cyrilzakka/clinical-trials huggingface dataset:
Covid-19 Vaccine Immune Response in Multiple Sclerosis

Coronavirus (Covid-19) has affected millions of people worldwide. Vaccines to prevent Covid-19 infection have been offered to reduce the risk of infection. While these vaccines have been offered to people with multiple sclerosis (MS), they have not been tested in these individuals. It is uncertain whether people with MS will develop protective antibodies after a Covid-19 vaccination and how long these antibodies will last.

The investigators are planning to study the immune response to the full course of Covid-19 vaccine in people with MS (study group) and compare this to people without MS or immune suppression (control group).


Eligibility Criteria:
Inclusion Criteria (Study Group - MS Patients):

* Aged 18 years and over
* Diagnosis of Multiple Sclerosis as per McDonald's Criteria 2017
* Falls into one of following the Disease Modification Treatment (DMT) groups: on Ocrelizumab, on Natalizumab, on Alemtuzumab, on Tecfidera, on Fingolimod, on Interferon, not on any DMT
* Has had a complete course of Covid-19 vaccination including any boosters (standard dosing: prescribed as per the UK Government guidelines)
* Willing and able to give fully informed consent
* Willing and able to comply with the study procedures

Exclusion Criteria (Study Group - MS Patients):

* Has declined or does not wish to have Covid-19 vaccine
* Has switched DMT since the date of first dose of Covid-19 vaccine
* Has any other immunological condition or on immune treatment causing immune suppression
* Has declined or does not wish to have Covid-19 vaccine
* Ineligible\* for Covid-19 vaccine (\*Ineligible for health reasons and/or as per Government prioritisation of vaccinations)
* Non-English speaker where translation facilities are insufficient to guarantee informed consent

Inclusion Criteria (Control Group - Healthy Volunteers):

* Aged 18 years and over
* Has had a complete course of Covid-19 vaccination (standard dosing: prescribed as per the UK Government guidelines)
* Willing and able to give fully informed consent
* Willing and able to comply with the study procedures

Exclusion Criteria (Control Group - Healthy Volunteers):

* Has declined or does not wish to have Covid-19 vaccine
* Has MS or another long-term immunological condition
* History of taking any immune treatment causing immune suppression in the last 5 years
* History of any immune conditions or comorbidities known to result in immune suppression within the last 5 years;
* Ineligible\* for Covid-19 vaccine (\*Ineligible for health reasons and/or as per Government prioritisation of vaccinations)
* Currently participating in one or more interventional trials involving immune suppression or immune agent
* Non-English speaker where translation facilities are insufficient to guarantee informed consent
The Prognosis of Early Pregnancy With Post Coital Bleeding

This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women- E.R." at "Meir" Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy). After they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.

This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women E.R" at "Meir" Hospital due to spontaneous -or after intercourse bleeding - bleeding secretions. The women will be divided in to two groups

1. Pregnant women (age 18-40) at 4-23 weeks of pregnancy with spontaneous bleeding or bleeding secretions
2. Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "Women ER" 24 hours after bleeding or bleeding secretions due to intercourse.

The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy) The doctor that had examined the women, will have to fill out questionnaires regarding the bleeding source, the time after intercourse, how long after the intercourse the bleeding had appeared and which kind of examination he had carried out.

A month after their appeal to the E.R. and after they give birth ,the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups, by phone.

Eligibility Criteria:
Inclusion Criteria:

* women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the "Women E.R." due to vaginal bleeding.

Exclusion Criteria:

* age \>40 or \<18
* women with history of more then 3 abortions.
* women with history of more then 2 pre term labor
* ectopic pregnancy
* placental previa
* women who takes anticoagulation therapy
* women with known pathology at cervix.
* women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests.
Neuromuscular Electrical Stimulation Versus Intermittent Pneumatic Compression for Blood Flow

Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used outdated NMES devices.

