cyrilzakka/clinical-trials huggingface dataset:
Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose

This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.


Eligibility Criteria:
Inclusion Criteria:

* A body mass index (BMI) in the range 18.0-30.0
* Ability \& willingness to provide written consent

Exclusion Criteria:

* Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
* History of bleeding disorders, coagulation variables or abnormal blood cell count.
* History of chronic illness.
* Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
* History of adverse reaction or allergy to any drug.
* Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication.
* History of drug or alcohol abuse
* Smoker or use of nicotine-containing products
* Blood pressure or heart rate at screening outside normal ranges.
Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit

The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled Analgesia pump will receive less morphine and experience fewer side effects than neonates receiving morphine via continuous opioid infusion.


Eligibility Criteria:
Inclusion Criteria:

* Surgery Location:

  * Abdominal or Thoracic
  * First surgery only

Age:

* Born ≥ 34-44 weeks post-menstrual age
* Weight: Weight at birth or current weight ≥2 kg Intubated or extubated

Prior opioid exposure:

* \< 2 days of continuous exposure
* if history of \> 2 day continuous exposure, must be off continuous drip for a week
* Intermittent exposure ≤ 2 days prior to surgery Neonates exposed to chronic opioids in utero \*In utero exposure to Selective Seretonin Reuptake Inhibitors and illicit drugs will be screened for and annotated.

At least 1 parent is English-speaking

Exclusion Criteria:

* Surgery Type:

  * Cardiac, Patent Ductus Arteriosus Ligation; Omphalocele (if intubated pre-operatively)

Diagnoses:

• Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating ventilator
Alster Stem Cells - Intramyocardial Stem Therapy

Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* LVDF \< 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
* conventional therapy according to the ESC guidelines for heart failure
* BMI \> 20 and \< 35

Exclusion Criteria:

* PCI elder then 21 days
* relevant valvular disease
* history of stroke/multivessel disease/thromboembolic event etc.
* DM Type I
* pregancy
Platelet-Directed Whole Blood Transfusion Strategy for Malaria

Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.

The PLATFORM trial is a single-center, open-label randomized controlled trial of whole blood transfusion for severe malaria complicated by thrombocytopenia. The trial will recruit 132 Zambian children 6 months to 15 years old with severe malaria defined according to modified WHO criteria with concomitant thrombocytopenia, defined here as a platelet count ≤75,000/uL, who do not otherwise have a current indication for transfusion according to current guidelines. Children will be randomized 1:1 to whole blood transfusion or no whole blood transfusion and followed to hospital discharge or death. The trial is nested within the Children and Adults with Severe Malaria (CHASM) cohort, a prospective observational study of severe malaria.

Eligibility Criteria:
Inclusion Criteria:

* Age \<5 years
* Platelet count ≤75,000/uL
* Hemoglobin \>5 and ≤9 g/dL
* P. falciparum parasitemia ≥500 parasites/uL
* Diagnosis of severe malaria meeting World Health Organization (WHO) criteria
* Ability and willingness of the legal guardian to comply with study protocol for the duration of the study
* Residence within health clinic catchment area
* Signed informed consent obtained from the parent or legal guardian of the participant

Exclusion Criteria:

* Residence in foster care or children otherwise under government supervision
* Residence outside the hospital catchment area, or plan to leave the area
* Presence of any other condition or abnormality which, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data
* Any contraindication to whole blood transfusion
Non-invasive Ventilator Modems: a Qualitative Study

Advances in technology has meant that domiciliary non-invasive (NIV) devices can be remotely monitored via modems in patients' homes. Possible benefits and challenges of modem technology have yet to be established. This study explored the perspectives and experiences of patients, their carers' and health care professionals (HCPs) on the addition of modem technology in managing home NIV patients.

The aim of this study is to consider the opinions of patients, their carers' and health care providers on the addition of using modem technology in the management of patients with hypercapnic respiratory failure receiving domiciliary NIV.

