cyrilzakka/clinical-trials huggingface dataset:
A Trial of Isoniazid for the Reversion of Interferon Gamma ELISPOT in Tuberculosis (TB) Case Contacts

There are new TB vaccines already developed that need to be tried in humans to assess their efficacy.

The researchers had previously shown that production of interferon gamma by T cells in response to TB antigens is a more specific marker of TB infection.

The researchers hypothesize that this can be used as a reliable early marker of TB vaccine efficacy. The researchers expect to show a significantly increased reversion of this test in household contacts of TB patients given Isoniazid prophylaxis treatment for 6 months.

Current efforts to control the spread of tuberculosis are failing. An increasingly large number of new generation vaccines are being produced and a plan for assessing their ability to prevent disease and treat infection needs to be developed.

The MRC Labs in The Gambia is well positioned to conduct safety and immunogenicity studies and also to conduct trials of the therapeutic effect of these vaccines in preventing disease in case contacts who are infected.

This study is part one of a three-step plan to develop a reliable early surrogate marker of the therapeutic efficacy of new TB vaccines.

The three-step plan is as follows:

* Evaluate the ability of isoniazid, known to be effective in the treatment of MTB infection, to revert the antigen-specific IFNg-ELISPOT in ESAT-6 and/or CFP-10 positive contacts of TB patients.
* Compare the ability of different combinations of a TB vaccine and isoniazid to revert the ELISPOT in a 4-arm randomised trial using:1) isoniazid alone, 2) a TB vaccine alone, 3) a combination of isoniazid and TB vaccine, and 4) placebo
* Compare, in a randomized trial, the ability of TB vaccine or vaccine plus isoniazid versus isoniazid alone to prevent the development of secondary disease.

For this first step the researchers will test the following hypothesis:

* Those receiving isoniazid have a significantly higher reversion rate of MTB-specific responses as measured with IFNg-ELISPOT assays compared to those who receive a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy person aged 15 years and above
* Normal medical history and physical examination
* Normal biochemistry and haematological indices
* Mantoux ≥ 10mm
* Negative HIV antibody test
* No serological evidence of hepatitis B virus (HBV) infection
* Normal Chest X-ray
* ESAT6 and/or CFP-10 peptides and ESAT6/CFP-10 protein positive (≥10 SFC for ESAT 6 or CFP-10 and ESAT6/CFP-10 protein).
* Index case is sputum smear positive
* Index case has chest X ray (CXR) characteristics of TB

Exclusion Criteria:

* Pregnant female
* Haemoglobin \<8 g/dl
* Previous history of tuberculosis
* Clinical case of tuberculosis
* Current participation in another clinical trial, or within 12 weeks of this study.
* Any other factor that might increase the risk of an adverse outcome from participation in the trial
* Significant history or evidence of skin disorder, allergy, immunodeficiency, organ specific disorders causing significant immunodeficiency.
Point-of-care-ultrasound in Swiss Air Rescue Rega

The aim of the study is, on the one hand, to objectively investigate the patient-oriented benefits of prehospital point-of-care ultrasound (POCUS) examinations under the conditions of the helicopter emergency medical services (HEMS) in Switzerland. On the other hand, the study will show what the diagnostic quality of prehospital POCUS examinations is and how emergency medical teams can be trained to use POCUS in the future.

HEMS crew members will answer a short online questionaire about how findings of their POCUS examination has influenced their medical treatment, diagnosis and selection of target hospital for the patient (primary outcome parameters).

In addition, a study nurse will query the findings of the in-hospital diagnostic tests and compare them with the findings of the pre-hospital POCUS examination. This will enable the investigators to evaluate the diagnostic quality of the prehospital POCUS examination and to identify which findings are often not recognised in the POCUS. The subjective satisfaction and assessment of the benefit of the POCUS examination by the respective users will also be recorded (secondary outcome parameters).


Eligibility Criteria:
Inclusion Criteria:

* All patients in whom the treating Rega team uses POCUS pre-hospital
* existing written General Consent (with permission to use patient data for research)

Exclusion Criteria:

* Age \&lt;18 years
Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

In general, central sleep apnea is not as common as obstructive sleep apnea but it is common in patients with heart failure. It has been repeatedly shown that central sleep apnea worsens the prognosis of heart failure. The current concept in the development of CSA is hypocapnia which causes temporary cessation of respiratory neural output. Different methods for supplement of CO2 have been used to eliminate CSA. However, variation of CO2 concentration during overnight treatment and tight-fitting mask made the treatment uncomfortable. It is important to develop a device with a comfortable mask to supply constant low dose CO2 without breathing difficulty. We recently developed a device for treatment of CSA.

