cyrilzakka/clinical-trials huggingface dataset:
Human Papillomavirus and Pregnancy

Purpose Our study involves two hypotheses. One is that genital infection with HPV is associated with increased risk of miscarriage and preterm birth. The second hypothesis is that human papillomavirus can ascend from the vagina to the uterus through the cervix and cross the placental barrier. We wish to verify these hypotheses in our studies.

This study will determine the prevalence of HPV in Danish pregnant women and examine HPV's role in the aetiology of spontaneous abortion and preterm birth.

Background Studies have shown significantly higher prevalence of HPV in tissue from miscarriages (60%) than from induced abortions (20%). HPV-infection in the extravillous trophoblasts in the placenta has furthermore been shown to induce cell death and cause dysfunction of the placenta, which can lead to adverse outcome of the pregnancy, e.g. preterm birth and hereby related neonatal mortality and morbidity. Spontaneous abortion and preterm birth are adverse events of the pregnancy, with for the biggest part unknown aetilogy, an area worth trying to elucidate by means of research.

Method 6 groups of each 91 women will be included:

* A group of early pregnant women at the nuchal translucency scan around gestational week 12 and a similar group undergoing chorion villous sampling in relation to prenatal diagnostics of the fetus
* A group of women with spontaneous abortion before gestational week 22 and a group with preterm birth gestational week 22-32
* A group delivering spontaneously at term and a group undergoing elective cesarean at term

The women will be examined by cervical swab to analyze for and do a genotyping of HPV if present. A vaginal swab will be done for the purpose of vaginal microbiome examination later. Furthermore analysis for HPV in placental tissue from chorion villous sampling or evacuation of the uterus after miscarriage. Cervical swabs and placental tissue will be analyzed by means of PCR (polymerase chain reaction) for the 35 types of HPV most frequently found in the anogenital area. Blood samples will be collected from all the patients and analyzed for HPV-antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women gestational week 10-42

Exclusion Criteria:

* Vaccinated against cervical cancer
Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder

Major Depressive Disorder (MDD) is the leading cause of disability worldwide. Depression and anxiety disorders are among the most prevalent of all mental disorders, with an estimated annual prevalence of 9.7% and 18.1% respectively.

It has been known for the last 100 years that depression and anxiety both likely affect vocal acoustic properties. In 1921, Emil Kraepelin, characterized depressed patient's voices as having a lower pitch, lower volume, lower rate of speech, more monotony of prosody as well as more hesitations, stuttering, and whispering.

Mechanistically, it is possible that the neural circuitry involved in the pathophysiology of mood and anxiety disorders impinge upon the neural circuit involved in speech production, affecting qualities that include rate, prosody, speech latency and other paralinguistic features. Thus, acoustic features of speech may be one of the more readily accessible biomarkers for these conditions.

Given this understanding, the investigators sought to develop a passive vocal biomarker instrument for depression and anxiety screening that could markedly expand access as well as standardize the quality of screening in primary care settings.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and or females over the age of 18 at the time of informed consent
* Access to a laptop, smartphone or tablet with a functioning microphone
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Fluency in English
* For depressed participant group: Current diagnosis of depression
* For non-depressed participant group: No current or prior diagnosis of depression

Exclusion Criteria:

* Visual impairment that would make it difficult for the participant to follow the instructions
* Motor impairment that would make it difficult for the participant to follow the instructions
* Any known history of neurodegenerative or Central Nervous System disorders (e.g. MS, Dementia, TBI, Stroke, etc.)
* Any known history of major psychiatric disorder other than depression (e.g. Bipolar Disorder, Schizophrenia, etc.)
* Any known history of substance abuse
Pharmacokinetics of Off Label Pediatric Medications

The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.

There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Children less than 8 years of age
* Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care

Exclusion Criteria:

* Lack of consent
Mitigating Suicide Risk With Single Session 'Brief Skills for Safer Living'

Mental health concerns have been on the rise since the onset of the COVID-19 pandemic. The pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and loneliness. Timely and easy access to mental health services is a dire need, and this study will test the efficacy and feasibility of a brief clinical intervention, Brief Skills for Safer Living (Brief-SfSL), at reducing suicide risk. The goal of this study is to investigate whether Brief-SfSL, delivered online, is a suitable, acceptable and effective method for reducing suicide risk and providing timely mental health services. The results from this study will provide vital insight into effective interventions for suicide risk that are accessible and can be widely distributed.

