cyrilzakka/clinical-trials huggingface dataset:
Study of AZD8931 in Patients With Advanced Solid Malignancies

The main purpose of this study is to explore the safety and tolerability of multiple ascending doses (MAD) of AZD8931 in patients with advanced solid malignancies


Eligibility Criteria:
Inclusion Criteria:

* Cancer which is refractory to standard therapies, or for which no standard therapies exist. Inclusion is irrespective of stage of disease or extent of prior therapy.
* Histologically or cytologically confirmed solid, malignant tumour.

Exclusion Criteria:

* Receipt of any of the following treatments within 4 weeks prior to study entry: chemotherapy (within 6 weeks for nitrosurea or mitomycin C), radiotherapy, hormone therapy (except for androgen-deprivation therapy for patients with prostate cancer), immunotherapy and any other anti-cancer therapies.
* Unresolved toxicity (other than stable toxicity) from previous anti-cancer therapy, except alopecia.
* History of documented cardiac failure, angina pectoris requiring antianginal medication, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic \>180 mmHg or diastolic \>100 mmHg), significant valvular disease or history of high risk dysrrhythmia (such as ventricular fibrillation or ventricular tachycardia \[includes ventricular triplets\]).
* Resting ECG with measurable QTc interval of \> 460 msec at 2 or more time-points within a 24-hour time period, or history of prolonged QTc syndrome.
* The presence of any ocular disease or condition that is active or is likely to flare up during the course of the study or any systemic disease/condition that is affecting or has affected the eye in the past and may flare up, or the treatment of which may have an adverse effect on the eye. Eye conditions that are stable and of long standing, such as scars from trauma, pinguecula, atrophic pterygia etc, should not be considered as reasons to exclude the patient.
Frequency Needed for School-based Obesity Intervention

This randomized controlled trial compared changes in Mexican-American, adolescent standardized body mass index (zBMI) from a school-based obesity intervention given zero, one, three, or five days a week.

Efficacious school-based interventions have been intensive making it difficult for interventions to be scaled. The more components there are to an intervention, typically the better the results. Instead of decreasing intensity via the removal of intervention components, this randomized controlled trial aimed to compare changes in Mexican-American adolescent standardized body mass index (zBMI) based on the number of days per week they received a multi-component intervention. Mexican-American middle school students (n=203) with overweight or obesity were recruited from an independent school district in Houston. Students were randomized to receive an obesity intervention with established efficacy zero (control), one, three, or five days/week. In each condition, 80% of intervention time was allocated to physical activity and 20% to nutrition. Directly measured height and weight were used to calculate zBMI.

Eligibility Criteria:
Inclusion Criteria:

1. BMI-for-age (Body Mass Index) percentile ≥ 85
2. Male or female between ages 10 - 17 years
3. Self-identified as Mexican-American

Exclusion Criteria:

1. Student who is pregnant, planning to become pregnant, or becomes pregnant
2. School report of cognitive impairment significantly below average age and/or grade level
3. Use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening
4. Type 1 or 2 diabetes medical diagnosis
Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension in Preeclamptic Patients

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients following cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients following cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥32 weeks
* American Society of Anesthesiologists physical status classification I to III
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Baseline blood pressure ≥160 mmHg
* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a good response with cisplatin or carboplatin, is safe and helps to decrease or stop tumor growth.

This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is sponsoring this trial.

Eligibility Criteria:
Inclusion Criteria:- Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- Additional criteria determined at screening visit Exclusion Criteria:- Having had more than one treatment regimen with carboplatin or cisplatin- Prior treatment with other epothilones (e.g. ixabepilone)- Use of any investigational drug in the last 4 weeks- Previous radiation to the whole pelvis- Symptomatic brain tumors requiring radiation to the brain - Active infection- Pregnant or breast feeding- Additional criteria determined at screening visit
Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Genitio Pelvic Pain

Study will be a randomized clinical trial which will incorporate two different interventions soft tissue release and vaginal dilators use would be administered to the women with genito pelvic pain. Subjects meeting the predetermined inclusion criteria will be divided into two groups using lottery method. Assessment will be done using GPPPD, Vancouver Visual Analogue Scale, female sexual function index and pelvic floor impact questionnaire. Subjects in one group will be treated with soft tissue release and vaginal dilators. And the other will be treated with soft tissue release only. Each subject will receive a total 09 treatment sessions, with 03 treatment sessions per week. Measurements will be recorded at baseline, 5th and 9th treatment session.

