cyrilzakka/clinical-trials huggingface dataset:
Post-Marketing Surveillance of Lenvima in Korean Patients

The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of Lenvima (lenvatinib) in normal clinical practice setting.


Eligibility Criteria:
Inclusion criteria:

Participants who meet the following criteria will be eligible for inclusion in the study:

1. Participants with approved indication for lenvatinib in Korea
2. Participants who have written consent for use of personal and medical information for the study purpose

Exclusion Criteria:

Investigators will refer to approved indications and contraindications regarding exclusion criteria
Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)

The aim of this study is to evaluate the effect and safety of Floseal in this preliminary prospective trial with patients undergoing acute laparoscopic cholecystectomy for acute cholecystitis


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 - 65
* Clinical (pain, fever \> 37.5 °C, WBC \> 10.000 / microL), and ultrasound evidence of cholecystitis
* Surgical indication for laparoscopic cholecystectomy
* ASA class I-III
* Informed consent
* \<72 hours from onset of symptoms

Exclusion Criteria:

* Informed consent refusal
* Choledocholithiasis
* Pre surgical generalized peritonitis (clinical evaluation)
* ASA class \> III
* Peripheral artery disease
* Active or past history of malignant systemic disease
* Pregnant or lactating females
* Known allergy to components Floseal including bovine allergy (bovine gelatin)
* Known drug or alcohol abuse
* Patients with known diabetes, chronic renal disease and other metabolic diseases
* Patients in chronic cortisone treatment more than 2 years before surgery
* Patients on chronic use of platelet inhibitors such as Aspirin, Plavix, NSAID's etc.
Inferior Vena Cava Diameter and Postpartum Hemorrhage

Excessive bleeding after normal birth or cesarean section is defined as blood loss of 1000 mL or more (clinically estimated) within 24 hours after birth. It occurs in about 5% among postpartum women. Postpartum hemorrhage is a leading cause of morbidity and mortality among women giving birth. Postpartum hemorrhage may lead to hemorrhagic shock, renal failure, respiratory failure, need for surgical intervention, blood transfusion and hysterectomy.

The cornerstone of effective treatment is rapid diagnosis and intervention in time. However, in a number of cases there is an underestimation of the volume of blood loss which may lead to delay in diagnosis and treatment. The consequences are even graver in women who delivered by a cesarean section, since unlike a normal birth in which the bleeding is external and visible, the bleeding is usually intra-abdominal, and so the delay in diagnosis may be even longer.

The Inferior Vena Cava (IVC) is a flexible blood vessel sensitive to intravascular blood volume, and its diameter varies accordingly. Its diameter reflects the pressure in the right atrium, which is a measure of the cardiac preload. A number of studies have shown that the IVC diameter changes, before the variations in vital and clinical signs.

Recently, IVC diameter has been assessed as an assessment of intravenous fluid balance in hemodynamically stable patients with a risk of sub-volume shock. The authors concluded that the IVC measurement is a good noninvasive method, compared to catheter insertion into the right atrium, and it is available as a bedside procedure.

In obstetrics the use of IVC to determine blood loos was not widely examined and there is no information regarding the use of IVC diameter as a predictor or as a detection method of postpartum bleeding.

In this study the investigators aim to examine the correlation between IVC diameter and the volume of postpartum blood loss.


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 after birth
* Single pregnancy
* Vaginal birth
* Term pregnancy (gestational age between week 37-42)
* The newborn is appropriate for gestational age (10-90 percentile)

Exclusion Criteria:

* Gestational or pre-pregnancy hypertension
* Heart, liver, or chronic kidney disease
* Women who delivered newborn with major malformation
Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function in the Functional Capacity of Older Adults

The population is increasingly older and this means that there are more and more dependent older people, for this reason it is necessary to achieve the best quality of life for the older adult population by promoting active and healthy aging.


Eligibility Criteria:
Inclusion Criteria:

* Have a mild dependency according to the Barthel Index (score greater than 60 points).
* Not present serious cognitive impairment, nor serious psychiatric or somatic disorders, nor disruptive and inappropriate behaviors.
* Be able to understand each of the self-administered questionnaires and perform the tests.

Exclusion Criteria:

* Have vision problems.
* Be enrolled in a physical exercise program.
The Individual Response of Healthy Individuals to Mental Fatigue

The objective of the present study is to confirm and map out the presence of interindividual differences in the effect of mental fatigue on both physical and cognitive performance, and to see if these differences are related to individual factors of the participants.

Every participant will visit the lab a total of three times within a period of two weeks. In the first visit, they will undergo both a detailed screening as well as perform all intervention/control trial measures to familiarize themselves with the utilised equipment. This detailed screening entails, among other things, a maximal incremental exercise test, a cognitive test battery and multiple subjective questionnaires.

