cyrilzakka/clinical-trials huggingface dataset:
Trial of Pre-Pregnancy Supplements

The purpose of this study is to determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic acid alone.

Globally, more than half a million women die from pregnancy or childbirth-related complications, most of them in developing countries. The global community committed to reducing the maternal mortality ratio by three quarters between 1990 and 2015 (MDG5). Women die from a range of complications in pregnancy, childbirth or the postpartum period. 80% of maternal deaths are due to severe bleeding (mostly bleeding postpartum), infections, hypertensive disorders in pregnancy and obstructed labor. Additionally, low birth weight and neonatal mortality are common problems in developing countries. The benefit of periconceptual folate on preventing congenital anomalies has been established in randomized trials; however, the role of other nutrients needs to be examined further. Anemia is strongly associated with adverse perinatal outcomes including maternal mortality and low birthweight.

Eligibility Criteria:
Inclusion Criteria:

1. Girls aged \> =15 years and \<= 29 years
2. Have not missed a menstrual period during recruitment (no amenorrhea)
3. Has not been pregnant or given birth within the last 6 months
4. Intend to stay in the study area for at least 6 months after enrollment
5. Have provided written informed consent

Exclusion Criteria:

1. Amenorrhea or confirmed pregnancy at screening or enrollment.
2. Has given birth within 6 months
3. Already taking long-term vitamin supplementation.
4. Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home).
Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

The goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (MSC) to induce bone regeneration in patients with periodontal disease. MSC cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect.

The clinical protocol is designed to evaluate the bone regeneration capacity of allogeneic MSCs for the treatment of patients with chronic or aggressive periodontal disease. Patients with either a 2- or 3-wall intrabony defects are included in this study. A bioengineering construct, constituted by allogeneic MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, which is implanted at the bone defect site. Follow up of treated tooth are assessed by clinical evaluation, intraoral radiography and cone-beam CT.

Eligibility Criteria:
Inclusion Criteria:

* Medical healthy
* Minimum age of 18 years old
* Diagnosis of chronic or aggressive periodontitis
* Vertical intrabony defects of three or two walls
* PPD \>= 5 mm
* Radiographic evidence of alveolar bone loss of at least 3 mm
* Minimim 20 teeth presents in mouth.
* Informed consent of the patient

Exclusion Criteria:

* Smoking
* Pregnancy or lactating
* Receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs
* Diabetics
Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject-reported history of dry eye disease in both eyes for at least 6 months;
* History of use of artificial tear eye drops for dry eye symptoms;
* Total score of ≥40 on SANDE;
* TFBUT;
* Corneal fluorescein staining;
* Lissamine green conjunctival staining;
* Schirmer's test score.

Exclusion Criteria:

* Have participated in a previous tavilermide (MIM-D3) study;
* Have clinically significant slit lamp findings at Visit 1;
* Have a history of lacrimal duct obstruction within 12 months of Visit 1;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days prior to Visit 1.
Bioavailability of Astaxanthin Formulations

Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose.

Comparison of the bioavailability of 3 formulations with astaxanthin in healthy volunteers after single dose

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have signed an informed consent form and who meet all of the following entrance criteria may be enrolled in this clinical trial: Generally, healthy men and women who are 21 to 50 years of age, inclusive, at the baseline visit.

Exclusion Criteria:

* 1. Are unwilling to follow the procedures of the trial, such as making visits or having their blood drawn.

  2. Have unintentionally lost or gained 10 or more kg of body weight in the last 3 months; 3. Have an acute illness (such as a severe cold or flu) or have been hospitalized within the past month for certain conditions; 4. Have severe co-morbid disease including cardiac, pulmonary, renal, hepatic, carotid, peripheral vascular disease, stroke, neurological, clotting disorders or active cancer; 5. Taking chronic drugs which interfere with lipids metabolism (statins or similar) 6. Consume alcohol at an elevated level (Defined as consumption of more than 10 standard alcoholic drinks per week. A standard alcoholic drink is defined as one bottle/can of beer or one glass of wine equals one portion of hard liquor).

