cyrilzakka/clinical-trials huggingface dataset:
Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

The investigation will be conducted as the addtional pharmacovigilance activitiy specified in the Japan Risk Management Plan (J-RMP) of Evusheld in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act).

Eligibility Criteria:
Inclusion Criteria:

* For treatment of symptomatic disease caused by SARS-CoV-2 infection; Patients with risk factors for severe SARS-CoV-2 infection who do not require supplemental oxygen.
* For prevention of symptomatic disease caused by SARS-CoV-2 infection; Individuals for whom SARS-CoV-2 vaccination is not recommended OR those who are considered to have an inadequate response to a COVID-19 vaccine due to immunodeficiencies AND who is not close contacts such as family members or other people living in the same dwelling as patients infected with SARS-CoV-2.

Exclusion Criteria:

* None
Effects of Breathing Exercises in Women With Chronic Pelvic Pain

The primary cause of the complex interaction of chronic pelvic pain originates from the visceral organs in the pelvic cavity, and it has been observed that musculoskeletal dysfunctions (such as increased muscle activity in the pelvic floor muscles) are often accompanied by visceral painful stimuli in the pelvic region as a result of shared innervation and visceral-somatic convergence.

This study aims to investigate the effect of breathing exercises combined with pelvic floor exercises on pain, pelvic floor muscle activity, psychological factors, and quality of life in women with chronic pelvic pain.


Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with chronic pelvic pain (CPA)
* Having pelvic pain for at least 6 months
* 18-45 years old
* Having high resting activity of the pelvic floor (\>2 microvolts based on superficial EMG (sEMG) readings)

Exclusion Criteria:

* Having a history of pelvic cancer and/or surgery
* Receiving radiotherapy and/or chemotherapy
* Having a neurological and/or psychiatric pathology
* Have a urinary tract infection
* Menopause
* Presence of current pregnancy status
* History of miscarriage and ectopic pregnancy
* Presence of prolapse
* Being \>30 kg/cm2 according to body mass index (BMI)
* Have received treatment for the pelvic area including manual therapy and electrotherapy in the last 6 months
* Having had botulinum toxin injections in the pelvic region in the last 6 months
* Having a communication problem
Training for Men Undergoing Androgen Deprivation Therapy.

The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy (ADT).

The main questions it aims to answer are:

* How feasible and safe is the new training concept?
* How efficient is the training concept to counteract side effects caused by ADT?

Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects.

Participants in the intervention group will perform the new training concept twice weekly for 12 weeks. Participants in the control group will only receive usual care. All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes.

Detailed description of the training concept applied in the intervention:

The two weekly training sessions will be separated by at least two days and supervised by appropriately trained exercise professionals at The Swedish School of Sport and Health Sciences. The training includes a 10 min warm-up followed by 3-4 sets of 8 maximal repetitions on the flywheel machine followed by 16-24, 20 s intervals on a Monark cycle ergometer. The intervals will be performed as 3 blocks with the intention to execute 8 intervals in each block. When a participant manages to perform all 3 blocks with 8 intervals in each block (a total of 24 intervals) the resistance will be increased by \~20 W. The rest period between the intervals will be set to 10 s and the rest between the blocks to 2 min. The starting workload of the intervals will be individually adjusted to \~115 % of the participant's power output at VO2peak. The total duration of a training session will be 30-40 min (including worm-up).

Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent
2. histologically confirmed localised or locally advanced prostate cancer
3. planned radiotherapy in combination with ADT for at least six months (unfavorable intermediate risk and high-risk prostate cancer) with curative intent and with no known metastasis.

Exclusion Criteria:

1. very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone
2. localized prostate cancer planned for radiotherapy without ADT
3. on-going or previously treated with ADT or other hormonal treatments
4. have any contraindications to physical testing/exercise as per the ACSM guidelines
5. unable to comply with study procedures
Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency

The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.

