cyrilzakka/clinical-trials huggingface dataset:
Important Data on COVID-19 Profile in Africa

The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples.

In this study ,the participants will be enrolled sequentially in the COVID-19 care referral centers. The infected hospitalized patient will be identified by the physicians in hospital. After the patient has given his/her informed consent the permission will be sought from him to approach his household contacts. The household contacts will be screened, and included in the study.

Patients hospitalized and positive for COVID-19 by PCR and their household contacts of all ages and gender (40% minimum of female), will be enrolled upon receipt of written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Molecular (PCR) confirmed COVID-19 patients hospitalized in referral centers,
* Household contacts of hospitalized COVID-19 patient,
* Provided signed informed consent.

Exclusion Criteria:

* Pregnancy
Physiological, Behavioural and Subjective Measures of Listening Effort

Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) listening to short radio excerpts and answering subsequent comprehension questions. At the same time participants are required to perform a manual target-tracking task on a touch screen. During this study, continuous, non-invasive physiological measurements (heart rate, skin conductance and hemoencephalography) will be made from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a three factor (listening task x algorithm x signal-to-noise ratio), within-subjects design. Each participant performs each listening task (about 4min long each) with each algorithm (reference, noise reduction I, noise reduction II), at two signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).


Eligibility Criteria:
Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature
* Minimum 1 year hearing aid experience
* Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of homeopathy for insomnia.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to begin chemotherapy or radiotherapy
* chemotherapy or radiotherapy
* meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
* Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
* have the permission of their oncologists to participate.

Exclusion Criteria:

* untreated alcohol or substance abuse or dependence,
* bipolar, or psychotic disordermedical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
* untreated sleep disorders such as sleep apnea
* Taking other alternative medicines
A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets (80 mg/day) in MS patients with spasticity. Arbaclofen ER will be compared with placebo. The treatment groups will be randomized in a 1:1 ratio. There will be a 49-day dose escalation period, followed by a 84-day maintenance treatment period, followed by a 21-day taper period.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 to 65 years of age, inclusive
* An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR or SP course) that manifests a documented history of spasticity for at least 6 months prior to screening
* Spasticity due to MS as shown by a TNmAS-MAL score ≥ 2
* Expanded Disability Status Scale (EDSS) score greater than or equal to (≥) 3.0 and less than or equal to (≤) 7.0
* Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement
* Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects)
* Willing to sign the informed consent form (ICF)

Exclusion Criteria:

* Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
* In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
* Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
* Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit
* Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
* Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma
* Any other significant disease, disorder, or significant laboratory finding which, in the opinion of the investigator, puts the subject at risk because of participation, influences the result of the study, or affects the subject's ability to participate
Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

The frequency of auto-immune diseases (including multiple sclerosis) is increasing in industrialised countries.

According to an hypothesis which is receiving a wide international credit, this may be due to the fact that the populations of these countries are increasingly less exposed to microbes further to the improvement of hygienic conditions and to the use of antibiotics.

If exposure to microbes is lacking, also their regulatory function is missed with a consequent possible onset of auto-immune symptoms.

For this reason, it is deemed that by exposing the immune system of a patient to an ancient microbe, being complex and important in man evolution, like the Tuberculosis Mycobacterium, it is possible to rebalance the immune system.

Vaccination with the Tuberculosis Mycobacterium has proved to be effective in the animal model of multiple sclerosis, experimental allergic encephalitis.

In a study of phase I-II our group has demonstrated the safety of this therapy together with preliminary evidence.

The study includes patients with an initial disease (diagnosis supported by paraclinical criteria): single clinical poly or mono-symptomatic attack in the 6 months preceding the study, MR picture compatible with MS.

Study design 100 randomized patients (i.e. randomly assigned) to be included either in a group of 50 patients undergoing therapy or to a group of 50 patients receiving placebo.

Patients are followed up with monthly contrast MRI for 6 months. At the end of the six months the disease activity in the group of treated patients is benchmarked with the disease activity of the group of patients receiving placebo.

Safety is granted by the extremely wide diffusion of this kind of vaccination worldwide and by the previous study in patients affected by multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an initial disease (diagnosis supported by paraclinical criteria): single clinical poly or mono-symptomatic attack in the 6 months preceding the study, MR picture compatible with MS

Exclusion Criteria:

* Therapy with corticosteroids in the last month
* Plasmapheresis, administration of gamma globulins in the last three months
* Serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams
* Evidence of infections
* Evidence of tubercular disease
Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB

This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.


Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 18 years old suspected of TB clinically.
2. Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced.
3. BAL samples obtained following standard investigation procedure
4. CXR or CT imaging available.

