prospective, open-label, multi-center, single-arm, observational, post-marketing surveillance study under routine clinical practice and does not impose a therapy, visit, or assessment. The study design was approved by the Korean health authority. The purpose of this study is not to answer scientific hypotheses, but to describe the incidences of all potential adverse events (AEs), serious adverse events (SAEs), and unexpected AEs not listed in the local label information occurring in Korean patients under routine clinical practice following the approved local label information.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged ≥18 years
2. Patients with CRSwNP who are not adequately controlled with conventional therapy (INCS)
3. Patients prescribed with Xolair® as per the locally approved label information.
4. Patients who provide written informed consent to participate in the study

Exclusion Criteria:

1. Patients who do not provide consent to participate in the study
2. Patients participating in other clinical trial
3. Contraindications listed in the locally approved label information of Xolair®

   * Hypersensitivity to the active ingredient or any other ingredient of Xolair®
   * Patients with myocardial infarction or history of myocardial infarction (pre-filled syringes only)
Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study

The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can serve as a predictor to identify 'good responders' to acupuncture early in therapy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women with a progesterone-coated intrauterine device (Mirena), and
* Men greater than or equal to 18 years old.

Exclusion Criteria:

* Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture.
* Treatment of a pain condition with pain medication.
* Regular use of benzodiazepines.
* Skin diseases, such as scleroderma, psoriasis or eczema.
* An adverse event due to acupuncture therapy.
* Pregnant women.
* Women without a progesterone-coated intrauterine device (Mirena).
* Anyone older than 60 years of age, fatigued, with a pacemaker ICD, artificial joint, prolonged bleeding time/hemophilia, open wounds, or a known susceptibility to profound analgesia after acupuncture treatment.