cyrilzakka/clinical-trials huggingface dataset:
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume

The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (by study subject or appropriate legal representative) prior to any study-related procedure not part of normal medical care
* Planned primary CABG surgery including the use of cardio-pulmonary bypass.

Exclusion Criteria:

* Planned concomitant surgery including ASD repair, valve replacement, carotid endarterectomy, CABG combined procedures or any repeat sternotomy;
* Body weight \<55 kg;
* Planned hypothermia (\<28ºC);
* Planned transfusion in the peri-operative or post-operative periods;
* Planned transfusion of pre-operatively donated autologous blood;
* Female subjects who are pregnant or lactating;
* Planned use of desmopressin, lysine analogs, atrial natriuretic hormone or recombinant activated Factor VII;
* Planned use of corticosteroids in the pump prime solution;
* Ejection fraction \<30% within 90 days prior to surgery;
* Evidence of a myocardial infarction within 5 days prior to surgery;
* History of stroke or transient ischemic attack within 3 months prior to surgery;
* Hypotension or heart failure requiring the use of inotropes or mechanical devices within 24 hours prior to surgery;
* Serum creatinine \>2.0 mg/dL within 48 hours prior to surgery;
* Serum hepatic enzymes above 2.5 times the upper limit of normal for the applicable laboratory;
* Hematocrit \<32% within 48 hours prior to surgery;
* Platelet count below the normal range for the applicable laboratory within 14 days prior to surgery;
* History of, or family history of, bleeding or clotting disorder or thrombophilia;
* History of heparin-induced thrombocytopenia;
* Prothrombin time and/or activated partial thromboplastin time \>1.5 X normal range;
* Serious intercurrent illness or active infection;
* Any previous exposure to ecallantide;
* Receipt of an investigational drug or device 30 days prior to participation in the current study;
* Known allergy to any agent expected to be used in the intra-operative or post-operative periods; and
* Administration of: Eptifibatide within 6 hours prior to surgery, Tirofiban HCl within 6 hours prior to surgery, \*Enoxaparin sodium or other low-molecular-weight heparin \<24 hours prior to surgery, Clopidogrel within 5 days prior to surgery, Ticlopidine within 7 days prior to surgery, Abciximab within 5 days prior to surgery, \*Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery, \*Fondaparinux within 72 hours prior to surgery, Prasugrel within 10 days prior to surgery \[\*Prophylactic use permitted for the prevention of deep vein thrombosis.\]
Observational Study: Safety and Effectiveness of Obinutuzumab in Chronic Lymphocytic Leukemia in Argentina

This observational study aims to study the effectiveness and safety of Obinutuzumab in common clinical practice settings in Argentina. The study population comprises all patients with chronic lymphocytic leukemia (CLL) that have received the indication for treatment with Obinutuzumab as per routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Have received at least one dose of Obinutuzumab as per local label and clinical practice.

Exclusion Criteria:

* Included in clinical trial
Fiber's Utilization for Energy and Life

The study aims to evaluate the metabolizable energy of the typical American diet with and without the inclusion of fiber. We hypothesize that including fiber in the diet will decrease the metabolizable energy of the diet resulting in more nutrient loss into the feces and urine.

The study will be a randomized, crossover, controlled feeding trial comprised of 2 experimental periods: 1) control and 2) fiber. Each experimental condition will be 16 days in length. There will be at least a 12-day compliance break between each period. Participants will undergo complete urine and fecal collection for a period five to seven days during the second half of each experimental condition.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 22-75 years
* BMI between 18.5 and 39.9 kg/m2
* Ability to drop-off 1 fecal sample within 15 minutes of defecation
* Ability to pick-up meals daily
* Ability to collect fecal and urine samples daily
* Fasting glucose of \<126 mg/dL

Exclusion Criteria:

* Wheat allergy or intolerance
* Any food allergies or intolerances
* Prior diagnosis of metabolic or gastrointestinal disease (kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, diabetes requiring medication)
* Women that are pregnant, had a baby within the last 12 months, or are lactating.
* Individuals that smoke, use tobacco, abuse drugs, or consume \> 2 alcoholic beverages per day.
* \>5% weight change in the past month or \>10% change in the past year
* Oral antibiotics during the previous 6 weeks
* History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery
* Are unable or unwilling to consume the experimental meals/snacks.
* Taking certain medications (Orlistat, bile binding resins, insulin, oral hypoglycemic agents, laxatives)
* Concurrent enrollment in another dietary, exercise, or medication study
Treatment of Posttraumatic Stress Disorder by Trained Lay Counsellors in an African Refugee Settlement

The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors.

Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with displaced populations. There is a lack of intervention research in these populations.

Te purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of PTSD in a refugee settlement.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of posttraumatic stress disorder

Exclusion Criteria:

* Drug abuse
* Psychosis
* Mental retardation
Development of Achilles Tendon Elongation and Its Effect on Physical Function the First Year After Rupture

The objective of this study is to examine how elongation of the Achilles tendon develops during the first year after rupture among patients with an Achilles tendon rupture, and how it affects physical function.

The aim is to define a cutoff of acceptable elongation dividing the patients who obtain normal physical function (Limb Symmetry Index \> 90%) from those who do not.

Patients treated both operatively and non-operatively will be included.


Eligibility Criteria:
Inclusion Criteria:

* Appointment in the Outpatients Department within 4 days of injury.
* Total Achilles tendon rupture.
* Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
* The patient must be expected to be able to attend rehabilitation and postexaminations.
* The patient must be able to speak and understand Danish.
* The patient must be able to give informed consent.

Exclusion Criteria:

* Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
* Previous rupture of the Achilles tendon in any of the two legs.
* Treated with Fluorquinolons or corticosteroids within the last 6 months.
* In medical treatment of diabetes.
* Suffers from rheumatic disease.
* Other conditions prior to the injury resulting in reduced function of any of the two legs.
* Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
* Inability to lie in prone position on the operating table.
* Terminal illness or severe medical illness: ASA (American Society of Anesthesiologists) score higher than or equal to 3.
Dental Support Device During Breastfeeding as a Mean for Pain Control

Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.

This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

Dental support device is effective in increasing isometric force in different muscle contraction \[1-7\]. In 2009 an avant-garde study \[8\] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.

Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.

This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

Eligibility Criteria:
Inclusion Criteria:

Maternal age 18-45 years. Normal vital signs.

Exclusion Criteria:

Contraindications for breastfeeding. Significant systemic disease that cause pain or require chronic pain relief.
Morphofunctional, Gene, Inflammation Molecules and Oxidative Stress Analysis in Kidney Tissue of COVID-19 Patients

The involvement of the kidneys in patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the outset of the pandemic was associated with high mortality rates worldwide. This was in part due to the generation of an inflammatory process and exacerbated oxidative stress. The present study was initiated to investigate the relationship between morphofunctional changes and gene expression in the kidney tissue of deceased Mexican patients prior to the initiation of vaccination.

The investigator designed a single-center, prospective, cohort study, to analyze and relate the morphofunctional changes and gene expression of inflammatory and oxidative stress molecules in the kidney tissue of men who died from severe COVID-19. A total of 40 percutaneous renal biopsies from deceased patients with severe acute respiratory syndrome coronavirus 2 infection were included in the study and divided into two a groups. One group was preserved in trizol to obtain RNA and total protein, while the remaining sample was fixed in formalin to be examined by staining with hematoxylin and eosin. The histopathological analysis was conducted by an experienced pathologist. The expression of molecules was evaluated by real-time polymerase chain reaction assay (nphs2, slc9a1, cx3cl1, havcr1, slc22a17, sod2, egf, timp2, hmox1, fabp1, and so forth). The following biomarkers were analyzed: interleukin-6, Arginase-1 (Arg-1), Dipeptidyl peptidase-4 (DPP-4), GSTT1, type I gamma-glutamyltransferase (GGT1), Occludin (OCL), CYP3A4, and Claudin-8 (CL-8). Additionally, Western blot analysis was conducted on claudin-5 (CL-5), occludin, HSP70, Nuclear factor erythroid 2-related factor-2 (NRF-2), superoxide dismutase-2 (SOD-2), nicotinamide adenine dinucleotide phosphate dehydrogenase 1 (NQO1), Gamma glutamylcysteine synthase (γ-GCL), and receptor for advanced glycation end products (RAGE). The estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, with the subjects divided into two groups based on their eGFR: \>60 or \<60 ml/min/1.73 m². The statistical analysis was conducted using the Stata program and GraphPad software, version 10.2.3.


