cyrilzakka/clinical-trials huggingface dataset:
The Effect of Malaria on Disease Progression of HIV/AIDS

The purpose of this study is to find out whether malaria affects how HIV/AIDS disease progresses in an infected patient, and to determine the effect of reducing malaria infection on HIV disease progression in Kumasi

Malaria and HIV are among the most prevalent infectious diseases in sub-Saharan Africa and are major causes of morbidity and mortality in the sub region. Because of the wide-spread geographical overlap in HIV and malaria, the probability for co-infections and the potential for interactions between the two diseases are high. Even modest interactions may have substantial impact in populations.

It is now clear that there are interactions between the two infections. HIV associated immunosuppression erodes the malaria acquired immunity of the HIV patients. The risk of parasitaemia, high parasite density and malarial fever increases with decreasing CD4 T cell counts and increasing viral load of HIV patients. Plasmodium falciparum has been shown to stimulate HIV replication through the production of cytokines (including interleukin 6 and tumor necrosing factor α (TNF-α)) by activated lymphocytes. Malaria treatment in HIV patients with malaria resulted in significant reduction of the median HIV viral load concentration.

Although it is now clear that malaria causes transient rises in HIV-1 viral loads, could repeated episodes of malaria in areas of intense transmission lead to a cumulative effect on viral load and accelerate decline in CD4 counts thereby accelerating HIV disease progression? If so, could the decline in CD4 count in individuals who have not yet started on anti-retroviral drugs be slowed down by intermittent malaria treatment?

A controlled interventional study with mefloquine as malaria prophylaxis for 6 months will be used in HIV/AIDS patients who are not already on ARTs in KATH, and malaria parasitaemia and density, HIV viral load and CD4 cell count will be monitored in both arms.

Comparison: Malaria parasitaemia and density, HIV viral loads and CD4 cell counts will be compared between the intervention group and the control groups to determine the effect o malaria and malaria prophylaxis on HIV disease progression

Eligibility Criteria:
Inclusion Criteria:

* Adult HIV patients attending the Komfo Anokye Teaching Hospital (KATH) HIV clinic who do not yet fulfil the criteria for ARTs. This includes a CD 4 cell count of ≥ 300x106/l and World Health Organisation HIV stage I-III

Exclusion Criteria:

* All children with HIV infection attending the HIV clinic at KATH
* Adult HIV patients on ARTs attending the HIV clinic at KATH
* Adult HIV patients with WHO stage IV and V AIDS
High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)

This research project intends to observe patients with high myopia who show pathological retinal changes, in order to evaluate more data on the risk factors for developing mCNV within this research project population in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Male or female caucasian patients ≥ 18 years of age
* Diagnosis of high myopia secondary to an anterior-posterior elongation of the bulbus confirmed by ocular examination in either eye using the following criteria:

  * Ocular ultrasonography or biometry demonstrating anterior-posterior elongation measurement ≥ 26 mm
  * abnormal change in retinal tissue by SD-OCT that are attributed to be caused by high myopia as shown in Table 4-2 of the protocol in the investigator's discretion confirmed by the reading centre

Exclusion Criteria:

* Patients with Diabetes mellitus of any grade
* Patients showing signs of Age-Related Macular Degeneration (AMD), e.g. drusen, characteristic changes in fundus (with shaping or extension of hemorrhages, fibrosis, exudative areas) in either eye
* Acute neovascularization (CNV or iris neovascularization) and intra- or subretinal fluid in either eye at the time of enrolment.
* History of inactive CNV in study eye. Inactive CNV of fellow eye is allowed if treatment was performed more than 12 months before enrolment.
* Any anti vascular endothelial growth factor' (anti-VEGF) or Verteporfin treatment in study eye and anti-VEGF or Verteporfin treatment less than 12 months before enrolment in fellow eye
* History of systemic anti vascular endothelial growth factor' (anti-VEGF) therapy
* Cataract that would prevent an accurate measurement of the axial length of the study eye

Other protocol-defined inclusion/exclusion criteria may apply
The Effects of Gabapentin Premedication on Neurosurgery

The study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or placebo orally the night before operation day and 2hours before surgery,respectively.The investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be observed in GG than GP.

