cyrilzakka/clinical-trials huggingface dataset:
UNCPM 22322 - Adaption of the Transition of Care Model for Post-Discharge HIV-NCD Care in Lilongwe, Malawi - MLATHO

This is an implementation research study that will adapt and pilot test the Transitional Of Care Model (TCM), originally conceived and developed in the USA, for targeted use as a post-discharge intervention for adults hospitalized with comorbid HIV and NCDs in Malawi using a mixed methods approach.

This study will enroll 75 consecutive adults hospitalized with comorbid HIV and at least have one common cardiometabolic condition (e.g., hypertensive urgency, heart failure, stroke, or diabetes) and provide them with the adapted TCM according to the SOP developed in the prior phase. It is expected that 15-20% will also have comorbid opportunistic infections.

The study will evaluate the acceptability and feasibility of the adapted intervention.

Using mixed methods, including surveys and interviews, the study will evaluate the acceptability and feasibility of providing the inpatient and post-discharge components of the adapted TCM. The study will also describe key 3-month post-discharge clinical outcomes (mortality, readmission) and indicators that may mediate clinical outcomes (linkages/retention in care, adherence to antiretroviral therapy/non-communicable disease (ART/ NCDs) medications, dual control of HIV and NCDs, social demographic variables). Clinical outcomes and indicators in the pilot participants will be compared with a comparable historical control group of patients who had routine care at KCH in the recent past.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* living with HIV
* admitted to internal medicine
* has at least a cardiometabolic NCO as the primary or secondary reason for admission based on the HIV inpatient consultation

Exclusion Criteria:

* patients living beyond Lilongwe urban
Combination Treatment With BTL-899 and HPM-6000UF Devices

This study will evaluate the clinical efficacy of the BTL-899 and HPM-6000UF devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in elderly patients.

The study is a prospective, multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete seven (7) treatment visits and two (2) follow-up visits - 1 month and 3 months after the final treatment.

At the baseline visit, medical history will be assessed. Inclusion and exclusion criteria will be verified, and informed consent will be signed. Digital photographs will be taken, waist circumference will be measured, abdominal muscle strength will be measured with a pressure biofeedback device.

The two devices will be used separately in two different treatments. However one treatment visit can comprise both treatments. The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered. The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered. There will be three (3) visits where both treatments will be applied consecutively, starting with BTL-899, followed by the therapy with HPM-6000UF.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged 60 years or older (postmenopause when female),
* BMI ≤35kg/m2 seeking treatment for strengthening their pelvic floor or abdominal muscles
* Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form.
* Subjects willing and able to abstain from partaking in any concurrent treatments on abdomen and pelvic floor other than the study procedures during study participation.
* Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs taken.

Exclusion Criteria:

* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
* Metal implants in the treated area
* Drug pumps
* Malignant tumor
* Pulmonary insufficiency
* Injured or otherwise impaired muscles in the treated area
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations in the treated area
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Poor healing and unhealed wounds in the treatment area
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Graves' disease
Drug Eluting Stent (DES) in Primary Angioplasty

Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI) referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is responsible for the need of repeat intervention. Both Sirolimus-eluting stents (SES) and Paclitaxel-eluting stents (PES) have been proven to virtually abolish in-stent restenosis in elective patients in simple e more complex lesions. Both SES and PES have raised concerns regarding occurrence of late stent thrombosis, especially in complex lesion subsets or in high risk patients. The PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in primary angioplasty (PASEO) trial was a prospective, single-center, randomized trial evaluating the benefits of SES or PES as compared to BMS implantation in patients undergoing primary angioplasty for acute STEMI. From 1 October 2003 we randomized with 1:1:1 ratio, 270 patients with STEMI and treated with pPCI, to implantation of a bare metal stent (BMS n=90), PES (n=90) or SES (n=90).


Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms of STEMI, with initial onset of chest pain within the past 12 hours, an ECG demonstrating \> 0.1 mV ST-segment elevation in 2 or more contiguous leads or documented new left bundle-branch block and were suitable candidates for percutaneous revascularization.