The experimental and control trial are almost identical, with the only difference being the task performed in the middel of the trial. At the beginning of the trial the EEG will be fitted to the head of the participant and baseline measures will be taken. Afterwards, participants will perform a go nogo task to assess baseline cognitive performance. Then the intervention (i.e. Stroop task) or control (i.e. documentary) task will be performed. The goal of the Stroop task is to elicit mental fatigue, while the documentary provides a meaningful comparison. Afterwards, cognitive performance will again be assessed using the go no go task, followed by a physical performance task in the form of a time trial.

The different internal factors assessed during the screening stage will be correlated to the difference in cognitive and physical performance between the intervention and control trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (No neurological, cardiovascular or musculoskeletal disorders of any kind)
* No prior knowledge of the concept of mental fatigue
* No medication
* Non-smoker

Exclusion Criteria:

* Injuries of any kind in the past 6 months
* Suffering from a chronic health condition (could be neurological, cardiovascular, internal and musculoskeletal)
* Participating in any concomitant care or research trials
* History of suffering from any mental/psychiatric disorders
* Suffering from a higher risk of burn out, indicated by a total score of ≥ 2.59 on the Burn out assessment tool (BAT)
* Suffering from high general fatigue, indicated by a score of \>59 on the Multidimensional fatigue inventory (MFI)
* Suffering from depression, indicated by a score of \>16 on the Beck depression inventory-II (BDI-II)
* Use of medication
* Use of caffeine and heavy efforts 24 hours prior each trial
* Suffering from colour vision deficiencies
* Not eating a standardized meal, the morning of each trial
Effect of Gentamicin Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume

The effect of axillary lavage with a gentamicin solution before wound closure will reduce the drainage volume and subsequently day of drainage removal.

Inclusion criteria will be a diagnosis of mammary neoplasms and plans to undergo an elective ALND of Berg´s levels I and II due to axillary metastasis determined preoperatively by core biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed analysis. Exclusion criteria will be chronic renal failure due to possible toxicity of gentamicin and patients undergoing a modified radical mastectomy.

The patients will be randomized by means of an Internet randomization module into 2 groups: those patients undergoing 2 lavages of the axillary surgical bed with normal saline (Group 1) and those ones first undergoing lavage with normal saline followed by a second lavage with a gentamicin solution (Group 2).

Surgical dissection will be performed using harmonic scalpel (Ultracision, Ethicon Endosurgery, Johnson and Johnson, Cincinnati, OH, USA). Once finished the ALND, a Jackson-Pratt drain will be left in place and connected to a low pressure vacuum device.

Methodology: Irrigation technique and extraction of microbiological samples:

The lavage will be performed immediately prior to closure of the wound, once placed the drainage into the cavity. In both groups, prior to the lavage, a microbiological sample from the surgical bed will be obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline. After aspiration of the saline, a new microbiological sample will be obtained (sample 2). In Group 1 a second lavage with 500 ml normal saline will be performed, while in Group 2 the second lavage will be performed with an antibiotic solution, including gentamicin (240 mg) dissolved in 500 ml normal saline. After aspirating this second lavage, a third microbiological sample will be obtained in the same way as the two previous ones, in both groups (sample 3).

Indication of drain removal and obtention of sample 4:

After discharge, the patient will be asked to quantify the drainage volume daily. Drain will be removed when drainage volume was \<30 ml/day. The drainage volume of the last day was collected in a syringe for microbiological study (sample 4).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mammary neoplasms and plans to undergo an elective ALND of Berg´s levels I and II due to axillary metastasis determined preoperatively by core biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed analysis.

Exclusion Criteria:

* chronic renal failure due to possible toxicity of gentamicin
* patients undergoing a modified radical mastectomy.
Evaluation of the Reproducibility of a Fatigability Test Fitted to Patients With Spinal Muscular Atrophy

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease caused by the degeneration of motor neurons in the anterior horn of the spinal cord, due to the absence of the SMN1 gene and the resulting lack of SMN protein. Some patients with particularly severe forms (types 0 or 1) die before the age of 2 in the absence of treatment, while others retain autonomous walking throughout their lives, with no reduction in life expectancy. Three treatments aimed at restoring SMN (TRS) protein expression have recently been approved by the US Food and Drug Administration and the European Medicines Agency (i.e. Nusinersen / Onasemnogene Abeparvovec / Risdiplam). Patients treated with TRS after the onset of symptoms (symptomatic patients) may show significant motor improvement, but retain difficulties such as muscle weakness and fatigue leading to limitations in activities of daily living. The aim of this study is to adapt a fatigability test, widely validated in its original version in different populations (QIF test), but adapted in this protocol to the motor level and low abilities of certain SMA patients. Our objectives are to determine whether these assessments are feasible in SMA patients, reproducible, and relevant for monitoring this population, either routinely or for future clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed spinal muscular atrophy
* Age ≥ 6 years
* No orthopaedic surgery in the 6 months prior to inclusion
* Informed consent signed by the patient(s) or parent(s)/legal guardian(s) and assent of the patient
* Affiliated or beneficiary of a health insurance scheme (for inclusion in France)