Exclusion Criteria:

1. Bronchoscopy is not planned as a necessary procedure for investigation.
2. Diagnosis of active TB has been made by other means.
Study On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis

Metformin is the first line drug of choice for the treatment of type II diabetes. Lactic acidosis can develop as a side effect, especially when renal failure leads to drug accumulation. Lactic acidosis is usually attributed to an abnormal inhibition of hepatic lactate clearance.

Growing evidence suggest that metformin can dose-dependently inhibit hepatocyte mitochondrial function. Whether a similar effect occurs in extra-hepatic human tissues remains unknown.

The investigators hypothesize that mitochondrial dysfunction occurs during metformin intoxication even in tissues other than the liver, thus contributing to the development of lactic acidosis. The aim of this study is to investigate mitochondrial integrity in circulating platelets of patients with lactic acidosis due to metformin intoxication.


Eligibility Criteria:
Inclusion Criteria:

1. Lactic acidosis (pH \< 7.35 or base deficit \> 5 mmol/L and lactate \> 5 mmol/L)
2. Metformin intoxication (serum drug level \> 4 mcg/mL)
3. Absence of evidence of any other condition that could primarily explain the lactic acidosis

Exclusion Criteria:

1. Less than 18 years of age
2. Hemoglobin \< 8 g/dL (10 g/dL if ischemic cardiac disease)
The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness

Objectives:

To determine the association between priming and measurements of hand function such as grip strength

Primary null hypothesis:

There is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to patients that complete the positively adjusted PCS.

Secondary null hypotheses:

There is no difference in grip strength (last of three attempts) as a percent of the opposite hand between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.

There is no difference in grip strength (best of three attempts) before and after completing the questionnaires between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.

Priming affects all aspects of human behavior. Prior research by the investigators' group determined that completing a positively phrased version of the pain catastrophizing scale (PCS) primed patients to report less disability on average than completing the standard PCS. The influence of priming can be better understood by determining if it also affects direct measurements of hand function such as grip strength measures.

Eligibility Criteria:
Inclusion Criteria:

* All English-speaking adult patients visiting the Orthopaedic Hand and Upper Extremity Service

Exclusion Criteria:

* Unable to complete enrollment forms due to mental status or language problem
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection

The FRDTM is easy to perform and does not require sophisticated laboratory technology and/or experienced pathologists for test result interpretation. Compared to the Pap smear and HPV test, the FRDTM enables clinicians to obtain test results immediately (within 60 seconds) after the screening. This empowers clinicians in making timely decisions on appropriate patient management, and facilitating patient compliance with follow-up procedures. In addition, the FRDTM requires minimal training and technical support. Due to its advantage of rapid visualization of abnormal cervical lesions (CIN2+) in a cost-effective way, health care professionals can make cervical cancer detection accessible to women worldwide, especially in regions with limited medical resources. This is a cross-sectional study to evaluate the clinical performance of Folate Receptor-Mediated Epithelium Staining (FRDTM) in detecting cervical neoplastic lesions (CIN2+).

The Folate Receptor-Mediated Staining Solution is a dye solution that stains for medical purposes used in staining cells and tissues for detecting neoplastic diseases. The main purpose of this product is to detect abnormal cervical lesions (CIN2+) during a gynecological speculum examination. Therefore, the purpose of this study is to evaluate the clinical performance of Folate Receptor-Mediated Epithelium Staining (FRDTM) in detecting cervical neoplastic lesions (CIN2+).

The subjects who are enrolled in this study will first undergo the FRD test, then cytology and HPV test. Women with abnormal cytology (≥ ASCUS/AGC), positive FRD test in either the cervix or cervical canal, and/or positive HPV test will be referred to colposcopy. In addition, 10% of the subjects who tested negative for all three tests and are ≥ 25 years old will be randomly selected to complete a colposcopy as well.

According to the colposcopy assessment, if the results show satisfied (type I) then a biopsy will be taken. Subjects with a positive FRD test for the cervical canal, unsatisfied colposcopy (type II-III), and/or detection of AGC during cytology will have to complete an ECC procedure as well. Finally, a histopathological examination will be done and used as the gold standard. Subjects with a histopathological examination result of \< CIN2 will be asked to come back for a follow up visit within 6 months or 1 year, according to the investigator's discretion. Subjects can exit the study at any time after colposcopy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Patients who need to do gynecological pelvic examination
* Age and sex: Women between the ages of 20 - 65

Exclusion Criteria:

* Women with total hysterectomy
* Women who have done cervical surgeries, including physiotherapy of conization, LEEP, infrared ray, and microarray
* Women with serious cervical contact bleeding
* Women who are pregnant or menstrual period before the examination
* Women with acute inflammation of cervix and/or vagina
* Women who were already diagnosed with CIN2+
* Women who are taking an oral and/or injection of anti-cancer drugs
Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC

Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions.

Primary endpoint is the local disease control in the chest.

Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions.