Syntropin will be administered by subcutaneous injection. Eligible patients will receive a subcutaneous injection of octreodite (to suppress endogenous growth hormone secretion) 12 hours before, immediately prior to, and 12 hours after the scheduled injection of growth hormone.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 18 and 45 years (inclusive).
* Written informed consent to participate in the study.
* Body mass index between 19 and 31 kg/m².
* Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from 3 months prior through 7 days following the last dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum). Subjects must have used the same method for at least 3 months prior to starting the study.
* No clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results during screening.
* Screening growth hormone and insulin-like growth factor I (IGF-I) within normal limits.

Exclusion Criteria

* A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principle Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
* A history of allergic or adverse responses to growth hormone, glycerin, or metacresol, or any comparable or similar product.
* Subjects who (for whatever reason) have been on an abnormal diet during the four weeks preceding the study.
* Subjects who donated blood within 30 days or plasma within 14 days of the first study dosing.
* Participation in a clinical trial within 30 days prior to study initiation.
* Use of any over-the-counter (OTC) medication, including vitamins, within 7 days prior to or during the study.
* Use of any prescription medication within 14 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential.
* Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to or during the study.
* Smoking or use of tobacco products within 6 months prior to or during the study.
* Female subjects who are trying to conceive, are pregnant, or are lactating.
* Positive serum pregnancy test at screening or urine pregnancy test prior to each drug administration for all women regardless of childbearing potential.
* Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol or drugs of abuse.
Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy

To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years old.
* Patients with metastatic colorectal cancer (CRC).
* Patients must have sufficient and obtainable tumor tissue for biomarker analysis from original surgical resection.
* Patients with documented disease progression within 6 months of their most recent dose of chemotherapeutic regimens.
* Patients with at least one measurable lesion.
* Adequate bone marrow function.
* Adequate liver function.
* Adequate renal function.
* Patients with a life expectancy of \> 3 months.
* Patients with a World Health Organization (WHO) performance status of 0, 1, or 2.
* Women of childbearing potential must have had a negative serum pregnancy test 72 hours prior to the administration of the first study treatment.
* Patients who give a written informed consent obtained according to local guidelines.

Exclusion criteria:

* Patients currently receiving anti-cancer agents or who have received these within 4 weeks prior to study entry.
* Patients who have previously received RAD001.
* Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
* Chronic treatment with steroids or another immunosuppressive agent.
* Patients with untreated central nervous system (CNS) metastases or neurologically unstable CNS metastases.
* HIV seropositivity.
* Patients with an active, bleeding diathesis. Patients may use enoxaparin.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
* Patients who have a history of another primary malignancy \< 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
* Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment.
* Patients unwilling to or unable to comply with the protocol.

Other protocol defined inclusion/exclusion criteria may apply
Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment

To describe the direct costs related to warfarin/apixaban treatment

To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-valvular atrial fibrillation (NVAF);
* New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
* Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
* Apixaban arm: genetically determined higher sensitivity to warfarin;
* Patients whose status allowed oral treatment with apixaban/warfarin;
* Age ≥ 18;
* Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.

Exclusion Criteria:

* Diagnosis of valvular disease;
* Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
* Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
* Contraindications according SmPC of Eliquis
Mental Processes for Rating Pain Intensity

This new study builds on the principal investigator's earlier studies to improve communication about pain. The research team seeks to better understanding of the mental processes needed to rate pain.


Eligibility Criteria:
General inclusion criteria:

* 18 years old or older;
* visited a HCP for treatment of a painful musculoskeletal condition within previous year;
* has usually felt, at least, "mild" musculoskeletal pain on most days of the last 3 months in multiple locations; and
* has felt variable musculoskeletal pain intensity during the last 3 months.

General exclusion criteria:

* past or current employment as a licensed healthcare provider;
* diagnosed with a cardiac arrhythmia;
* has a battery-powered implant in the neck, chest, abdomen, or spine (e.g., pacemaker);
* diagnosed with a neurological condition that causes uncontrolled movement (e.g., Parkinsonism, epilepsy, etc.);
* smokes cigarettes or vapes; (6) has abused substances during the last week; or
* allergic to skin adhesives.
Follow-up of Apneic Patients by Visio-consultation

Prospective multicenter open-label randomized clinical trial comparing videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .

The annual management of Obstructive Sleep Apnea (OSA) patients treated by continuous positive air pressure (CPAP) aims to maintain an optimal level of care while offering to the patients a combined management of their pathology. This management aims to reduce the risk of cardio-metabolic pathologies.

However, the high prevalence of OSA in the general population reduces the ability to explore undiagnosed patients. The contribution of videoconsultation is now available and allows the management of OSA patients treated by CPAP.

The objective of this study is to compare the videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .

The results of this study could provide very important new data on the impact of videoconsultation on the monitoring a chronic respiratory pathology such as sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* Apneic patient treated with CPAP for more than 12 months and having an annual scheduled follow-up visit.
* Adult patient who can give an informed consent.
* Patient with access to a media (Smartphone, tablet or computer) and an Internet connection at home.

Exclusion Criteria:

* Patient unable to use or understand the digital system.
* Patient under guardianship or deprived of liberty
* Pregnant woman
* Patient in a period of exclusion from another clinical trial
Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies

The purpose of this study is to develop simple diagnostic screeningtests and investigate potential biomarkers for identifying patients with abnormalities of mitochondrial function, which also can be used as outcome measures in future clinical trials. The study will investigate two submaximal tests: a submaximal handgrip test and a walking test. Furthermore investigators will investigate Acyl-carnitine profiles and GDF-15 levels in patients with mitochondrial myopathy.


Eligibility Criteria:
Inclusion Criteria:

* age 18-75
* verified mitochondrial myopathy
* or healthy control
* or disease control (another neuromuscular disease)

Exclusion Criteria:

* Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
* Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction
* Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments.
* Pregnancy or breastfeeding.
An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors

The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Has small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer
* Has UGT1A1 genotype \*1/\*6, \*1/\*28, \*6/\*6, \*28/\*28 and \*6/\*28
* Is receiving CPT-11 plus platinum analogue (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)

Exclusion Criteria:

* Has contraindication for CPT-11
* Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4
Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]

The purpose of this survey is to evaluate the safety (that is, frequency of adverse events) and efficacy (that is, hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg ) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.

This survey was designed to evaluate the safety (that is, frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 mg (Takepron Intravenous 30 mg) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.

For adults, 30 mg of lansoprazole is typically mixed in physiological saline (JP) or 5 percent (%) glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

Participants with the following diseases for whom oral administration is not feasible:

Acute stress ulcer, and acute gastric mucosal lesions (both of which should be accompanied by bleeding).

Exclusion Criteria:

-
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial

Fluid responsiveness is difficult to assess at the bedside. The accuracy of published techniques to detect preload-dependent patients have many pitfalls and limitations. The present study test the role of noninvasive effective pulmonary blood flow measured by expired carbon dioxide to detect fluid responsivess in mechanically ventilated patients.

This is a prospective and observational study designed to test the accuracy of the non-invasive effective pulmonary blood flow measured by the capnodynamic methodology for detect preload-dependent patients.

Fourty patients undergoing mechanical ventilation during surgery will be studied. Preload-depency (fluid responsiveness) will be tested during an increase in end-expiratory pressure (PEEP) from 5 to 10 cmH2O during one minute. Pulse pressure variation will be use as the reference method to detect preload-dependency. The effective pulmonary blood flow will be continuously recorded during the PEEP maneuver. Receiver Operator Curves will be used to detect fluid responsiveness taking a pulse pressure variation higher than 13%.The corresponding cut off value for the effective pulmonary blood flow signal will be determined..

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Programmed cardiac and noncardiac surgeries
* Need of invasive arterial blood pressure monitoring.

Exclusion Criteria:

* Emergency surgeries.
* Acute pulmonary diseases
* Arrhytmias
* Congestive cardiac failure
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.


Eligibility Criteria:
Inclusion Criteria:

- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Exclusion Criteria:

* Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.