  7. Consume carotenoids as food supplements. 8. Have a Body Mass Index (BMI) of less than 17 or greater than 35 m/kg2; 9. Have participated in a clinical trial in the past 4 weeks; 10. Have any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject; 11. Smokers 12. Pregnant woman
The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health

Common mental disorders can be disabling and lead to a large burden of disease. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was developed to address emotional disorders with evidence-based emotional-focused cognitive-behavioural techniques and is efficacious in reducing anxiety symptoms and depressive symptoms in adults. Previous research has demonstrated comparable effect of UP on reducing anxiety symptoms compared with the single-disorder protocol (SDP) for anxiety. Group-based UP was also implemented and tested. Given the fact that working populations are at a high risk of poor mental health, especially in light of the COVID pandemic with new unprecedented work situations and increased uncertainties, the present study aims to investigate the efficacy of Unified protocol on sleep and mental health in high-risk population.


Eligibility Criteria:
Inclusion Criteria:

* Working in local schools or education institutions
* aged 18 or above
* no severe or unstable mental health conditions at recruitment
* no extensive prior training/practice with mindfulness

Exclusion Criteria:

* psychotic disorders, bipolar disorder, severe alcohol disorder and substance abuse, acute and high suicidal risk
* currently receiving taking other psychosocial interventions
Heart Risk 6 Scale in Emergency Department Acute Heart Failure Patients

Detect the predictive value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in emergency department acute heart failure patients in Egyptian population

Recently, the heartrisk6 scale was introduced to predict the short-term serious outcomes in emergency department acute heart failure patients. It was created from 3 cohorts from American and Canadian population. Since the Egyptian population differ from the American and Canadian population regarding the age at presentation with cardiovascular disease, risk factors and etiology of the acute heart failure, we sought to detect the applicability of this score on our population.

Eligibility Criteria:
Inclusion Criteria:

* patients who have appropriate symptoms (short-ness of breath or fatigue)(\<7 days duration); with clinical signs of ﬂuid retention (pulmonary or peripheral) in the presence of an underlying abnormality of cardiac structure or function.

  * If in doubt, a beneﬁcial response to treatment (eg, a brisk diuresis accompanied by improvement in breathlessness) will be considered.

Exclusion Criteria:

* Patients who did not ﬁt the deﬁnition of AHF or who were clearly too ill to be considered for discharge after 24 hours from ED:

  * 1) resting oxygen saturation \<85% on room air
  * 2) heart rate \>120 beats/min;
  * 3) systolic blood pressure \<85 mm Hg;
  * 4) confusion, disorientation, dementia;
  * 5) primary presentation for ischemic chest pain requiring treatment or with acute ischemic ST-Tchanges on initial electrocardiogram (ECG);
Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum

This investigation is designed to evaluate the acid neutralisation action of a new test product versus unmatched placebo.

The primary objective of this confirmatory clinical investigation is to evaluate the acid neutralisation action of a calcite chewing gum, by comparing the antacid action with an unmatched placebo chewing gum. The clinical investigation will also assess the efficacy and safety of the calcite chewing gum.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with a primary diagnosis of symptomatic GORD in accordance with the Montreal definition. Patients must have experienced frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of mild/moderate intensity. If the patient also has other symptoms, the heartburn, regurgitation or dyspepsia should be the predominant symptoms.
2. Patient that are healthy (with the exception of a diagnosis of GORD) as determined by past medical history and vital signs at screening.

Exclusion Criteria:

1. Patients with a history or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) or hiatus hernia which is greater than 3 cm or a history of conditions that can lead to abnormal oesophageal pH.
2. Patients experiencing frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of severe intensity
3. Patients who are unwilling to refrain from using antacids or alginates 24 hours prior to the start of the treatment visit.
4. Patients who are unwilling to refrain from using proton pump inhibitors (PPIs), H2 antagonists, motility stimulants or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to the start of treatment period.
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Completion of parent clinical trial for treatment of partial seizures.