Eligibility Criteria:
Inclusion Criteria:

* Not having at least one creatinine measurement.
* Family members will not accept to participate.

Exclusion Criteria:

* Specimens with sub-optimal quality for analysis.
Multimodal MR Imaging in Patients With Glioblastoma Treated With Dendritic Cell Therapy

Malignant gliomas are aggressive tumours with poor prognosis despite the current multimodal treatment. Hence, there is a clear need for new, effective therapies, among which immune therapy has emerged as a promising treatment option.

When interpreting follow-up magnetic resonance (MR) examinations, the radiologist is often confronted with images that are difficult to interpret with the conventional anatomical imaging techniques. The difference between tumour relapse and therapy-mediated changes is not always distinctive.

In this project, the investigators attempt to characterize the inflammatory response with parameters from advanced MRI techniques like MR spectroscopy, MR perfusion imaging and MR-diffusion imaging. These techniques allow characterization of cellular properties like metabolism and tissue structure respectively. Doing so, the investigators will monitor disease evolution in order to timely detect treatment failure, thereby allowing appropriate switch in patient management.


Eligibility Criteria:
Inclusion Criteria:

\*\*\*\* patients enrolled in the HGG 2003 HGG-IMMUNO 2003 trial

Patients, older than 3 and younger than 60 years with relapse of high-grade glioma (anaplastic astrocytoma WHO grade III or glioblastoma multiforme WHO grade IV), histologically diagnosed in the first stage of the disease as well as after relapse or relapse of glioma which was grade II in the First phase but grade III or IV upon relapse are treated with dendritic cell therapy (immunotherapy) as single treatment approach (No radiotherapy and/or chemotherapy).

\*\*\*\* patients enrolled in the HGG 2010 HGG-IMMUNO 2010 trial

* prospective double blind placebo controlled randomised clinical trial HGG-2010 for patients with newly diagnosed glioblastoma in which immunotherapy is integrated in the current standard of care (concommitant radiochemotherapy).

Exclusion Criteria:

minor age
Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars

The following study will be created to evaluate how the location of caries affects the effectiveness of indirect pulp treatment in primary molars. aiding in the development of evidence-based recommendations for pediatric dentists.

A selective case study design will be employed, focusing on primary molars with either occlusal or proximal carious lesions. Children aged between 3 to 7 years meeting the inclusion criteria will be examined clinically and radiographically to assess the extent and location of the carious lesion. Two groups will be involved in the study; primary molars will be submitted to each group based on whether the lesion is proximal or occlusal. Both groups will then receive indirect pulp therapy, and a clinical and radiographic evaluation for one year will be conducted.

The purpose of this study is to examine how the location of caries, whether proximal or occlusal, affects the success rate of IPT in primary molars. Understanding this relationship is essential for developing more tailored clinical approaches in pediatric dentistry to ensure long-term treatment success.

Eligibility Criteria:
Inclusion Criteria:

* Participant criteria:

  1. Children aged between 3-7 years
  2. Children in complete physical and mental health.
  3. Children with free medical history.
  4. Patient with favorable attitudes, which will be assessed by using Frankl behavior rating.

Teeth criteria:

1. Primary molars with active occlusal or proximal deep caries.
2. Teeth with reversible pulpitis
3. Asymptomatic teeth or teeth with provoked pain of short duration
4. Teeth should be restorable.

Exclusion Criteria:

* Clinical signs or symptoms suggesting evidence of pulp degeneration or a non -vital tooth such as:

  * Clinical symptoms or history indicating irreversible pulpitis as (spontaneous pain, throbbing pain).
  * Tenderness to percussion.
  * Soft tissue swelling, abscess, draining fistula or sinus tracts.
  * Pathological Tooth mobility.

Presence of the following Radiographic criteria:

* Periapical or inter-radicular radiolucency.
* Internal or external pathological root resorption.
* Furcation involvement
* Widening of periodontal space.
Prehypertension Among Medical Students in Visakhapatnam and Association With Cardiovascular Risk Factors

Student Investigator = Thakkallapalli Zeeshan Muzahid. The study aims to assess the prevalence of prehypertension among medical students of Andhra Medical College, Visakhapatnam, India and its association with other cardiovascular risk factors - overweight /obesity, diabetes, lipid profile.