Painful sexual intercourse is a common female health problem. It is a complex disorder that often goes neglected. It can be further categorized into superficial or deep, and primary or secondary. Superficial is limited to the vulva or vaginal entrance, while deep means the extension of pain into the deeper parts of the vagina or lower pelvis. Deep dyspareunia is frequently associated with deep penetration. Primary pain initiates at the start of sexual intercourse, while in secondary, pain begins after some time of pain free sexual activity This study will be a randomized clinical trial which will incorporate two different interventions soft tissue release and vaginal dilators use would be administered to the women with genito pelvic pain. Subjects meeting the predetermined inclusion criteria will be divided into two groups using lottery method. Assessment will be done using GPPPD, Vancouver Visual Analogue Scale, female sexual function index and pelvic floor impact questionnaire . Subjects in one group will be treated with soft tissue release and vaginal dilators. And the other will be treated with soft tissue release only. Each subject will receive a total 09 treatment sessions, with 03 treatment sessions per week. Measurements will be recorded at baseline, 5th and 9th treatment session. Recorded values will be analyzed for any change using SPSS21.

Eligibility Criteria:
Inclusion Criteria:

* Women age 20 to 40 years
* Patient fulfilling DSM5 GPPPD criteria
* Pain in genitals before during or after intercourse
* Pain greater than 4 on a 10cm visual analogue scale

Exclusion Criteria:

* • History of pathological conditions like infections

  * Endometriosis
  * Tumors
  * Major psychiatric disorders
  * Painful bladder syndrome
  * Surgery of pelvic organs
  * Any ongoing treatment of genito pelvic pain.
Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section

Cesarean section is one of the most common major surgical operations among women. In 2015, the incidence of cesarean section in Woman Health Hospital in Assiut University accounts for 51.3 % of all deliveries


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who will undergo elective lower segment cesarean section
* term ( ≥ 37 weeks)
* normal fetal heart tracing.

Exclusion Criteria:

* Placenta previa-Rupture uterus
* Classical cesarean section
* Preterm delivery
* Hypertensive disorders of pregnancy
* Bleeding tendency
* Previous history of postpartum hemorrhage
* Concurrent anticoagulant therapy
* Concurrent long-term use of steroids
* Fetal distress
* Antepartum haemorrhage
The Effect of Laser Power and Fiber Traction Speed on the Outcomes of Endovenous Laser Ablation

A multicenter clinical randomized controlled trial, comparing of three different regimens of endovenous laser ablation with equal linear endovenous energy density in patients with insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED) is the main value for standardization EVLA. From many studies, it is known the optimum value of the LEED. However, the same LEED may be obtained by varying the ratio between the laser power and the fiber pullback speed. Power decrease can allow to reduce the incidence of adverse effects of endovenous laser ablation, but keep high efficiency.


Eligibility Criteria:
Inclusion Criteria:

Patients over 18 years old Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 sec No prior treatment of the insufficient GSV Informed consent

Exclusion Criteria:

Acute deep or superficial vein thrombosis Agenesis of deep vein system Vascular malformation or syndrome Post-thrombotic syndrome, occlusive type Pregnancy Phlebectomy on the thigh Immobility Allergy to lidocaine Arterial insufficiency
Aromatherapy Inhaler Use for HSCT Distress

The purpose of this research is to evaluate aromatherapy inhaler use and how it may impact cancer distress and coping by patients in the first few days after hematopoietic stem cell transplant (HSCT).

Phase 1: Transplant Day +1, +2, or +3. Phase 2: Washout Day: Standard of care (SOC) pharmacological intervention only. Phase 3: Transplant Day +3, +4, or +5). Study Completion: Transplant Day +4, +5, or +6.