Objective: To determine whether the device could improve sleep quality while eliminating CSA during the overnight study. Methods: Patients with central sleep apnea diagnosed by diaphragm EMG will be recruited in this study. CO2 concentration for treatment would be manually titrated during overnight PSG. Patients were then treated with an effective lowest concentration of CO2 derived from titration under PSG on the third night. The sleep apnea hypopnea index (AHI), central sleep apnea index (CHI), arousal index (ArI), Oxygen desaturation index (ODI), sleep structure, blood pressure, heart rate, diaphragm EMG, treatment side effects and treatment preference were to be observed.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to participate after informed consent
2. Males and females, any race and aged≥18yeras
3. Objectively confirmed central sleep apnea/Cheyne Stokes Respiration with an apnoea-hypopnoea- index (AHI)≥5/h by overnight polysomnography

Exclusion Criteria:

1. Obstructive sleep apnea
2. Severe COPD，FEV1/FVC\<70% and FEV1\<60%
3. Chronic CO2 retention with unknown reason
4. Severe nasal congestion
5. Poor understanding
Neurostimulation in Chronic and Episodic Migraine

Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic) drug therapy. In contrast, neurophysiologically guided treatments might provide an alternative avenue, since these can normalize brain alterations without side effects. Transcranial direct current stimulation (tDCS) appears useful in the acute and prophylactic treatment of migraine, probably because of its modifying and re-balancing influence on neuronal activity. Yet, to test for the efficacy of tDCS in a clinically acceptable way, it is necessary to apply not only tDCS but also a "sham" placebo, which is often neglected in tDCS stimulation studies. Further, tDCS needs to be applied in a large (n \> 20) sample of well-defined migraine patients, which would be advantageous, compared to previously published work. Monitoring sources of regional neuronal alterations in migraineurs prior and after tDCS is essential to investigate physiological mechanisms of tDCS. There is an increasing interest towards non-pharmacological treatment alternatives for migraine (and headache disorders) with reduced side effects to established prophylactic medications. The primary outcome of this project is to demonstrate that repetitive sessions of neurostimulation lead to a significant and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients suffering from chronic and episodic migraine. Since neurostimulation tools are nowadays accepted as therapeutic tools, our study might provide evidence that tDCS can be a non-pharmacological alternative for treating migraine.


Eligibility Criteria:
Inclusion Criteria:

Patients from age 18 upwards (max. 80 years) suffering from chronic or episodic migraine. Medication overuse headache (MOH) patients are included as well (as chronic migraine patients do often show MOH).

Healthy volunteers (18-80 years) are included if they don't fulfil the exclusion criteria and do not suffer from migraine or other headache disorders, except infrequent episodic tension-type headache All volunteers are able to read and sign the informed consent.

Exclusion Criteria:

Patients and healthy volunteers are excluded if they fulfil one of the following exclusion criteria:

Common MR exclusion criteria: such as metallic items in the body (i.e. eye splinter, MR incompatible implants\*), pacemaker, claustrophobia or obesity (body mass index \> 35).

Also pregnant participants and participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease will be excluded. Participants with major psychiatric disorders such as schizophrenia, bipolar disorder will also be excluded.
Survey of Patients Taking IOP-Lowering Eye Drops

Survey to assess perspectives of patients prescribed IOP-lowering eye drops at a single office visit.


Eligibility Criteria:
Inclusion Criteria:

* Prescribed IOP-lowering eye drops

Exclusion Criteria:

* Can complete survey instrument in English
Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)

The experimental focus of this project is on the interaction of DHEA treatment on pregnancy in women with open tubes, fertile male partners and evidence of premature ovarian failure.

Recruitment:

* New patients presenting for Donor egg cycles
* Possible print, magazine or Radio advertisement

Experimental plan:

1. Informed consent
2. Baseline studies

   * Antral follicle counts
   * Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
3. Randomization

   * Group A: DHEA (25 mg three times per day)
   * Group B: Placebo
4. Monitoring during treatment

   * All participants will have:
   * USG for follicle measurement
   * Repeat serum, FSH, E2, DHEA, DHEAS, testosterone, AMH monthly during treatment.
   * Physical examination
   * Completion of study questionnaire regarding possible androgen effects of treatment
5. Analysis plan:

   * Primary Outcome
   * Pregnancy
   * Pregnancy rates will be compared using logistic regression with age and pre-treatment AMH as covariates.
   * Secondary Outcomes
   * Endocrine Factors
   * Androgen side effects
   * Primary analysis. We will perform a factorial ANOVA for the two pretreatment factors DHEA and Placebo. Baseline AMH and age as main covariates
   * Secondary analysis.
   * Examine rate of change of estradiol and other endocrine response over the four cycles of treatment
   * Compare antral follicle counts across cycles between groups
   * Compare possible androgen related effects
   * Power considerations:
   * Power assumptions: alpha 0.05; 80% power