The objective of this study is to compare the effectiveness of a modern NMES device to intermittent pneumatic compression in terms of blood flow.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* History of heart/respiratory problems
* Pregnancy
* Presence of implants, including cardiac pacemakers and orthopaedic implants
* History of neurological disorder
* History of severe arterial disease or known dermatological problems
* Under 18 years of age or over 40 years of age
Intensive Care Anxiety in SARS-CoV-2 Patients

It should be known by the clinician that COVID-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* COVID PCR +,
* admitted to intensive care,
* conscious, cooperative patients

Exclusion Criteria:

* Having hearing and speaking problems,
* Can't speak Turkish or English,
* who do not have the cognitive level to understand and answer the questions,
* Communication problems such as dementia and Alzheimer's,
* patients receiving sedation
A Trial of Treatment for Trauma-Related Nightmares in Active Duty Military Personnel

The purpose of this study is to obtain preliminary data of the efficacy of Exposure, Relaxation, and Rescripting Therapy for nightmares among active duty military personnel.

This will be a pilot randomized controlled trial to compare the effects of Exposure, Relaxation, and Rescripting Therapy for military populations (ERRT-M) among active duty service members. Participants will be randomized to 5 sessions of ERRT-M (n = 20 ) or to a 5-week waitlist control group (WL; n = 20).

Participants will complete all interviews and self-report measures 1 weeks following treatment or the WL condition and 1 month after completing treatment.

Eligibility Criteria:
Inclusion Criteria:

* Active duty military stationed at Fort Hood as assessed by self-report.
* Able to speak and read English.
* History of a traumatic event.
* Nightmare Disorder
* Stable on psychotropic and/or hypnotic medications and/or interventions for sleep (e.g., Continuous Positive Air Pressure for sleep apnea) administered by other providers for at least one month assessed by self-report and review of medical record.
* Willingness to refrain from beginning new behavioral health or medication treatment for issues pertaining to sleep, PTSD, or nightmares during participation in the study.
* Indication that the SM plans to be in the area for the 5 months following the first assessment

Exclusion Criteria:

* Current suicide or homicide risk meriting crisis intervention.
* Severe brain damage, assessed by the inability to comprehend baseline questionnaires.
* Pregnancy at baseline.
* Serious mental health diagnosis such as bipolar disorder or psychosis, assessed with the pre-treatment health interview and review of medical record.
* Currently taking propranolol.
* Currently engaged in evidence-based treatment for PTSD (i.e., Prolonged Exposure Therapy or Cognitive Processing Therapy) or Insomnia (i.e., Cognitive Behavioral Therapy for Insomnia).
Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Prevention of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial

Background and Rationale Oral mucositis (OM) is one of the most debilitating toxic side effects of radiotherapy and chemotherapy. \]Radiation-induced OM occurs due to the generation of free radicals, which induce mitochondrial dysfunction resulting in increased oxidative stress, DNA damage and cell apoptosis. Epidermal growth factor (EGF) levels were decreased in patients with severe OM, and patients with lower levels of EGF prior to therapy may indicate increased risk of mucosal damage during RT

Objectives:

The purpose of this study is for Evaluation of the efficacy of aloe-vera gel versus standard treatment as a new option in the treatment of radiation-induced oral mucositis

Study population \& Sample size :

40 patient proven to have Head and neck cancer , requiring radiotherapy.

Study Design:

RCT. The patients are randomized and divided into 2 groups , group A will use alovera gel , Group B will use benzylamide gel, EGF will be measured in saliva before and after 4 weeks treatment Methods Patient's visits will be at baseline, 2 weeks and 4 weeks. At follow up visits patients will be instructed to bring back the consumed container to check that they had totally consumed their previous supply before giving them the new one. Saliva collection to measure EGF by ELIZA


Eligibility Criteria:
Inclusion Criteria:

* The study will include patients who are diagnosed with radiation-induced oral mucositis with any of its grades as scored by the world health organization (WHO) oral mucositis grading scale.

Exclusion Criteria:

* patients under the age of 18 ,patients receiving any previous treatment for oral mucositis during the last 2 weeks, allergy to aloe-vera, patients with chronic liver disease, infectious diseases (HIV, HBV,HCV,....), immune system dysfunction, haematological diseases and pregnancy or breast-feeding
Using tDCS in Speech-based Stroke Rehabilitation

The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Monolingual (English)
* Single left-hemisphere CVA
* A minimum of six months post-stroke
* Clinical diagnosis of apraxia of speech
* Normal speech perception
* Passing score on the hearing screening.

