cyrilzakka/clinical-trials huggingface dataset:
Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period

This study will test the well-known medicine turoctocog alfa for any side effects. The purpose is to test turoctocog alfa for any side effects in the Indian population. The participants will get turoctocog alfa. Turoctocog alfa is already a well-known medicine in India, and can be prescribed by the study doctor. The participants will get an injection every second day or 3 times per week. This is decided by the study doctor. The study doctor will decide the amount and how often the participants must take the medicine. The study will last for about 16 weeks. The participants will have 5 visits with the study doctor. If the participants agree to participate in this study, the participants will receive the first injection at the second visit, thereafter the participants will be trained to do the injection by themself.


Eligibility Criteria:
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male, age above or equal to 12 years at the time of signing informed consent - Patients with the diagnosis of congenital moderate or severe Haemophilia A based on medical records. (FVIII below or equal to 5%) - Documented history of at least 150 EDs (exposure days) to FVIII containing products Exclusion Criteria: - Confirmed inhibitors to FVIII (above or equal to 0.6 BU) at screening as assessed by central laboratory - History of FVIII inhibitors - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 1 month before screening (visit 1) - Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol - Immunocompromised patients due to HIV infection (defined as viral load above or equal to 400.000 copies/mL and/or CD4+ lymphocyte count below or equal to 200/μL). HIV status and CD4+ lymphocyte count /viral load results may be obtained at screening or from available medical records; results must be not older than 6 months - Known congenital or acquired coagulation disorders other than haemophilia A - Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
Contingency Management to Promote Weight Loss in Low Income Adults

This study is designed to evaluate the feasibility and provide preliminary evidence for efficacy of a 12-week contingency management intervention to promote weight loss in overweight and obese low income adults in a community-based clinic. The study has three primary goals: (a) to determine if the contingency management treatment can be effectively applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency management's efficacy in promoting weight loss and improving treatment retention, diet quality, physical activity levels, and self efficacy; and (c) to identify barriers and challenges to implementing contingency management for weight loss among low income patients.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 55 years
* body mass index in kg/m2 (BMI) between 25 and 39.9
* resting blood pressure between 90/60 and 140/90
* ability to speak English and read at the 6th grade level
* willingness to be randomly assigned to one of two groups

Exclusion Criteria:

* any serious acute or chronic medical problems that may impact dietary or exercise regimens
* psychiatric conditions
Effects on Septic Patient's Microcirculation of the Transfusion of Different Types of Concentrated RBCs.

Aim of the study is to evaluate the effects, on microcirculation of septic patient, of three types of RBCs: 1- fresh standard RBCs (storage \<10 days); 2-leukodepleted RBCs and 3-old standard RBCs (storage \>15 days) respectively. Before and 1 hour after the transfusion, microcirculation is evaluated using Sidestream Dark Field Imaging (SDF) and Near InfraRed Spectroscopy (NIRS) with vascular occlusion test. We also monitor temperature, heart rate, mean blood pressure, hemochrome, blood gases, blood lactates and SOFA score.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sepsis, severe sepsis or septic shock who, according to clinical evaluation, need a hemotransfusion.

Exclusion Criteria:

* Patients under 18 years of age; Pregnancy; Coagulative disorders; Cardiogenic shock (Met\<4;)Acute massive bleeding (\>8 U)
Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO

Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.

bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.

Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.

Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.

Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. Prostate cancer is the most common non-cutaneous cancer in men internationally, and more than 90% of patients with hormone-resistant prostate cancer will have bone metastases.

They frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.

Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.

There is therefore a need for bone-targeting therapeutic agents that provide a benefit in terms of survival.

Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.

This treatment appears to have fewer side effects than chemotherapy (and does not call into question subsequent chemotherapy) or that the currently available metabolic bone radiotherapy as well as better pain control and survival gain than the latter do not

Eligibility Criteria:
Inclusion Criteria:

All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.

Exclusion Criteria:

Patients expressing a refusal to use this research data
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

This was a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study for an individual patient was 2.5 years.

Eligible patients were randomized to receive either experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. The dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at Day 1, Day 7 and Day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks starting at Week 4. In order to blind for the different formulations, double-dummy masking was used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years of age
* Diagnosis of multiple sclerosis (MS)
* Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
* At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year
* Expanded disability status scale (EDSS) score of 0 to 5.5

Exclusion Criteria:

* Primary progressive MS
* Disease duration of more than 10 years in patients with an EDSS score of 2 or less
* Patients with an active chronic disease of the immune system other than MS
* Patients at risk of developing or having reactivation of hepatitis
* Patients with active systemic infections or with neurological findings consistent with PML
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.