Exclusion Criteria:

* Active internal bleeding or a history of bleeding diathesis within the previous 30 days
* An history of intracranial hemorrhage
* Intracranial neoplasm
* Arteriovenous malformation or aneurysm
* Known allergy to sirolimus
* Paclitaxel
* Heparin, aspirin, or clopidogrel
* An history of stroke within 30 days or any history of hemorrhagic stroke
* History, symptoms, or findings suggestive of aortic dissection, fibrinolytic therapy within 24 hours
* History of thrombocytopenia, pregnancy, patients on warfarin or acenocoumarol within the last seven days
* Inability to obtain the informed consent
The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope

Horizontal sectioning of scalp biopsy is a better method for evaluating hair disorders than vertical sectioning because it enables the quantitative examination of hair follicles at different stages. Without having the quantitative data of normal scalp hair counts as controls, it is impossible to evaluate scalp biopsies for hair disorders. In recent years, trichoscope is more popular in analysis of hair disease. It is less invasive and simple. The aim of this study is to understand the pros and cons of trichoscpoe.


Eligibility Criteria:
Inclusion Criteria:

* 20-50y/o adults without any scalp disorder

Exclusion Criteria:

* adults with any scalp disorder
Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer

The primary objective of this study is to determine the efficacy \& toxicity of combined docetaxel \& capecitabine as primary chemo for subjects w/ stage II-III breast cancer.

The primary objective of this study is to determine the efficacy \& toxicity of combined docetaxel \& capecitabine as primary chemotherapy for subjects with stage II-III breast cancer.Subjects will be randomized into one of two groups: Docetaxel followed by four cycles of docetaxel \& capecitabine vs. capecitabine followed by four cycles of docetaxel and capecitabine.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the breast w/ Stage II-III disease w/ a primary tumor \>/=2cm or clinically palpable axillary lymph nodes.
* Pre-treatment core or incisional bx w/ adequate tissue for histology \& genomic/proteomic analysis.
* Primary tumor must be bi-dimensionally measurable by physical exam or dx breast imaging. Measurements must be obtained w/in 3 wks prior to study entry.
* Adequate organ fxn:AGC\>1500; Hb\>/=9.0;plts\>/=100K; Crt\</=2.0;Cacl Crt Clr\>/=50; total bili\</=ULN; LFTs\<2.0 ULN
* ECOG performance status 0-1
* Neg. pregnancy test

Exclusion Criteria:

* Pts may not have had definitive primary surgery.
* Metastatic breast cancer
* Any prior chemo or hormonal therapy for breast cancer
* Prior history of malignancy w/in the previous 5 yrs.
* No active unresolved infection
* No major surgery w/in 2wks of start of study
Efficacy of Keppra for Neonatal Seizures

The purpose of this research study is to learn how well the medication levetiracetam (Keppra) works to treat seizures in full term and premature babies. Levetiracetam is commonly used in babies with seizures at Cincinnati Children's Hospital, especially if the seizures have not been stopped by other medicines. The Food and Drug Administration (FDA) has approved the use of levetiracetam for older children (over the age of 4) but not for infants. Even though it is not FDA approved for this age group, doctors at Cincinnati Children's use the medicine as a second drug in babies whose seizures are not stopped by phenobarbital. Some doctors are concerned that phenobarbital is not the best medicine to treat seizures in babies, so researchers are trying to study other medicines.

In this study, the investigators are looking at how well levetiracetam stops or slows down seizures in babies. The investigators are also studying the blood levels of levetiracetam to learn more about how the medicine is processed by the body and what level of medicine in the body works to stop seizures. The investigators are checking labs before and after giving the dose to make sure the medication does not cause any changes in blood counts, kidney function, or liver function. The investigators are following all of the babies in the study after hospital discharge to see if the parents notice any side effects of the medication. Babies in the study will come back to the High Risk Follow Up Clinic at Cincinnati Children's at 6 months of age for a visit with a neurologist and a neonatologist and developmental testing.