Spontaneous Pregnancy rate for POF is less than 1% per 3 months Intervention will improve pregnancy rate to 10% per 3 months. Patients will be treated for 3 cycles. Require 100 patients to complete treatment in each group. Allow for 20% dropout will need 120 patients randomized to each group

* Randomization:

Randomization will be by permuted blocks in order to maintain an even distribution among the groups (because of the small numbers of participants)

* Human subjects issues
* Potential risks associated with DHEA use
* Potential risk of delay of treatment for 3 months and possible natural continued loss of fertility
* Informed consent issues

Eligibility Criteria:
Inclusion Criteria:

* \>= 1 year of infertility
* \>21 and \<40 years old
* Normal HSG
* Normal Semen analysis (Count \>= 20 million/ motility \> 50%/ Kruger morph \> 14%.
* Absent menses
* Willingness to sign informed consent for study randomization
* Willingness to participate in 3 months of treatment.

Exclusion Criteria:

* Abnormal semen analysis
* Abnormal HSG
* Medical condition that would contraindicate pregnancy, ovulation induction or general anesthesia
* Family history of significant genetic disease, or factor V leiden thrombophilia
* Inability to present for monitoring visits
* Inability to follow medication instruction
* Desire to undergo other fertility treatments before completing three months of this trial
Translation and Cultural Adaptation of the Groningen Frailty Indicator (GFI) in Patients With Hip Fracture

This study attempts to the translation and the cultural adaptation of the Groningen Frailty Indicator (GFI) questionnaire in the Greek population in patients suffering from hip fracture.

Frailty indicates a state of vulnerability in terms of poor health outcomes, such as mortality, hospitalization, institutionalization and loss of function in one or more domains (i.e. physical, psychological, cognitive and social domains). Frailty is not only associated with poor quality of life and life satisfaction but also has an effect on health care demands, as the number of frail people in our aging population will increase.

Current literature suggests that frailty is a common condition among elderly patients with hip fracture. Ageing has been associated with a decline in physiological reserves which impedes the body's ability to withstand and recover from minor and major challenges, such as the hip fracture. Hence, accurate diagnosis of frailty seems mandatory. The Groningen Frailty Indicator (GFI) questionnaire is a feasible, reliable and valid self-assessment tool.

This study will provide the first official Greek translation and cultural adaptation of the GFI according to the ISPOR (International Society for Pharmacoeconomics and Outcomes Research) guidelines.

Eligibility Criteria:
Inclusion Criteria:

* adult patients over 65 years old with hip fractures undergoing surgery
* an ASA (American Society of Anesthesiologists) PS (physical status) I to III
* non-institutionalized
* able to communicate orally or in writing
* consent to participate

Exclusion Criteria:

* refused to participate
* pathological hip fractures
* institutionalized
* patients with hip fracture treated conservatively
* patients with severe cognitive dysfunction
* patients with insufficient knowledge of the Greek language
Genetic and Blood Biomarkers in Neurological and Neuromuscular Diseases

The purpose of this study is to identify genetic or other factors in the subjects blood that may predispose them to getting a particular disease or tell researchers how the disease will behave, for example how fast it will progress or what areas of the body might be affected. A second goal is to relate such factors to how such a condition affects the subjects clinically as well as how it affects the electrical functions of nerves and muscles.

The etiology of many neurological and neuromuscular disorders is largely unknown. Contributions likely come from both inherited and environmental factors. Amyotrophic lateral sclerosis ("ALS") is a prototypical example. In 5-10% of cases, genetic mutations exert a strong enough influence on disease development that the syndrome is transmitted in a clearly Mendelian fashion. Investigations in these "familial" ALS cases have identified more than 20 causative disease genes. Intensive study of these genes has helped identify several key cellular pathways as important for disease, not only in cases with obvious gene mutations, but even in the 90% of ALS cases that appear to be "sporadic." Further insights have come from investigating blood biomarkers in ALS such as gene and protein expression and lymphocyte profiling. It is hoped that further genetic and biomarker analysis will identify additional genetic risk factors or biomarkers to better understand the disease and improve therapeutic development. These advances can be applied not just to ALS but to the broad range of neurological and neuromuscular diseases, including Charcot Marie Tooth neuropathy, the muscular dystrophies, epilepsies, Parkinson's disease, and Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be individuals with neurologic or neuromuscular disease who are deemed well-enough for sample collection.