Exclusion Criteria:

* Diagnosis of laryngeal voice disorder
* Dysarthria
* History of speech impairment prior to CVA
* Presence of potential tDCS risk factors: damaged skin at site of stimulation;
* Presence of electrically or magnetically activated implant (including pacemaker);
* metal in any part of their body;
* history of medication-resistant epilepsy in the family;
* past history of seizures or unexplained spells of loss of consciousness.
Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma

The project is to measure exposure to outdoor and indoor air pollutants in asthma patients in order to show a possible association between variation in pollutant exposure and the occurrence of exacerbations in these patients

Asthma is a chronic airway disease affecting between 6% and 7% of the French adult population. Asthma is responsible for nearly 1000 deaths each year in France. Air pollution (indoor and outdoor) is responsible for 7 million deaths each year according to the World Health Organization (WHO) assessment published in 2018, including 65,000 in France. Studies monitoring exposure to indoor air pollutants are few in number in asthmatic patients. Very little research has been devoted to continuous monitoring of indoor air quality in homes. Our hypothesis is that variation in exposure to indoor air pollutants, in relation to outdoor air, would have an impact on the occurrence of exacerbations in asthmatic patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age,
* Patient with a confirmed diagnosis of asthma for at least 12 months as defined by the investigator,
* Patient with at least 4 asthma exacerbations in the last year
* Patient sleeping at least 6 nights per week in the same home

Exclusion Criteria:

* Patient who is an active smoker or living with an active smoker,
* Patient with a diagnosis of COPD, ABPA or associated pulmonary fibrosis,
* Patient with an asthma exacerbation within 15 days prior to the inclusion visit,
* Patient with known occupational exposure,
* Patient living in a dwelling that does not allow the installation of sensors (inability to connect the sensor to the power supply, no location for the outdoor sensor...)
* Patient who plans to move in the next 6 months,
* Patient with a life expectancy of less than 6 months,
* Patient who has someone living in their household also included in EXAP,
* Patient who lives in an apartment and does not have a balcony or space for the outdoor sensor,
* Pregnant or breastfeeding women,
A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma

The purpose of this study is to see if taking ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), is reasonable, safe and can stabilize or increase weight along with quality of life in pancreatic cancer patients.

The main things that will happen in this study are: patients will be administered ketorolac for 5 days, blood draws, completion of questionnaires, monitoring physical activity and sleep by wearing a study-provided FitBit along with weight using a study-provided smart scale.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of advanced and refractory pancreatic ductal adenocarcinoma (PDAC) referred to Cedars-Sinai Medical Center (CSMC).
2. Cachexia defined as ≥5% weight loss in the presence of chronic illness, within any 6-month period prior to screening or as documented by the medical physician based on standard diagnosis of cachexia.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky performance status \>50%.
4. Patient must have adequate renal function per below lab values:

   * Creatinine OR measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN.
5. Patient must have access to WiFi for the Smart Scale.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
2. Pregnancy, breastfeeding, or of childbearing potential and not willing to use adequate methods of contraception during the study.
3. Has any known allergies or hypersensitivity to the study drug or allergic reactions to surgical steel or elastomer/rubber.
4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
6. Concurrent use of any other NSAIDs while on study.
7. Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding.
8. Have suspected or confirmed cerebrovascular bleeding, tendency to bleed or bruise easily, incomplete hemostasis (how you body stops bleeding), and at high risk of bleeding.
Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery

The purpose of this study is to examine the efficacy of dose regimen of serratiopeptidase (serodase 5 mg) as a prospective, randomized, parallel, double blind Placebo- controlled study.

A prospective, randomized, parallel, double blind Placebo- controlled study to examine the efficacy of dose regimen of serratiopeptidase (serodase 5 mg) on 112 males and females volunteers in the treatment of inflammation after third molar surgery, comparing drug treatment vs placebo over a period of 20 weeks To assess the dose effectiveness of the dose regimen of Serodase 5 mg; the primary outcomes are trismus and swelling while inflammation is a secondary outcome.the expected duration of participants participation will be around 5 days divided into 4 visits, the time point of the measurment are (0,2,4 and 5 days).