\*Study activities will occur on a single day for each phase. However, a three-day window for Phases 1 and 3 will allow consideration of patients' ability to participate in the immediate post-transplant period.

Eligibility Criteria:
Inclusion Criteria:

* Autologous and Allogeneic patients admitted to E1 for planned HSCT
* Patients with hematologic malignancies requiring HSCT
* No allergies to lavender or peppermint essential oils
* Must have received chemotherapy during preparative regimen (single or multi-agent regimen)
* Adult patient over 18 years of age
* Able to speak, read, and comprehend English
* Willing and capable of providing informed consent

Exclusion Criteria:

* Patients admitted for Chimeric Antigen Receptor T cell (CART) infusion
* Patients receiving a transplant for a germ cell tumor diagnosis
* Unexpected/unplanned admission (e.g., neutropenic fever, confusion, clinical deterioration)
* Immune effector cell-associated neurotoxicity syndrome (ICANS) grade 1 through 4
* History of scleroderma
* History of atrial fibrillation
* Known history of G6PD deficiency
* Allergic to lavender or peppermint essential oils
* Pediatric patient 18 years of age or less
* Unable to speak, read, and comprehend English
* Unwilling or incapable of providing informed consent
Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease

The current study will examine the use of a mobile electronic application used to deliver cognitive rehabilitation to patients with mild cognitive impairment due (MCI) due to Alzheimer's disease (AD), and patients with mild AD. Patients will be given a specific cognitive rehabilitation program on their mobile device (iPad) with specific tasks for them to complete. The goal of this study is to determine if a) patients are able to use and adhere to a cognitive rehabilitation program delivered to their mobile device and b) to determine if patients can improve their language, attention, and memory by completing cognitive rehabilitation tasks assigned to them.

In the current study, the investigators are examining the use of a mobile electronic application used to deliver cognitive rehabilitation tasks to patients with mild cognitive impairment due to Alzheimer's disease, and patients with mild Alzheimer's disease. An estimated 100 patients will be enrolled into the study (\~50 patients with mild cognitive impairment, \~50 patients with Alzheimer's disease).

Participants will either receive memory tasks designed to help stabilize or improve memory (Intervention Group) or a set of word or math puzzles (Control Group). Participants will complete memory tasks or puzzles for a six month period. The investigators will conduct pre- and post- neuropsychological testing to assess changes in cognitive status (e.g., memory, language, executive functioning) in the intervention group. Neuropsychological tests assessing changes to cognition will be completed prior to participant assignment to the Intervention or Control Group. Both groups will then be assessed again using neuropsychological tests. The investigators will also assess changes in performance on cognitive rehabilitation tests over the six month period to determine the efficacy of these tasks.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of mild cognitive impairment due to Alzheimer's disease (MCI due to AD) by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association criteria (Albert et al., 2011).
* A diagnosis of mild Alzheimer's disease by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association criteria (McKhann et al., 2011).
* 50-90 years of age.

Exclusion Criteria:

* Younger than the age of 50 or older than the age of 90.
* Any self-reported history of substance abuse or alcohol abuse.
* Any self-reported history of prior head trauma (e.g., stroke, traumatic brain injury)
* Any prior self-reported history of significant depression or other mood disorder.
Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884

A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers

This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for a total of 56 healthy subjects. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and follow up visits. The number of follow up visits depend on the cohort assigned.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18-55 years
* Must provide written informed consent
* Ability and willingness to adhere to the protocol
* BMI 18-30kg/m2
* Females not of childbearing potential
* Males must practice 2 effective contraceptive measures if sexually active
* Japanese descent for the Japanese cohort

Exclusion Criteria:

* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
* History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Abnormal lab values, physical exam, vital signs
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
* Positive Hepatitis B, Hepatitis C or HIV test
* Receipt of investigational therapy with 4 months from screening
* Current or previous use of systemic corticosteroids 60 days prior to dosing or lipid lowering medications 28 days prior to dosing
* Abnormal ECG
* Recent plasma or blood donation
* Positive drug or alcohol screen.
* Current smoker
Trends Over Time (1990-2010) of Diarrhoea-related Incidence, Hospitalizations and Deaths in Children of Panama

This study aims at collecting data from secondary sources to obtain baseline incidence and monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis related hospital discharges and gastroenteritis related deaths in children \< 5 years of age in Panama before and after implementation of Rotarix™ universal mass vaccination.