Exclusion Criteria:

* Receiving any study drug or experimental device other than lacosamide.
* Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.
Bispectral Index Under Propofol Anesthesia in Children : a Study Between TIVA and TCI

In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI SBIS).

Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias and imprecision will be calculated.


Eligibility Criteria:
Inclusion Criteria:

* weighting more than 15 kg;
* American Society of Anesthesiologists physical status I or II
* scheduled for middle ear surgery

Exclusion Criteria:

* cardiovascular, neurological, hepatic or renal impairment, if their body mass index was above 95th percentile or if they received any drug interfering with the central nervous system.
Effects of Baclofen on Presynaptic Inhibition in Humans

This study examines the role of the GABA-B receptor in long-lasting presynaptic inhibition of primary afferents in human participants. Participants will come in for two visits, receiving baclofen (a GABA-B receptor agonist) on one visit and a placebo during the other. Electro-physiological measures will be use during both visit to asses presynaptic inhibition.

The ability to execute purposeful movements relies on sensory information coming from the body. This sensory information tells us where are limbs are in relation to the rest of our body (posture sense), how fast they are moving (kinesthetic sense), how forcefully we are making a contraction (muscular sense) and if we are being contacted by external objects, changes in temperature, pain, etc (somatic sense). Without these senses, the investigators could not make well-controlled movements or navigate in our environment safely. Because of the importance of these sensory inputs, the nervous system has designed a highly regulated system to control the amount and quality of sensory inflow entering into both the spinal cord and brain. The investigators wish to re-investigate how sensory pathways from our body controls the inflow of sensory inputs in adults with and without neurological injury. Specifically, the investigators want to test if the long-lasting suppression of sensory inflow by other sensory nerves is regulated by GABA-B receptors. The investigators will test this by giving participants the GABA-B receptor agonist baclofen. Nerve stimulation and muscle responses will be used to understand how sensory transmission is being controlled in the spinal cord and the GABA-B receptors involvement. Results from these studies will provide important fundamental information about how normal sensory inflow is controlled so that the investigators can better understand how it may be altered after injury to the brain and spinal cord. This information will open new avenues of study into the treatment of sensory-related dysfunction such as spasticity and motor incoordination that occurs after central nervous system injury or disease.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 18 and 65 years.
* General good health

Exclusion Criteria:

* Contraindications to baclofen such as a known hypersensitivity to baclofen, renal impairment, stroke, epilepsy, pregnancy and lactation.
* Injury to peripheral nerves or muscles. Injury to nerves or muscles will confound the interpretation of the spinal reflex data.
* Participants with spinal cord injury already taking oral baclofen to manage spasticity.
Comparative Analysis of APACHE II and P-POSSUM

To compare APACHE II and P-POSSUM scoring system in emergency laparotomy.

To compare APACHE II and P-POSSUM scoring system in predicting postoperative mortality in patients undergoing emergency laparotomy.

Eligibility Criteria:
Inclusion Criteria:

* All patients above 18 years of age undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 will be included in the study.

Exclusion Criteria:

* Patients willingly seeking referral to a different hospital
Anti-inflammatory Effect of Atorvastatin in Atherosclerotic Plaques Assessed by FDG-PET Imaging

The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with accumulation of FDG-PET in carotid artery or aorta

Exclusion Criteria:

* LDL cholesterol level (calculated by using Friedewald formula) higher than 180 mg/dl or less than 120 mg/dl
* subjects currently taking HMG CoA-reductase (Statins) or fibrates
* symptomatic coronary artery diseases
* symptomatic cerebrovascular diseases
* subjects suffered from myocardial infarction or stroke within 6 months
* subjects underwent percutaneous vascular interventions or vascular operations within 6 months
* diabetic patients with poor glycemic control (HbA1c\>8.5)
* hypertensive patients with poor blood pressure control
* subjects with neoplasms
* subjects with systemic inflammatory diseases
Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients

Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn the investigators' attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, the investigators report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer.

Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma.

Although the majority of patients with nasopharyngeal carcinoma (NPC) do not present with overt metastases at diagnosis, a significant number succumb to disseminated disease years after the successful treatment of the primary tumor. Thus, late NPC recurrence may be the result of rare and elusive dormant cancer cells hiding in specialized niches being reactivated by specific signals. The concept of cancer dormancy has been described for the most common solid and hematological cancers; however, the dormant cancer cells in NPC remain largely uncharacterized.

Although many factors contribute toward cancer cell dormancy, recent studies have demonstrated that cancer therapy can induce cellular dormancy. Indeed, therapy-induced dormancy has been shown to lead to durable proliferation arrest, resulting in the formation of polyploid giant cancer cells (PGCCs), which are a unique sub-population of cancer cells that contribute toward the heterogeneity of solid tumors. Unlike regular-sized diploid cancer cells, PGCCs display distinct morphological features, including a large cytoplasmic area and a high genomic content contained within a single highly enlarged nucleus or multiple nuclei. Despite being present in low numbers, the frequency of PGCCs increases markedly after exposure to hypoxia and therapeutic interventions such as radiotherapy and chemotherapies.

The investigators' findings, which used a highly relevant clinical orthotopic model of imageable NPC and clinical data, suggest that autophagy inhibition (HCQ) prevents therapy-induced dormant PGCC formation and thereby prevents NPC metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of NPC.
* Have not received any cancer therapies
* Must provide informed consent

Exclusion Criteria:

* With metastasis before the first treatment.
Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications. Nicotine cessation is rarely addressed in breast cancer patients at the time of diagnosis and may be a missed opportunity to optimize patient outcomes. Patients that use nicotine products are not offered reconstruction at time of mastectomy or oncoplastics at the time of lumpectomy, which can be emotionally distressing in women with breast cancer. Reconstruction could be an additional motivating factor in nicotine cessation success.

This study aims to evaluate the feasibility of a nicotine cessation program designed by Area Health Education Center (AHEC) in the target population. The study is designed to test the acceptability, and preliminary efficacy of a formal nicotine cessation program in women actively using nicotine products with breast cancer recommended for reconstructive or oncoplastics surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age and ≤ 80 years of age.
* Women who are diagnosed with Stage 0 - 3 breast cancer confirmed by biopsy
* Women who have been recommended to have reconstruction at time of mastectomy or oncoplastics at time of lumpectomy
* Participants who actively use nicotine products defined as any self-reported nicotine use within the past month
* Participant agrees to comply with all the study-related procedures.

Exclusion Criteria:

* Patients not eligible for reconstruction or oncoplastics for other reasons including BMI\>35 or inflammatory breast cancer or based on surgeon discretion.
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
* Patients unable to complete the sessions because of language, travel or technology barriers
* Patients already actively participating in another cessation program
* Patients who are pregnant.
Cerebral Dynamic Perfusion Study With Spectral CT in Patients Suspected of Stroke

* Generate a dynamic mapping of the distribution of iodine within the cerebral parenchyma in the patient suspected of acute ischemic disorder with the CT spectral scanner.
* Correlate the anomalies of iodine mapping to the other parameters acquired during the classic dynamic infusion phase to define the ischemic area (MTT higher and rCBV normal) versus infarcted zone (MTT higher and rCBV decreased)


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of hyperacute stroke (6 hours after onset of symptoms)
* Age between 50 and 95 years
* Weight: between 65 and 95 kg

Exclusion Criteria:

* Documented or suspected allergy to IV iodinated contrast media
* Renal impairment with creatinine clearance \<60 ml / min
* Hemorrhagic lesions or vascular abnormalities demonstrated on CT before contrast injection