This is a random, double-blind study. In GG, patients are given gabapentin 600mg orally at the night and 2hours before surgery, respectively. In PG, vitamine pills are given instead.Total intravenous anesthesia is applied for all patients. 1hour, 2hours,1day, 2days, 3months and 6months after surgery, patients are evaluated for pain (VAS) and incidence of PONV. In addition,Glasgow Score, Ramsay Score and other gabapentin-related effects, such as somnolence,dizzy or dry mouth are also observed.The incidence of persistent pain and neuropathic pain was assessed at the 3-mo and 6-mo postoperative evaluation.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old, ASA physical status I or II, BMI\<30
* Scheduled for elective craniotomy
* Cooperative and given informed consent in person

Exclusion Criteria:

* History of mental or psychiatric disorders
* Pregnant or lactating female
* History of systemic malignant tumor or diabetes
* Previously treated with this protocol or participated in another experimental study within previous 30 days
* Suspected history of allergic reaction or intolerance to gabapentin or other anesthetic agents in this study
* History of alcohol abuse and/or drug abuse within previous one year
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.

This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists.
* Life expectancy of at least 3 months
* Adequate hematological parameters
* No major impairment of renal and hepatic function

Exclusion Criteria:

* Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption.
* Patients who have received any investigational compound within the past 28 days.
* Patients with other antineoplastic therapy within the last 28 days.
* Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection
* Patients with a history of allergies to the camptothecin family drug.

Other protocol-defined inclusion/exclusion criteria may apply
Effectiveness of Physical Therapy Treatments of Myofascial Trigger Points in Subjects With Neck Pain

Neck pain is a prevalent musculoskeletal dysfunction. Studies point that individuals with chronic pain have metabolic, vascular and electromyographic changes in trapezius muscle. Moreover, a common clinical sign in this muscle in subjects with neck pain is the presence of myofascial trigger points. These are related to the sensory, motor and autonomic changes, being defined as palpable nodules located in the taut band of skeletal muscle. In this context, the focus on treatment modalities stands out in the literature, however, other resources commonly used in clinical practice still lack scientific evidence. Therefore, the aim of this project is to evaluate the effectiveness of physiotherapy resources in the treatment of myofascial trigger points in the trapezius muscle of patients with neck pain. For such, volunteers with neck pain for more than 90 days, of both genders, aged between 18 and 59 years and bilateral myofascial trigger points in the upper trapezius will be randomized into the following groups: group 1 (kinesiotherapy, n = 20), group 2 (kinesiotherapy + static ultrasound, n = 20), group 3 (kinesiotherapy + diadynamic currents, n = 20) and group 4 (untreated control, n = 20). Volunteers will undergo ten sessions of treatment, being realized the following evaluations: surface electromyography, infrared thermography, numerical scale of pain assessment, algometry, Neck Disability Index and skin impedance. For data analysis, normality test will used to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and thus considered two factors in the comparisons, time and group. Will adopt a significance level of 5%.


Eligibility Criteria:
Inclusion Criteria:

* neck pain for more than 90 days
* aged 18 to 59 years
* presence of trigger points in the upper trapezius muscle

Exclusion Criteria:

* history of trauma to the neck
* surgery in the head, face or neck
* herniated cervical
* degenerative diseases of the spine
* systemic diseases
* underwent physical therapy in the last three months
* analgesics, anti-inflammatories or muscle relaxants last week
* medical diagnosis of fibromyalgia
* body mass index (BMI) greater than 28 kg/m2
* signs and symptoms of depression
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy

The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.

In this study, 100 patients with carotid artery stenosis receiving carotid endarterectomy are included in our center in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years, \<80 years, regardless of sex;
2. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 50% (Based on North American Symptomatic Carotid Endarterectomy Trial Collaborators (NASCET) Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
3. Baseline mRS 0-2;
4. Can cooperate with and complete brain magnetic resonance imaging (MRI) examination;
5. Signed and dated informed consent is obtained;

Exclusion Criteria:

1. Evolving stroke;
2. Chronic complete occlusion of the carotid artery without obvious symptoms of cerebral ischemia;
3. Severe dementia;
4. The causes of cardiogenic embolism, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombosis or valve tumor, congestive heart failure, bacterial endocarditis, etc;
5. Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment);
6. Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine \>265umol/l (3mg/dl));
7. The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
8. Pregnant or lactating women;
9. He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
10. Other conditions that the researchers think are not suitable for the group.
A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain

This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain .

The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles.

The 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles.

The 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles.

The 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug .

At the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers.

Then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .


Eligibility Criteria:
Inclusion Criteria:

* patient with myofascial trigger points in masseter or temporalis previously ----\*identified by manual palpation.

  * 18 years or More "Willingness to follow instructions.

Exclusion Criteria:

* therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint.

  * Clinical conditions as pregnancy
  * Medical problems that will interfere with the procedure as bleeding disorders.
  * Cognitive impairment or present inadequate cooperation.
PET-CT to Assess Brain Damage in Cardiac Arrest Patients

This was a single-center, observational study. Patients with successful cardiopulmonary resuscitation (CPR) will be transferred to the emergency intensive care unit for further standardized management. After successful return of spontaneous circulation (ROSC) for 72 hours and hemodynamic stability for 24 hours, the patients underwent positron emission computed tomography (PET-CT) examination after resuscitation. The supervising physician accompanied the patient and used monitors to monitor vital signs during the examination. Patients who were on ventilators were mechanically ventilated with a magnetic ventilator (HAMILTON-MRI, United States). In addition to conventional cerebral oxygen metabolism, cerebral blood flow, oxygen extraction fraction, cerebral blood volume and other indicators were added in this experiment. These indicators can evaluate the patient's cerebral metabolism, cerebral blood flow and cerebral blood oxygen damage degree. The neurological outcome was followed up 6 months after onset according to the cerebral performance category（CPC）.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years.
* sustained hemodynamic stability for ≥24h.
* the patients were unconscious and not able to obey verbal commands. • Advanced life support and target temperature management within 6 hours of return of spontaneous circulation (ROSC).

Exclusion Criteria:

* Patients with hemodynamic instability.
* Patients who could not complete cranial PET-CT examination for special reasons. • Patients during pregnancy.
* Patients who combined traumatic brain injury, stroke, cerebral hemorrhage and other diseases.
* Patients whose family members did not agree to be enrolled.
Comparative Effects of Intensive and Distributed CIMT on Upper Extremity Function in Stroke Patients

The main question this clinical trial is aims to answer is whether intensive and distributed constraint-induced movement therapy has similar effects on upper extremity function in participants with stroke. Participants will receive intensive protocol of CIMT for 6 hours for 6 days to make total of 36 hours while distributed protocol participants will receive 2.25 hours of training two times a week for 8 weeks making total of 36 hours.

Many studies have examined the effects of constraint-induced movement therapy (CIMT) in upper extremity function in stroke patients. Literature has shown effectiveness of different CIMT protocols for stroke patients. Emerging research have demonstrated comparative efficacy of constraint-induced movement therapy with different physical therapy approaches i.e. bimanual intensive training, motor relearning programme for improving upper extremity function. But according to researcher's knowledge, the gap of current knowledge is that no study has directly investigated the comparative effectiveness of intensive and distributed CIMT in stroke patients and if intensive and distributed CIMT had similar motor outcomes in upper limb function after stroke

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* ischemic or hemorrhagic stroke
* Both genders eligible
* Gcs score ≥ 13
* Able to extend at least 10° at the fingers
* Able to extend at least 20° at the wrist
* Patients diagnosed with one side more affected(hemiplegia)
* Modified Ashworth scale score ≤2

Exclusion Criteria:

* severe, chronic systemic illness
* Epilepsy
* History of fall past 6 months
* Injections of botulinum toxin type A or operations on the UE within 6 months
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects

An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a randomized, open-label, crossover study in which they will receive Sporanox® to compare the safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.