Primary endpoint is the local disease control in the chest

Eligibility Criteria:
Inclusion Criteria:

* histologically proved NSCLC
* UICC-stage I-III, no resection planned
* complete staging \< 6 wks before treatment including cranial CT
* ECOG \<3, Karnofsky-Index \>60%
* age \> 18 \<
* FEV1 \> 1,0 l or \>35%
* RT-planning according to protocol feasible
* chemotherapy feasible
* written informed consent

Exclusion Criteria:

* neuroendocrine tumors, plain broncho-alveolar-cell ca.
* distant metastases, supraclavicular lymph node metastases
* malignant pleural effusion
* resection of actual tumor performed
* inclusion in other study protocol
* chemotherapy due to actual tumor before FDG-PET
* induction-chemotherapy
* acute vena cava superior syndrome
* second malignancy other than basalioma
* pregnancy, lactation
* heart insufficiency NYHA III/IV
* pneumoconiosis with active inflammatory changes of mediastinal lymph nodes
* acute broncho-pulmonary infection at time of PET-examination
Do Markers of Systemic Inflammatory Response and Tumor Metabolism Indicate Radioresistance in Head and Neck Cancer?

The aim of the study is to prospectively evaluate whether markers of a patient's systemic inflammatory response in addition to FDG-PET/CT metabolic parameters of the primary tumor or of nodal metastases can predict radioresistance and survival before primary radiochemotherapy in advanced head and neck cancer patients.

This study prospectively investigates pretherapeutic markers of systemic inflammatory response (including neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, lymphocyte-to-monocyte ratio, systemic inflammation response index, and systemic immune-inflammation) and FDG-PET/CT-derived metabolic parameters of tumor and nodal metastases (including maximum standardized uptake value, metabolic tumor volume, and total lesion glycolysis) and their potential prognostic value in head and neck cancer patients prior to primary radiochemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* histopathologic diagnosis of squamous cell carcinoma of the head and neck
* primary radio(chemo)therapy with curative intent
* available pretherapeutic FDG-PET/CT imaging
* available pretherapeutic differential blood analysis

Exclusion Criteria:

* other tumor entities of the head and neck including cutaneous squamous cell carcinoma
* primary surgical treatment
* ongoing infections or other inflammatory diseases at the time of diagnosis
* patients not completing a course of irradiation with at least 66 Gray locally
IV Cocaine Abuse: A Laboratory Model - 1

The purpose of this study is to evaluate the effects of desipramine DMI maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.


Eligibility Criteria:
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Effect of a Vegetarian Meal on the Physiology of Insulin Response in Patients With Type 2 Diabetes Mellitus and Obesity

The role of diet in determining glucose intolerance and its progression towards T2DM has been extensively investigated. A 2017 meta-analysis showed that a vegetarian diet is inversely associated with the risk of developing diabetes. Vegetarians, with the same baseline risk, are half as likely to develop T2DM than those following an omnivorous diet. Therefore, vegetarian nutrition could have important clinical implications in the dietary management of diabetic patients.

The primary objective of the study is to evaluate the effect of two different isocaloric meals, one vegetarian compared to a conventional Mediterranean-type one (vegetable protein source in the first case and animal in the second case), eaten at lunch, 1÷3 weeks apart, on the pathophysiology of glucose and insulin response. The two meals were elaborated in such a way as to have a superimposable composition.

Study population: 20 patients diagnosed with T2DM and BMI ≥ 30, belonging to the Diabetes and Clinical Nutrition clinic of the IRCCS San Raffaele Hospital.

Study design: single-center, interventional, controlled, randomized crossover.

Procedures: the patients enrolled in the study, for each of the two meals, underwent serial blood tests, before eating lunch (T0) and every 30 minutes, up to 3 hours after the end of the meal itself (T2÷T6).

Collected variables: blood sugar, insulin, c-peptide, HbA1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, height, weight, waist circumference and blood pressure, visual analogue scale (0-10) for sense of hunger and satiety , meal satisfaction index (0-10).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Diagnosis of T2DM
* In treatment with diet alone or single oral drug metformin
* BMI ≥ 30
* HbA1c between 6.0 and 9.0% (42-75 mmol/mol)
* Signature of the informed consent

Exclusion Criteria:

* History of acute/chronic pancreatitis
* Pancreatic cancer
* Pancreatic surgery
* Renal failure (any stage)
* Liver cirrhosis
* Thyroid disorders (hypothyroidism, hyperthyroidism)
* Patients with weight loss in the last 3 months equal to or greater than 5% of body weight
* Patients on therapy other than metformin monotherapy (insulin, glucagon-like peptide agonists, sulphonylureas, glitazones, dipeptidyl peptidase inhibitors, SGLT2 inhibitors).
* Pregnant or breastfeeding women
* History of severe allergic reaction to any food (anaphylaxis)