This study will test a brief online clinical intervention targeting suicide risk that will be delivered widely, remotely, rapidly and with minimal load on the healthcare system in Canada. The "Skills for Safer Living" (SfSL) intervention, a transdiagnostic 20-week group therapy intervention designed to teach concepts, skills and coping strategies through modules targeting common areas of deficits (Personal Safety, Emotional Literacy, Interpersonal Relationships and Problem-Solving), will be adapted into a single session "Brief-SfSL" that can be delivered in an online format. The proposed study will test the effectiveness of Brief-SfSL on reducing suicide risk, as measured by reductions in suicidal ideation after 3 months, and will provide evidence for a scalable intervention that can broadly reach urban and rural communities. Lack of suicide intervention services is an immense unmet need that is especially pronounced during this pandemic and is associated with increased burden on individuals and on the healthcare system. Considering the long wait times to access consistent psychiatric services, this proposed intervention is an essential step in providing evidence-based accessible suicide risk services during and even beyond the pandemic.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Experiencing suicidal ideation in the past week (Beck Suicide Scale\>10)
* Ability to undergo psychotherapy in English
* Access to a computer with a camera or a mobile phone with a camera
* Access to internet
* Access to an emergency contact and hospital within commuting distance
* Not receiving other psychotherapy concurrently
* Willing to have the session recorded to review therapy fidelity
* Follow-up visits with a psychiatrist or family doctor where a psychotherapeutic modality (e.g. DBT, psychodynamic therapy, etc.) is not being used are allowable.

Exclusion Criteria:

* The presence of cognitive impairment that would limit consent or understanding of Brief-SfSL
* The presence of active psychosis
* Current substance use disorder
* Unwilling or unable to provide informed consent
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment

Due to the high prevalence of malocclusions in Mexico and the existing concern to improve aesthetics, function (chewing), or both, patients resort to orthodontic treatment. The patient may experience pain during treatment due to the release of different chemical mediators such as RANK-L. Analgesic and anti-inflammatory medications such as acetaminophen and ketorolac are used to control pain during orthodontic tooth movement. These drugs can inhibit the expression of RANK-L which can affect tooth movement, inhibiting bone remodeling. The orthodontist should indicate the drug that is safest for the patient without affecting treatment or tooth movement.

Objective: To evaluate the association of RANK-L levels with the administration of paracetamol and ketorolac in patients starting orthodontic treatment.

Material and methods: A double-blind clinical trial will be carried out with a placebo control group and random drug allocation. Patients who begin orthodontic treatment in the Orthodontic Specialty of the Comprehensive Dental Clinics of the University Center for Health Sciences and who decide to participate in the study with the signing of informed consent will be included. Three groups will be formed with 8 patients in each one.

The first group will be administered with Placebo (calcined magnesia), the second group with Ketorolac and the third group with Paracetamol, for all groups the medication will be one capsule every 6 hours for 5 days all study subjects will be sampled Gingival Crevicular Fluid (LGC), Visual Analogue Pain Scale (APS) and Intermolar Space (IS).

Measurements will be made four times; baseline, 24 h, 48 h, and on day 5 of initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes between 18 and 27 years of age
* Periodontally and systematically healthy
* Attended the Orthodontic Clinic of the University of Guadalajara
* Who required the use of dental spacers in at least one quadrant were included

Exclusion Criteria:

* Patients who have previously had orthodontic treatment or are under orthodontic treatment
* Who have an allergy to ketorolac or paracetamol
* Who are under pharmacological treatment and/or using contraceptives
* Pregnant or lactating women, as well as those who consume alcohol were not included or tobacco.
A Study Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome is a functional lower gastrointestinal disorder characterised by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms. Irritable bowel syndrome has a prevalence of approximately 10% in adults, shows a female preponderance, and is more common in younger individuals. In clinical practice, Irritable bowel syndrome accounts for almost a third of all gastroenterology cases seen in primary care, with a subsequent third of these being referred onto secondary-care for further evaluation. The economic burden of Irritable bowel syndrome, in terms of medical expense, work absenteeism and loss of productivity, is considerable.