Eligibility Criteria:
Inclusion criteria:

* Gestational age ≥ 35 weeks
* Postnatal age ≤ 30 days
* Birth weight ≥ 2000 grams
* Clinical or electrographic seizures of any etiology requiring treatment with an antiepileptic medication (as per the judgment of the clinician caring for the patient)
* Parental consent obtained

Exclusion criteria:

* Infants with renal insufficiency indicated by serum creatinine \> 2.0 (as part of pre-screening, labs obtained as part of routine care will be reviewed. Infants who have not had a creatinine drawn will have one drawn as part of the study after consent is obtained. If the baby requires levetiracetam emergently before the results of the creatinine are back, the dose will still be given and levels will still be drawn as per the protocol.
* Infants who have previously received levetiracetam
* Parents refuse consent
A Training Set for the HRD Model in EOC

A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Pathological confirmation of epithelial ovarian cancer
* With available tumor tissues
* Given consents to participate the study

Exclusion Criteria:

• Not meeting all of the inclusion criteria
A Controlled Trial to Evaluate the Benefits of CrossFit in People Who Work Predominantly in a Sedentary Manner.

People who predominantly sit down often suffer from spinal complaints. This is mainly caused or intensified by a lack of exercise and a shortened posterior muscle chain.

This study aims to investigate whether CrossFit can improve physical deficits, reduce pain, and improve quality of life.

For this purpose, 30 test persons should take part in regular CrossFit training twice a week over one year. In addition, as a control group, 30 persons are also observed who exercise according to their ideas.


Eligibility Criteria:
Inclusion Criteria:

* Predominantly sedentary work
* Willingness to participate in CrossFit training

Exclusion Criteria:

* Medical reasons against participating in regular exercise
* Acute severe injuries to the musculoskeletal system (e.g. broken bones, torn tendons)
Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy

One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins diet have been shown to be effective alternative treatments in children with refractory epilepsy. However, these need parents to be educated, and understand complex instructions of weighing foods and diet preparation. Therefore, children with parents with low levels of literacy and poor socioeconomic status have not been able to benefit from these therapies. Also, the paucity of trained dieticians and limited availability of labeled foods in resource-constraint settings has made these dietary therapies even more inaccessible.

This study aimed to to develop a simple-to-administer variation of the modified Atkins diet for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of this simplified modified Atkins diet in children with refractory epilepsy in a randomized controlled open-label trial.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 2 - 14 years.
2. Seizures persisting daily or more than 7 per week despite the use of at least 2 anti-epileptic drugs in appropriate doses and levels (whenever available) in suitable to the syndrome and EEG findings.

Exclusion Criteria:

1. Known or suspected inborn error of metabolism:

   Patients with clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination With or without 2 or more of the following biochemical abnormalities High blood ammonia (\>80mmol/L), High arterial lactate (\>2 mmol/L), metabolic acidosis (pH \<7.2), hypoglycaemia (blood sugar \<40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.

   In such patients, blood tandem mass spectrometry or urine gas chromatography mass spectroscopy (GCMS) will be obtained to look for inborn error of metabolism.
2. Surgically remediable causes of epilepsy such as tumors, cortical dysplasias, mesial temporal lobe epilepsy etc with refractory focal epilepsy.

   We will perform MRI brain, and short term video-EEG in all patients with focal seizures to look for surgically remediable causes.
3. Motivational or psychosocial issues in the family which would preclude compliance
4. Systemic illness- chronic hepatic, renal or pulmonary disease
Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments

The study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE), and group 2 (SW). Then each main group was equally subdivided into three equal subgroups (n=9) according to the applied dentin dressing material as follows: Subgroup 1: Nano-silver compound (NSC), Subgroup 2: Chitosan-loaded nano hydroxy apatite (CS/N-HAp), Subgroup 3: Bioactive glass ionomer (N-BAG/GIC). At the first visit both groups received the same treatment of incomplete caries excavation, application of dentin dressing materials and sealing temporarily for 3-months with a glass ionomer cement (GIC). At the second visit the GIC reduced pulpally in (SE) group leaving 2 mm as base and completely removal the remaining carious lesion in (SW) group then re-application of same dentin dressing material on each tooth and GIC as a base. Finally, all cavities were restored with selective enamel etching technique, after which self-etch adhesive and Nano-filled composite resin are applied according to manufacturer instructions. The clinical and digital radiographic evaluations of the success and failure rates were performed at: baseline (7 days), 3, 12, and 18-months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with first and second molars with occlusal deep carious lesions (Class I) extending to the inner third of dentin thickness on radiographic examination using (i-sensor H1, Woodpecker, China).
2. Teeth with a healthy response to the electrical pulp tester (DY 310, Denjoy Dental CO., LTD, China).
3. Teeth with the absence of spontaneous pain.
4. Teeth with a negative sensitivity to percussion.
5. Teeth with the absence of periapical lesions by a digital radiographic examination.
6. Clinically, all teeth were without any mobility.
7. Patients who will complete the procedure of follow up.
8. Patients who will sign the consent.