Data will be collected from systematic review of the databases of epidemiologic surveillance system, hospital discharges and deaths for all cause gastroenteritis related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diarrhea cases, diarrhea associated hospital discharges, and diarrhea related deaths occurring in children \<5 years of age during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, in the mortality database of the Contraloría General de la República and in the hospital discharge records of the selected hospitals, will be collected for the study.

Exclusion Criteria:

* Not applicable
Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy

This is a study investigating the effect of MEDI7352 on chronic pain in participants with painful diabetic neuropathy.

The study incudes a screening period of up to 45 days and a 12-week treatment period during which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each dose separated by 14 days. There will be a 6-week follow-up period.

Participants will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo.


Eligibility Criteria:
Key Inclusion criteria:

* Male, or postmenopausal or surgically sterile female, 18 to 80 years of age
* Body mass index of ≤ 42 kg/m\^2.
* Chronic painful diabetic neuropathy (PDN) persistent for 6 months or longer, not adequately controlled by standard of care treatments.
* Mean pain intensity score of ≥ 4, as measured on an 11-point (0-10) numerical rating scale (NRS).
* Willing and able to discontinue all non-steroidal anti-inflammatory drug (NSAID) or cyclooxygenase-2 (COX-2) analgesic therapy.
* Currently be taking medication for the treatment of PDN. Participants should be taking at least one of the first-line medications (consistent with regional or local standard of care guidelines for PDN).

Key Exclusion criteria:

* Presence of other clinically significant neuropathy (eg, hereditary neuropathy, inflammatory neuropathy) or other clinically significant disorder (eg, nerve compression injury) involving abnormal peripheral sensation, with an aetiology that is considered to be distinct from that of PDN, and that is likely to interfere with assessment of peripheral nerve function, as judged by the investigator.
* History of osteonecrosis, rapidly progressing osteoarthritis (OA), subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy.
* Diagnosis of clinically significant OA currently affecting a major joint in the upper extremity (shoulder, elbow, or wrist) or lower extremity (hip, knee, or ankle) or axial spine; or other degenerative disease affecting any joint in participants for whom, in the opinion of the investigator, there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy.
* Chronic pain condition, other than PDN, that is likely to interfere with the evaluation of the participant's PDN pain, as judged by the investigator.
* Haemoglobin A1C greater than 10.0% (\> 10.0%).
COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2

This is a national multicentre observational study with retrospective and prospective data collection to assess the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies.

The subjects enrolled will be patients with early infection of SARS-CoV-2, paucisymptomatic, with risk factors for evolution to the severe form (according to AIFA criteria). Also, hospitalised subjects will be enrolled to receive SARS-CoV-2 monoclonal antibodies because of negative serology (according to AIFA criteria).

It is estimated to enrol about 1000 subjects.

Patients will be evaluated at enrollment and 28 days following administration to collect data on symptoms, possible hospitalization and final clinical outcome (alive with symptoms, alive without symptoms, alive with symptoms and hospitalized or deceased).

Data will be collected using a dedicated electronic Case Report Form (eCRF).


Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years
* Confirmed diagnosis of SARS-CoV-2 infection
* Having received or receiving any anti-SARS-CoV-2 monoclonal antibody (or combination of monoclonal antibodies) prescribed through the AIFA registry
* Signature of informed consent (for subjects enrolled in the prospective part)

Exclusion Criteria:

* Absence of criteria for prescribing monoclonal antibodies as determined by AIFA
* Patients already hospitalised for non-COVID reason at the time of monoclonal antibody administration