The exact cause of irritable bowel syndrome is unknown. Accordingly there has been a huge surge in interest for dietary therapies to help manage Irritable bowel syndrome. To date, there are only a handful of small randomized controlled trials evaluating the efficacy of dietary therapy in Irritable bowel syndrome. In light of this we plan to conduct the first randomized controlled trial directly comparing the effectiveness of the low-FODMAP diet, British Dietetic Association diet, and the gluten free diet in Irritable bowel syndrome. Moreover, such a trial allows for a direct comparison of nutritional and gut microbial changes, both of which can suffer detrimental consequences following the implementation of restrictive dietary therapies. This study is also unique in that it takes into consideration the patients' perspective with regards to the convenience and cost-effectiveness of implementing such diets into routine day-to-day life. The study will aim to recruit 100 patients from Sheffield Teaching Hospitals gastrointestinal clinics. Following recruitment patients will be seen by a hospital dietitian where they will be randomized to one of the 3 diets. Participants will complete a questionnaire portfolio weekly for one month as part of the study


Eligibility Criteria:
Inclusion Criteria:

1. Irritable Bowel syndrome - as defined by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms.This is the contemporary definition as provided by the Rome IV committee.
2. Age 18-65 years
3. English literate
4. Can travel to hospital
5. Telephone/internet access

Exclusion Criteria:

1. Inflammatory bowel disease
2. Coeliac disease
3. Gastrointestinal cancer
4. Previous abdominal surgery
5. Scleroderma
6. Poorly controlled diabetes
7. Severe liver disease
8. Severe renal disease
9. Severe respiratory disease
10. Severe cardiac disease
11. Severe psychiatric disease
12. Memory disorders
13. Pregnant
14. Current dietary interventions
15. Recent/current use of Probiotics
16. Recent/current use of Antibiotics
17. Recent/current use of Narcotics
18. Currently titrated antidepressants (i.e. not on a stable dose)
Plyometric Exercises in Ankle Range of Motion and Sural Triceps Strength in the Jump in Basketball Players

The objective of plyometric exercises is to improve the range of mobility of the ankle, as well as decrease the stiffness of this joint and increase the strength in the sural triceps, by improving the explosive elastic force.

The objective of the study is to assess the efficacy of plyometric exercises in increasing ankle mobility and increasing strength in the sural triceps, in professional female basketball players aged 18 to 40 years.

Randomized, simple blind clinical study. 48 basketball players will be randomized to the two study groups: experimental (they will perform the Counter Movement Jump (CMJ) and Drop Jump (DJ) exercises) and control (they will follow their usual routine). The intervention will last 4 weeks, with 2 weekly sessions of 15 minutes each. The study variables will be: range of dorsal flexion movement of the ankle (goniometry) and strength of the sural triceps (My Jump 2). A descriptive statistical analysis will be performed calculating the main statistical characteristics. The sample distribution will be analyzed with the Kolmogorov-Smirnov test. The changes after each evaluation will be analyzed with the t-student test for related samples and with the ANOVA test of repeated measures the intra and intersubject effect will be observed. Cohen's formula will be used to calculate the effect size.

It is intended to observe improvement in the range of dorsal ankle flexion movement and strength in the sural triceps.


Eligibility Criteria:
Inclusion Criteria:

* Basketball players
* Female
* Federated and professional
* With an age range of 18 to 40 years
* With more than 4 years of basketball sports

Exclusion Criteria:

* Athletes who have been injured in the last two months
* Who suffer an injury during the intervention process
* Have not signed the informed consent document
Infloran® for Prevention of Necrotizing Enterocolitis

Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies in preterm neonates and a leading cause of death and morbidity.

The pathogenesis of NEC remains largely unclear, but it is widely considered as a multifactorial disease. Prematurity, enteral feeding, bacterial colonisation of the gut and intestinal ischemia have been proposed as major risk factors.

Probiotics may prevent NEC by improving the maturity and function of the gut mucosal barrier, modulating the immune system, promoting colonization of the gut with beneficial organisms and preventing colonization by pathogens.

A variety of clinical trials have evaluated the effect of different probiotic preparations on the occurrence of NEC in preterm infants. The results of recent metaanalyses suggest a benefit of probiotic bacteria in reducing the incidence of NEC and propose a change of practice.

The aim of the study is to evaluate the efficacy of the probiotic preparation Infloran® in reducing the incidence of NEC after implementation in clinical routine in preterm (\< 34 weeks gestational age) very low birth weight infants compared to a historical cohort.