Exclusion Criteria:

1. Mutilated teeth or teeth with caries extending subgingivally.
2. Teeth with the existence of previous restorations.
3. Teeth with periodontal disease, any swelling, fistulas, signs of irreversible pulpitis or necrotic pulp.
4. Teeth with roots showing external or internal resorption.
5. Pregnant women.
6. Presence of any systemic disease.
Chat-based Instant Messaging Support Health Education Program

The purpose of this study is to explore the effectiveness of a CKD-specific chatbot-based instant messaging support health education (CIM-SHE) program and determine its user evaluation by CKD patients.

A pre- and post-study design was employed and 60 patients were invited to join a three-month program for chronic kidney disease health education; 55 successfully completed the intervention. Data were collected from April to November, 2020, using a structured questionnaire. Paired t-tests and generalized equation estimation were used to examine the intervention effectiveness and users' evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. adults over 20 years old
2. diagnosed chronic kidney disease
3. the ability to operate technologies
4. intact cognition

Exclusion Criteria:

Who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.
Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.

This is a phase II,single center,prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that quinolones antibiotics can increase anti-tumor effect. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.

Eligibility Criteria:
Inclusion Criteria:

* Female ≥ 18 years, ≤70 years.
* Has measurable metastatic MBC, with at least 1 measurable lesion per RECIST criteria.
* Fail first-line or above anti-tumor treatment
* Evaluation is stable disease with a trend of progression.
* Minimum life expectancy 16 weeks
* Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis
* ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks
* Normal organ function.
* Has signed a Patient Informed Consent Form

Exclusion Criteria:

* Hypersensitivity to moxifloxacin or other quinolones.
* Tendon damage,peripheral neuropathy,myasthenia gravis.
* Rapidly progressive visceral disease not suitable for further therapy.
* Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
* With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
* Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
* Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
* Researchers consider it is not suitable for participation.
Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness

Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic effect on the human body and mind. Following discharge from an ICU, patients suffer from varying degrees of weakness and muscle wasting. It can take many months before their strength returns to something like before they were ill. This weakness can have important consequences on an individual, affecting their ability to perform routine tasks (e.g. housework, shopping), and whether they can return to work or not. Not surprisingly, this inability to perform activities they used to do prior to their illness can have knock on effects on their mental well being and confidence.

What the investigators hope to see through this study is whether or not patients can recover their ability to perform exercise more quickly following an ICU admission if they undergo an exercise-based rehabilitation programme. The investigators also hope to see whether taking part in a rehabilitation programme has any affect on physical and mental well being.

The investigators hope to use a simple exercise test on a bicycle to assess subjects ability to exercise shortly after leaving hospital. We will then repeat the test after a period of physiotherapy lead rehabilitation to see if they have received any benefit from the programme. The investigators hope to show that by undergoing an exercise-based rehabilitation programme subjects will recover their ability to exercise more quickly than those who do not.

By means of questionnaires the investigators hope to see what effect the rehabilitation programme has had on participants physical and mental well being.


Eligibility Criteria:
Inclusion Criteria:

All patients over the age of 18

* admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU)
* Invasively ventilated ≥ 5 days

Exclusion Criteria:

* Physical condition resulting in an inability to perform a cardio-pulmonary exercise test (CPET) or to participate in the rehabilitation classes,
* Psychiatric condition or impairment not allowing informed consent or compliance with the rehabilitation programme,
* Participation in an alternative rehabilitation programme,
* Terminal illness
* Poorly controlled cardio-respiratory disease