Eligibility Criteria:
Inclusion Criteria:

* Patient with thickened endometrium
* Abnormal uterine bleeding

Exclusion Criteria:

* Pregnant
* Active pelvic infection
* Pelvic inflammatory disease
* Blood clotting disorders
* Sexually transmitted disease
* Uterine perforation
* Recent cesarean section
Cormet Post-PMA Study: New Enrollment

The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient who meets eligibility criteria consistent with product labeling
* skeletally mature
* mentally capable of completing follow-up forms
* Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation
* Has been deemed a candidate for hip replacement by diagnosis of the investigator
* consented to participate in the clinical study

Exclusion Criteria:

* Patient with active or suspected infection in or around the hip joint;
* Patient with bone stock inadequate to support the device
* Patient with severe osteopenia
* Patient with a family history of severe osteoporosis or severe osteopenia;
* Patient with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT Grade)
* Patient with multiple cysts of the femoral head (\>1cm)
* In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
* Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery;
* Female of child-bearing age due to unknown effects on the fetus of metal ion release.
* Patient with known moderate or severe renal insufficiency;
* Patient who is immunosuppressed with diseases such as AIDS or person receiving high doses of corticosteroids;
* Patient who is severely overweight;
* Patient with known or suspected metal sensitivity (e.g., jewelry).
SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.

The phase 1b/2,multicenter, open-label study, contains 2 parts.

Part 1 Dose Escalation of SC0191 combination chemotherapy:

Part 1 will estimate the RP2D in dose escalation cohorts in patients withadvanced ovarian cancer.

Part 2 Dose Expansion of SC0191 plus Chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced ovarian cancer that has failed or intolerant or not applicable to standard treatment (applicable to the dose escalation phase of stage Ib);
2. Histologically or cytologically confirmed advanced high-grade serous ovarian cancer, platinum-resistant or platinum-refractory recurrent ovarian cancer (applicable to the dose expansion phase of stage II);
3. There is at least one measurable lesion that meets the definition of RECIST 1.1;
4. Voluntarily participate in clinical trials and sign informed consent;
5. Age ≥18 years;
6. ECOG score of 0 to 1;
7. Predicted life expectancy ≥3 months;
8. Adequate bone marrow, liver biochemistry, renal function, and coagulation status.
9. Female patients who agree to use adequate contraceptive measures.

Exclusion Criteria:

1. Received chemotherapy, radiotherapy, immunotherapy or biological therapy, steroid therapy or other investigational drugs \<28 days prior to the first dose of study treatment.
2. Patients who have not fully recovered from surgery according to the investigator's judgment.;
3. Patients who have previously received WEE1 inhibitor treatment;
4. Unresolved AEs or toxicities due to previous treatments;
5. Patients with contraindications or a history of severe allergies to gemcitabine or paclitaxel;
6. Known malignant CNS disease other than neurologically stable, treated brain metastases;
7. Other medical conditions or systemic diseases not suitable to participate;
8. The need for long-term therapeutic doses of anticoagulant or antiplatelet drugs;
9. Received CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers within 14 days;
10. Pregnant or lactating women.
Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea

This is an explorative, proof-of-concept study exploring the potential therapeutic role of a Liraglutide-based weight loss regimen versus standard CPAP or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index in non-diabetic patients with moderate to severe obstructive sleep apnea


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed moderate-severe OSA (by standard PSG)
* Body mass index between 30 - 40
* Age 18 - 60 years
* Able to provide written, informed consent

Exclusion Criteria:

* Pregnancy
* Requirement for supplemental oxygen
* Previous diagnosis of OSA or previous CPAP treatment
* Diagnosis of Diabetes
* Previous treatment with GLP-1 analogue
* Previous surgical treatment for obesity
* Active treatment for malignancy or severe psychiatric disorder
* Acute coronary syndrome or stroke within 3 months prior to study
* History of decompensated heart failure
* Professional drivers or drivers with a history of road-traffic accident due to sleepiness
* Severe excessive daytime sleepiness defined as Epworth sleepiness scale \>15
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.

None provided

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 to 70 years.
* Stable dose of ursodeoxycholic acid (URSO, UDCA) for at least 6 months prior to screening.
* Female patients must be postmenopausal, surgically sterile, or prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of dosing.
* Male patients must be prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of the dosing.
* Proven or likely PBC, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors:

  1. History of increased AP levels for at least 6 months prior to Day 0
  2. Positive AMA titer (\>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
  3. Liver biopsy consistent with PBC.
* Screening AP value between 1.5 and 10 × ULN.

Exclusion Criteria:

* Administration of the following drugs at any time during the 3 months prior to screening for the study: colchicine, methotrexate, azathioprine, or systemic corticosteroids.
* Screening conjugated (direct) bilirubin \>2 × ULN.
* Screening ALT or AST \>5 × ULN.
* Screening serum creatinine \>1.5 mg/dL (133 mol/L).
* History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
* History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis (NASH).
* Pregnancy.
Nervous System Infections Among Patients With Febrile Seizure

Few studies dealing with the risk of infectious of nervous system and the utility of lumbar puncture and of emergent neuroimaging among patients with simple febrile seizure between 3 and 11 months age and with complex seizure has been reported. None of these studies was multicentric. Recommendations about management of these children are heterogeneous.