Exclusion Criteria:

* Other condition that may significantly interfere with the assessment of the SMA and which is clearly unrelated to the disease
* Other associated neurological disease
* Joint deformities that prevent correct and comfortable positioning with the various different measuring devices (thumb-index clamp, handgrip and QIF-test)
* Contraindication to transcranial magnetic stimulation
A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated

The objective of this trial is to investigate the safety, tolerability and pharmacokinetics of BI 894416 in healthy Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history, including a medical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
2. Japanese ethnicity, according to the following criteria:

   - born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
3. Age of 20 to 45 years (inclusive) at screening
4. BMI of 18.5 to 25.0 kg/m2 (inclusive) at screening
5. Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation
6. Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication

   * Use of adequate contraception, any of the following methods plus condom:

intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration

* Vasectomized (vasectomy at least 1 year prior to enrolment)
* Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication, except appendectomy or simple hernia repair
7. Diseases of the central nervous system, including but not limited to, any kind of seizures or stroke, and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Response Of Metabolic Syndrome Severity Score To High Intenisty Interval Training In Women With Central Obesity.

This study will be conducted to investigate any significant effect of high intensity interval training on metabolic syndrome severity score in women with central obesity.

RESPONSE OF METABOLIC SYNDROME SEVERITY SCORE TO HIGH INTENISTY INTERVAL TRAINING IN WOMEN WITH CENTRAL OBESITY

forty eight women with age ranges from 25 to 45 years old will be selected from nutrition-outpatient clinic; they will participate in the study for 6 weeks, and randomly be assigned into two equal groups.

Study group A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 6 weeks , study group B (n =24) will receive caloric restriction diet

For evaluation Physical efficiency index using Modified Harvard Step test It is a powerful indicator for aerobic fitness. The Fitness Index score is determined according to the following equation

Fitness Index (long form) = (100 x test duration in seconds) divided by (2 x sum of heart beats in the recovery periods).

Metabolic syndrome severity score Metabolic syndrome severity score will be calculated through MetS Calculator (MetSCalc).

-3Laboratory investigation before \& after treatment: for fasting blood glucose level and Lipid profile (total cholesterol, LDL, HDL, TAGs).

4- The 45-item Diet Satisfaction Questionnaire (DSat-45)

B) For treatment

1- Grand II Treadmill: (AC999- for maximum weight 150 Kg-

Eligibility Criteria:
Inclusion Criteria:

- 1. 48 Women subjects with age ranges from 25to 45 years.

2. Waist height ratio ranges from 49-58 (overweight and seriously overweight).

Exclusion Criteria:

* 1. Uncontrolled Diabetes 2. Uncontrolled hypertension 3. Cognitive impaired patients 4. Severe Anemic women 5. Subjects with physical or musculoskeletal disabilities 6. Pregnancy 7. Recent cardiothoracic surgery
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)

This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.


Eligibility Criteria:
Inclusion Criteria:

* The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration.
* Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).
* Has at least one reliable and consistent parent, legal guardian, or caregiver during the study.
* The participant or legal representative must be willing and able to provide written informed consent
* The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.

Exclusion Criteria:

* The participant is receiving exclusionary medications.
* Current use of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing ≥50% Delta-9-tetrahydrocannabinol (THC).
* The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia) pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
* The participant is unable or unwilling to comply with any of the study requirements or timelines.
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile

The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.

Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy individual into the gastrointestinal tract of the patient. This has been done in the past for recurrent colitis secondary to Clostridium difficile infection (CDI) using different methods such as through nasogastric tube, fecal retention enemas, and by colonoscopy. This method of treatment was introduced over 50 years ago with high success rates, although it has not been until recent that more case studies have been performed, with continued success rates of approximately 90%. Studies have found this therapy to be effective with resolution of symptoms in most patients, and have found it to be both cost effective and safe.

The purpose of this study is to use a standardized published protocol for fecal microbiota transplantation performed by colonoscopy and record the success rate and outcomes of FMT therapy for patients with recurrent CDI at the UMassMemorial Medical Center. In addition, the cost of this therapy will be compared to conventional antibiotic treatment. The reduction in hospitalizations will also be monitored compared with historical controls.

The hypothesis of this study is that FMT therapy will show resolution of infection in most patients with recurrent CDI, with an overall reduction in cost to the hospital for recurrent admissions for Clostridium difficile colitis as compared to historical controls. Historical controls will be defined as patients with recurrent positive Clostridium difficile stool samples treated in the traditional fashion with antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.
* Failed standard therapy with oral metronidazole and/or oral vancomycin
* One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity

Exclusion criteria:

* Age \<16 years old
* patients with acute severe colonic dilation at risk for colonic perforation