275 medical students will be studied and a history taken and examination done with special emphasis on recording of Blood Pressure, measurement of height and weight (\& Body Mass Index) and Waist Circumference in all. Glucose Tolerance Test and Fasting Lipid profile will be measured in a random selection of 30 prehypertensives and 30 normotensives.

Eligibility Criteria:
Inclusion Criteria:

* Medical Students studying MBBS (Bachelor of Medicine \& Bachelor of Surgery) in Andhra Medical College
* clinically healthy
* consent to participate in the study

Exclusion Criteria:

* known cardiovascular disease
* known hypertension
* using antihypertensive or other cardiovascular drugs
* using any drugs that can affect BP, weight, Blood sugar
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a premenopausal female at the time of Screening.
* Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
* Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
* Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
* Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.

Exclusion Criteria:

* Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
* Subject has history of osteoporosis or other metabolic bone disease.
* Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
* Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
* Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
Potential Effect of Topical Imiquimod on Atrial Ectopy in Patients With Actinic Keratosis

The purpose of this study is to determine the potential effect of topically applied 3.75% imiquimod cream on atrial ectopy in actinic keratosis (AK) patients. The primary endpoint is the change in the 24-hour supraventricular premature beat count. The secondary endpoint is the change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time); change in 24-hour mean heart rate; change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts.

This study is a double-blind, randomized, placebo-controlled, 2-way crossover study designed to assess the potential effect of topically applied 3.75% imiquimod cream on atrial ectopy in actinic keratosis (AK) patients. Candidates for study participation will begin screening procedures up to 28 days prior to enrollment. Qualified subjects shall be admitted to the CRU on Day -1 for baseline evaluations and will be randomized to one of two possible treatment sequences. Each subject will receive both the active 3.75% imiquimod cream and the matching placebo in a randomized crossover fashion with a 2-week washout in between each treatment. The application area is the entire face (exclusive of nares, vermilion, periocular areas and ears) or balding scalp. Atrial ectopy will be monitored for 24 hours at Baseline (Day -1; prior to the first dose of study medication), and at the conclusion of each 14-day treatment period using a continuous 12-lead digital Holter recorder.

Adverse events, concomitant medication use, study medication accountability, and subject compliance will be reviewed at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Male and female AK patients with at least 5 typical visible or palpable AK lesions on face or balding scalp
* AK patients in otherwise good general health age 18 years and above
* Female subjects of childbearing potential must be non-pregnant and non-lactating

Exclusion Criteria:

* Previous clinical study participation within 30 days (drug or device)
* Evidence of clinically significant diseases
* History of drug or alcohol abuse
* Subjects with uncontrolled systemic hypertension, NYHA heart failure classification Class \> II, or a history of atrial fibrillation or atrial flutter
* Subjects using imiquimod or interferon within 30 days prior to the first dose of study medication
* Have known allergies to any excipient in the study cream
* Have melanoma anywhere on the body
Mental Health Help-seeking Promotion in Older Adults

The present study aims to examine the effectiveness of descriptive social norm nudges and pictorial social norm nudges in improving mental health help-seeking intention compared to educational information.

This study is a three-arm randomised controlled trial (RCT) in 540 older adults aged 60 years and above recruited through NGOs, testing the utility of revised TPB with baseline data, and the effectiveness of descriptive social norm-nudges (intervention group 1) and pictorial social norm- nudges (intervention group 2) comparing to traditional mental health education (control). Participants will be evenly randomised and receive 1 message/picture per day consecutively for 2 weeks. Researchers blind to group allocation will interview participants at baseline (T0), 2 weeks (post-intervention, T1), and 12 weeks (follow-up, T2). The primary outcomes are changes in subjective norms and help-seeking intention assessed using a revised Chinese version of the theory of planned behaviour questionnaire (C-TPB); secondary outcomes include perceived behavioural control, help-seeking attitude, perceived barriers to help-seeking (C-TPB subscales), and mental health assessed by PHQ-9, GAD-7 and UCLA-3.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 years or above at the time of the baseline assessment
* have no severe mental disorder or cognitive impairment
* have no severe visual impairment
* be able to read Chinese
* have a smartphone with an instant communication application to receive text and images

Exclusion Criteria:

* have severe difficulty in reading and communication
* show imminent suicidal risk at any stage of the study