Exclusion Criteria:

* Subjects who are not willing to undergo sample collection, genetic analysis, or unwilling to share clinical information or their samples.
* Pregnant women will also be excluded.
Macintosh Laryngoscope Assisted Fiberoptic Intubation

During fiberoptic endotracheal intubation, the perfect airway exposure produced by the classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver may increase the accuracy and produce rapid direct vocal cord access in a short time under Inhalation anesthesia to maintain the respiratory drive for grade III\&VI Modified Mallampati .

Managing difficult airway is critical for anesthesia-related morbidity and mortality. Fiberoptic laryngoscope is a reliable tool for endotracheal intubation in difficult airway cases (Modified Mallampatti III\&IV), but always there is difficulty to visualize the glottis due to airway tendency to collapse, classically a specific fiberoptic airway with a side way is used and it may added head tilt chin lift jaw thrust. A new technique utilizing sevoflurane anesthesia to maintain the respiratory drive without exposing the patient to the stress of the awake airway instrumentation. Simultaneous utilization of both Macintosh curved laryngoscope and Fiberoptic bronchoscope during Endotracheal intubation (ETT) will be examined for the efficacy during difficult airway management.

All patients should be examined preoperatively for the scoring Modified Mallampati or non tongue protrusion mallampati (NT-MMT) airway score. The pharyngeal structures were then evaluated and the best view (lowest class) was recorded. The classification follows m-MMT and is as follows: class 1, full visibility of tonsils, uvula, and soft palate; class 2, visibility of hard and soft palate, upper portion of tonsils and uvula; class 3, visibility of the soft and hard palate and base of the uvula; and class 4, visibility of only the hard palate, class III or IV patients were included in the study. Inhalational anesthesia use maintains the respiratory drive of the patient allowing less stressful technique.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Modified Mallampati (NT-MMT) airway score III,VI
* American Society of Anaesthesiologists (ASA) physical class I-III
* Scheduled for elective cancer surgery under general anesthesia

Exclusion Criteria:

* Modified Mallampati I,II Airway scored patients.
* History of upper airway surgery.
* Patients with serious deformities of the mandible, maxilla, tongue, pharynx or larynx.
* Patients with a history of significant cardiac and pulmonary diseases,
* Obesity with BMI \>40,
* Epilepsy, pregnancy, mental disease, neurological psychological disorders.
* Communication barrier.
Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids

Patients with three lesions of alopecia areata are randomly recruited in this study. Each lesion is randomized in to receiving either carboxytherapy in one lesion, intralesional steroids in another lesion and combination of both in the third lesion.

Treatment period is 3 months followed by a follow-up period of 2 months.


Eligibility Criteria:
Inclusion Criteria:

* early localized scalp alopecia areata
* patients who did not receive any medication for at least 2 months before starting the study Patients who agreed to join the study and signed written consent.

Exclusion Criteria:

* pregnant, and lactating females and those with unrealistic expectation.
* Alopecia totalis or universalis or ophiasis or cicatrising alopecia
* Usage of systemic treatment of alopecia areata 2 months prior to the study.
* Any scalp lesion within the treated area
* Bleeding diathesis, severe anemia or platelet disorders
* Medical conditions such as autoimmune diseases.
Hamburg AoRtic Valve cOhoRt

The primary aim of the study is to identify the optimal treatment modality for patients with aortic valve disease, incorporating the individual patient's risk profile and anticipated clinical outcomes. This includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.

Patients with severe aortic valve disease have a poor prognosis under medical therapy, making replacement of the failing valve the preferred option. In addition to surgical aortic valve replacement (SAVR), transcatheter aortic valve implantation (TAVI) has evolved as an alternative treatment option for patients at intermediate and high operative risk. Before expansion of TAVI to low-risk and younger patients can be recommended, several questions remain to be investigated, e.g. optimal patient selection, periprocedural complications and long-term durability. Therefore every patient with a relevant aortic valve disease (aortic stenosis, aortic regurgitation or degenerative aortic valve prosthesis) who meets the inclusion/exclusion criterias is planned to be involved in the study.

Predictors of outcome are yet to be defined in patients with aortic valve disease in order to improve risk prediction for the different treatment modalities (medical, SAVR, TAVI).

The primary aim of the study is to identify the optimal treatment modality for the individual patient, incorporating the individual patient's risk profile and anticipated clinical outcomes. This includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically relevant aortic valve disease (aortic valve stenosis, aortic regurgitation, degenerated aortic valve prosthesis)
* Written informed consent

Exclusion Criteria:

* Insufficient knowledge of the German language (able to understand and write the German language)
* Physical or psychological incapability to take part in the investigation