Eligibility Criteria:
Inclusion Criteria:

* Neonates admitted to the neonatal intensive care unit on day 1 of life
* Very low birth weight (\<1500 gram)
* Prematurity \< 34/0 weeks gestational age
* For group receiving probiotics: 230 infants born after the 20/Sep/2010 (i.e. date of introduction of Infloran in clinical routine)
* For control group (historical): 230 infants born before 2010

Exclusion Criteria:

* Malformation of the gut (omphalocele, gastroschisis, intestinal atresia)
* Death before seven days of life, except due to NEC
* Transfer to another hospital before 37 weeks of corrected gestational age, except those who were transferred to a partner clinic using the same protocol for probiotic supplementation
* For group receiving probiotics: Infants who did not receive Infloran® starting in the first week of life or stopped before 34 weeks gestational age, except infants who developed NEC (reason for discontinuation of Infloran)
Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity

Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger flexors) Methods: Patients will be randomly assigned to one of 5 groups. Gp 1: placebo, Gp 2: 15U, Gp 3: 30 U, Gp 4: 50 U, Gp 5: 75 U

Seventy-eight patients with upper extremity spasticity after cerebrovascular accident will be recruited and randomly assigned to one of 5 groups. The groups are as followings.

Gp 1: placebo group (Normal saline 1.2 ml) Gp 2: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U Gp 3: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U Gp 4: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U Gp 5: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U

According to the group, the injection will be performed to the finger flexor musles (flexor digitorum superficialis and profundus). Outcome measurement will be MAS (Modified ashworth scale), FMA, Wolf Motor Assessment, Cross sectional area measured by Ultrasonography.

Patient evaluation will be conducted 2 weeks, 1 months, 2 months, and 3 months after the injection.

Eligibility Criteria:
Inclusion Criteria:

* over 6 weeks after stroke onset
* MAS (modified Ashworth scale) greater than 2 in finger flexor

Exclusion Criteria:

* neuromuscular junction disease or motor neuron disease
* phenol or alcohol block for the target limbs within 6 months before screening
* botulinum toxin injection within 3 months before screening
* history or plan for tendon lengthening surgery
* significant contracture ormuscle atrophy at the target joint or muscle
* concurrent treatment with intrathecal baclofen
* hypersensitivity or allergy to study drug or its components
* pregnancy or planned pregnancy, breastfeeding
* abnormal lab findings for alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, and serum creatinine.
Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease

In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. As the primary target of SGLT2i is expressed mostly in the kidneys, the efficacy of SGLT2i in patients with ESRD may be limited. On the other hand, patients with ESRD are at higher risks of experiencing cardiovascular events and may still benefit from treatment. Several mechanistic studies have demonstrated direct actions of SGLT2i on the myocardium, thus it is possible that the benefits of SGLT2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure/ESRD were similar to those in subjects with normal renal function. The use of empagliflozin in patients with ESRD seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years old
* ESRD under chronic, maintenance hemodialysis with stable dry weight for the past 6 months
* Documented left ventricular ejection fraction \<50% by any imaging modality within 1 month of screening

Exclusion Criteria:

* Age \<20 years old
* Ongoing pregnancy
* NYHA class IV heart failure
* Any hospitalization for heart failure within the past month
* Ongoing acute urinary tract infection at the time of screening
* Known acute genital infection
* Severe peripheral artery disease (Rutherford category 4-6)
* Acute coronary syndrome, stroke or transient ischemic attack within the past month
* Recent initiation of chronic maintenance hemodialysis within 6 months
* Adjustment of dry weight with changes greater than 5% of body weight within the past month
* Documented left ventricular ejection fraction ≥50% by any imaging modality within 1 month of screening
* Refused informed consent
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective than radiation therapy for testicular cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.

OBJECTIVES: I. Compare relapse rates in patients with stage I testicular seminoma treated with adjuvant radiotherapy vs carboplatin. II. Compare quality of life of patients before and after treatment with these regimens. III. Compare the acute and intermediate (1-2 year) side effects of these regimens in these patients. IV. Determine the incidence of late side effects (such as bowel dysfunction) of treatment and second malignancies in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive a single dose of carboplatin IV. Arm II: Patients undergo radiotherapy once daily, 5 days a week. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed stage I seminomatous germ cell tumor of the testis categorized as either "classical" or "anaplastic"

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.4 mg/dL Other: No concurrent or previously treated malignancy except successfully treated nonmelanoma skin cancer No medical condition or other factor that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No more than 8 weeks since prior orchidectomy Prior inguino-pelvic or scrotal surgery allowed Must be treated with "dog-leg" field if randomized to radiotherapy If prior vasectomy, choice of fields is at the discretion of the clinician