For the renal and hepatic subjects, following the screening visit, eligible subjects will return to the study site on Study Day 0 and remain at the site for 2 nights and 2 days. Study drug administration will occur on Study Day 1. Subjects will be discharged on Study Day 2 after the last blood sample has been collected. Subjects will return 7 ± 3 days after dosing with study drug to have final safety assessments performed. For the healthy subjects, following the screening visit, eligible subjects will return to the study site on Study Day 0 and remain at the site for 3 nights and 3 days. Study drug administration will occur on Study Day 1 and Study Day 2. Subjects will be discharged on Study Day 3 after the last blood sample has been collected. Subjects will return 7 ± 3 days after receiving the last dose of study drug to have final safety assessments performed.

Eligibility Criteria:
Inclusion Criteria (General):

* The subjects must be males or females and ≥ 18 years of age and ≤ 65 years.
* The subject must be willing and able to provide signed informed consent.
* The subject must be willing and able to stay at the clinical site for the required number of days and nights and return to the clinic in 7 ± 3 days after dosing with study drug.

Inclusion Criteria (subjects with mild or moderate chronic renal insufficiency):

* The subject must have mild or moderate chronic renal insufficiency and documented history of stable renal disease for 1 month prior to screening and clinical laboratory test results consistent with the underlying disease for renal impairment.

Inclusion Criteria (subjects with mild chronic hepatic impairment):

* The subject must have mild chronic hepatic impairment, as defined by Child-Pugh Classification A, Score of 5-6 and a bilirubin of ≤ 2.5 mg/dl.

Inclusion Criteria (for healthy subjects):

* Healthy subjects will be matched to renally impaired subjects in this study by age (+ 10 years), gender, and body weight (± 10 kg).

Exclusion Criteria:

* The subject has a known allergy or hypersensitivity to diclofenac, other NSAIDs, any of the excipients of the study preparation (hydroxypropyl-ß-cyclodextrin (HPßCD), monothioglycerol, sodium hydroxide, hydrochloric acid, and water for injection), itraconzaole or other "azole" drugs, or to any of the excipients in Sporanox (HPßCD, propylene glycol, sodium hydroxide, hydrochloric acid, or water for injection).
Measuring Blood Pressure in the Lung Circulation With Sonar Technology (Echo-Doppler)

This is a non-invasive study using a standard doppler echocardiographic transducer which records signals emanating from the lungs (TPD). These signals are caused by pulsation of blood vessels in the lung tissue.

The innovations in this study are:

1. The software processing of the reflected ultra-sound waves from the lung rendering a reproducible, clear and strong signal in sync with the cardiac cycle,
2. The observation based on pilot studies that blowing hard against resistance during recording (something called a Valsalva maneuver), affects the lung signal weakening it and even obliterating it as the pressure rises.

The investigators hypothesis is that since the signal comes from the blood vessels in the lung, the pressure at which the recorded signal disappears during the Valsalva maneuver represents the blood pressure in the lungs.

Current methods for noninvasive measurement of pulmonary arterial blood pressure by standard echo-doppler equipment are fraught with uncertainty. So much so that patients being screened and followed for pulmonary arterial hypertension require right heart catheterization. An invasive and uncomfortable and potentially dangerous procedure.

This study is designed to confirm our preliminary observation that there is good correlation between Valsalva maneuver pressure and pulmonary arterial blood pressure.

Sixty patients undergoing right heart catheterization for clinical reasons will be studied.

The study itself is short, about 30 minutes, painless and done with the patient either sitting up in bed or semi-reclining. The probe is positioned over the right chest wall and the patient is requested to successively blow into a mouthpiece at rising pressures, to tolerance.

The results obtained using TPD to asses pulmonary arterial pressure will be compared to the results obtained at catheterization.

This is part of the development phase of the technology.

Eligibility Criteria:
Inclusion Criteria:

Eligibility

* Age 18 years or older
* Patients who are clinically suspected of having elevated pulmonary blood pressure , due to cardiac or cardio-pulmonary disease preferably any one or more of the conditions listed below, and due to have right heart catheterization as part of the diagnostic work-up:
* Patients with CHF
* Patients with primary pulmonary arterial hypertension
* Patients with COPD
* Patients with asthma
* Patients with interstitial lung disease
* Patients with sarcoidosis
* Signed informed consent.

Exclusion Criteria:

* Patients unable to cooperate.
* Inability to assume a sitting or supine position
* Patients with severe chest wall deformity