The investigators aim to study by an observational retrospective multicentric study the rate of infectious of central nervous system among patients with a complex febrile seizure and among patients between 3 and 11 months age with simple febrile seizure.


Eligibility Criteria:
Inclusion Criteria:

* febrile (\>38°)
* Seizure

Exclusion Criteria:

* previous non febrile seizure
* known trauma
* immunodeficiancy status
* Underlying illness
Evaluating a New Sensor That Measures the Health of the Retina in Normally-sighted Subjects

The primary purpose of this study is to evaluate the ability of a new contact lens electrode to record a measurable electroretinogram (ERG). ERG sensors in various forms have been in common clinical use for more than 50 years. The ERG sensor that is the subject of this study is the RM Electrode, developed by RetMap, Inc. (project sponsor). The subject of this study is the RM Electrode, a new ERG sensor developed by RetMap, Inc. The RM Electrode is not yet approved by the FDA. The testing described in this study has been requested by the FDA (pre-submission feedback) in support of the 510k application for the RM Electrode. ERG Jet Electrode (Fabrinal, Switzerland) will be used as the predicate device for comparison.

The first Aim of the present study is to compare the functionality of the RM Electrode and the ERG Jet. Following standard ERG test protocols, responses will be recorded from ten healthy (normally-sighted) adult subjects using both electrodes (used in random order). The signal quality of the ERG responses obtained from both contact lens electrodes will be compared. Signal quality will be determined by measuring ERG signal amplitudes and calculating signal-to-noise ratios (SNR). Signal-to-noise ratios will be used to establish substantial equivalence. ERG test results will not be used to determine the effect of the devices on the participants.

The second Aim of the present study is to evaluate the risk of ocular irritation caused by use of the RM Electrode compared to the ERG Jet Electrode. A typical ERG test session lasts 20 minutes. Ten healthy (normally-sighted) adult subjects will wear the RM Electrode on one eye and the ERG Jet Electrode on the other eye, for a total of 60 minutes, in 20-minute sessions with short breaks in between. To determine the effect of the devices on the participants, the eyes will be evaluated for irritation.


Eligibility Criteria:
Inclusion Criteria:

* Persons 18 and over.

Exclusion Criteria:

* Pregnant woman
* Individuals with existing diagnosis for any retinal disease, ocular surgery (including refractive surgery such as Lasik) within the past six months, corneal ulcers, or any noticeable ocular irritation on the study day.
* Non-English speaking persons may not enroll.
* Persons who may respond negatively to flashing lights in the eye will be excluded, or excused from the study if enrolled and the negative response is revealed during the study.

Excluded or Vulnerable Populations:

* No vulnerable populations are expected to enroll.
Assess Extent of Agreement Between Online 24-hr Dietary Recall and Interviewer-administered 24-hr Dietary Recall on the Same Day for 2 Non-consecutive 2 Days 1 wk Apart to Adults and School Age Children

Hypothesis: The online 24 hour dietary recall will be comparable to interviewer-administered 24 hour dietary recall considering the limits of agreement in the reporting of energy and macronutrient intake. If the two methods of dietary assessment are comparable (i.e., if greater than 95% of the data plots will lie within the limits of agreement), the online dietary assessment tool could be used in future studies to collect dietary intake data and health data in larger sets of Russian populations, in order to investigate the potential differences in anthropometric risk factors of non-communicable diseases (cancers, diabetes, obesity, hypertension, mortality, etc.) in people with different diet.

Baseline assessments include a demographic questionnaire, including anthropometrics (height, weight), a heath status questionnaire, supplement intake, eating habits, and a food frequency questionnaire, and cardiovascular assessment (blood pressure and heart rate).

Eligibility Criteria:
Inclusion Criteria:

1. Participants will be male and female.
2. 7-65 years of age.
3. Must be willing and able to record (via online questionnaire) the prior day's food intake according to the protocol.
4. Understanding of the procedures to be undertaken as part of the study.
5. Willingness to participate in research measurement and follow instructions provided by the investigator.
6. Informed, voluntary, written consent to participate in the study.

Exclusion Criteria:

1. Currently have any disease or condition that required chronic therapeutic nutritional treatment (the use of specific nutrition services to treat an illness, injury, or condition).
2. Currently dieting (currently on a diet to lose weight; currently on a diet for health reasons; currently on a diet to gain weight).
3. Have any formal training in nutrition, or had prior experience completing dietary recalls.
4. Participant is unable to complete computer-based dietary questionnaires, through a mental, physical or visual limitation that would preclude him/her from reporting their dietary intake.
Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

The primary objective is to evaluate the analgesic efficacy of PBK_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation
* Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure.

Exclusion Criteria:

* Participated in another oliceridine clinical study.
* Received any investigational drug, device or therapy within 35 days before surgery.
* Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study.
* American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.