The results are expected to assess the improvement of the maximal interincisal distance, reduction of swelling and improvment in the sensation of post-operative pain.

Eligibility Criteria:
Inclusion Criteria:

* participants presented with impacted lower wisdom tooth needs Buccaneers flap with buccal and distal bone removal.
* male or female 18-50
* participant is willing and able to give informed consent for paricipation in the study.
* Able and willing and able with all study requirments.

Exclusion Criteria:

* other oral surgical procedures during the same session except the removal of supernumerary third molars.
* female subject who is pregnant or lactating
* subjects has participated in any clinical research study within the previous 8 weeks.
* subjects on anti coagulant drugs .
* Unwilling participants to continue the study and those with abnormality of wound healing process.
Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis

The purpose of this study is to evaluate the effect of Losartan on cigarette smoke-induced lung injury in smokers and ex-smokers with and without chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

1. Fulfill one of the group definitions above
2. Age between 35 and 75 years old
3. Clinical diagnosis of chronic bronchitis, defined as productive cough for at least 3 months per year for at least two consecutive years
4. Stable maintenance of all current medication therapy for 3 months, including ARBs for treated groups

Exclusion criteria

1. Current therapy with Angiotensin-converting-enzyme (ACE) inhibitor,or Intolerance to Angiotensin II receptor blockers (ARB)
2. Women of child bearing potential
3. Current use of nonsteroidal antiinflammatory drugs or potassium supplementation, treatment with aliskiren, anticoagulation
4. COPD exacerbation requiring treatment within 6 weeks of the screening visit
5. Oral corticosteroid use within 6 weeks of the screening visit
6. Significant hypoxemia (oxygen saturation \<90% on room air), chronic respiratory failure by history (pCO2 \> 45 mmHg) and forced expiratory volume in 1 second (FEV1) below 40%, clinical evidence of cor pulmonale
7. Untreated arterial hypertension (systolic blood pressure \>140 mm Hg, diastolic blood pressure \> 90 mm Hg)
8. Ability to understand and willingness to sign consent documents
9. Blood pressure less than 100 mm Hg systolic or 70 mm Hg diastolic while standing at the screening visit
10. Cardiac, renal, hepatic (LFTs \> 3x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases that are at the discretion of the investigator, to interfere with participation in study
11. History of renal artery stenosis
12. Concomitant airway disorders other than COPD and chronic bronchitis, such as bronchiectasis and asthma (history and reversible airflow obstruction by American Thoracic Society (ATS) criteria)
13. History of pulmonary malignancies, and any other malignancies in the last 5 years
14. History of thoracic surgery.
15. Acute pulmonary exacerbation within 6 weeks from the Screening Visit.
16. Subjects with no airflow obstruction by spirometry but with a decrease in diffusing capacity of lung for carbon monoxide(DLco) possibly indicating emphysema.
17. Significant exposure to environmental tobacco smoke or atmospheric or occupational pollutants
18. Urine pregnancy positive test at the Screening Visit.
Cancer Development In Organ Transplant Recipients

The investigators will determine the cancer risk in organ transplant recipients compared to the general population with the help of statistical analysis. Secondly the investigators will try to characterize the different cancer types.

This cohort analyses will focus on incident and recurrent cases of development of non-skin cancer over time. We will consider time to first formation of non-skin solid cancer after solid organ transplantation as well as the cumulative number of non-skin solid cancer formation over time. Both aspects are equally important and will be reflected in the analytic methods of this study. Theses analyses will be restricted to the most prevalent transplantation types of heart, kidney, liver, and lung.

Eligibility Criteria:
Inclusion Criteria:

We will select all patients within the STCS based on the date of the first solid organ transplantation. Patients with multiple organ transplantations will be included as well. Patients contribute to the study observation time until death or end of follow-up due to other reasons.

Exclusion Criteria:

We will exclude patients with non-solid organ transplantation (e.g. hematopoietic stem cell transplantation), because the detailing of information in the STCS is insufficient to allow for detailed analysis of cancer development and control of relevant confounders. We will exclude