Objectives

1. To investigate the experience of patients receiving domiciliary NIV with modem technology and how this compares to NIV treatment without a modem
2. To investigate the experience of carers' of patients receiving domiciliary NIV with modem technology and how this compares to NIV treatment without a modem
3. To gain opinions of health care providers on the use of modem technology in caring for patient with ventilatory failure and how this compares to delivering home NIV treatment without a modem 4.2 Outcome The outcome of this study will inform future service development of home NIV services to ensure they are designed with service users' preferences in mind.

Eligibility Criteria:
Inclusion Criteria:

Patients and carers •Patients and their carers who received treatment from the Royal Free London (RFL) domiciliary NIV service both pre and post modem installation will be eligible to be included in the study.

HCPs

•Staff who have experience of looking after patients with NIV both with and without modems will be able to take part in the study. Staff recruited will be currently working at RFL. We have been using modems for all of our patients with NIV since December 2014. Therefore rotational staff (e.g. registrars) working RFL will only have experience of looking after patients with modems on their NIV. To allow for this factor staff will be allowed to join the study even if their experience of looking after patients with NIV without modems is at other hospitals.

Exclusion Criteria:

* Patients under the care of the RFL domiciliary NIV service who have only had experience of treatment with a modem in situ will be excluded from the study.
* Patients who are unable to verbally communicate
* Patients who cannot have an "everyday" level conversation in English
French Study to Highlight the Unmet Treatment Needs of 3L+ CP-CML and With T315I-mutated CML Patients

A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.

The index date for patients in the 3L cohort was defined as the date of initiation of 3L therapy. The index date for the T315I cohort was defined as the date of treatment initiation with TKI or allogeneic stem cell transplantation (allo-SCT) after identification of T315I mutation status. The baseline (i.e., pre-index) period was defined as the 6 months prior to the index date, and the post-index period was defined as the time from the index date to the date of last patient contact or patient death. Patients who were alive at the end of the follow-up period were censored at the date of last contact.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CML-CP
* Age ≥18 years at the time of CML-CP diagnosis
* For 3L patients: initiated one of the following 3L therapies in CML-CP after failing on ≥2 TKIs (i.e., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib) or allo-SCT
* For T315I mutation patients: evidence of T315I mutation and treatment with TKI or allo-SCT

Exclusion Criteria:

* History of other active malignancies within the 3 years prior to the time of CML-CP diagnosis
* Documentation of anti-cancer therapies for any other malignancies prior to the time of 3L therapy initiation or at the time of treatment initiation after identification of T315I mutation
* Enrollment in a clinical trial at the time of 3L therapy initiation or at the time of treatment initiation after identification of T315I mutation
Study of Hot Flashes and Night Sweats in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen

This pilot study was designed to explore the effects of combined treatment with raloxifene HCl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes plus night sweats) in postmenopausal women discontinuing continuous combined hormone replacement therapy (ccHRT) compared to women treated with raloxifene HCl 60 mg alone.


Eligibility Criteria:
Inclusion Criteria:

* Post menopausal women, 50-70 years of age
* Had taken ccHRT for at least 6 months prior to study entry
* No unexplained vaginal bleeding in the 3 months prior to study entry
* Understand and sign an informed consent document

Exclusion Criteria:

* Prior hysterectomy
* Endometrial thickness (excluding endometrial fluid) greater than 8 mm or endometrial fluid greater than or equal to 4 mm at study entry
* Abnormal Pap smear at study screening or within the preceding 3 years
* Abnormal transvaginal ultrasound result at study screening
* Past or current history of malignant neoplasms
The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs

this study was conducted the patients with rotator cuff tears who underwent rotator cuff repair surger.The patients were randomly divided into 2 groups and a total of 20 subjects were randomized in a single block order using RandomAllocation Software 1.0.0 by simple randomization.All evaluation and treatment was done by the same physiotherapist.The first group was included in the traditional treatment program after rotator cuff repair, while the second group was included in the myofascial release program, 2 sessions a week between the 4th and 7th weeks, in addition to the traditional treatment.

Patients in the 2 groups undergoing rc repair were also included in a similar physiotherapy program.Immobilization with a sling was made for 4-6 weeks after surgery. In addition to physiotherapy in group 2, myofascial release therapy was applied to the upper trapezius, sternocloidomastoideus, pectoral muscles (major, minor) 2 days a week between the 4th and 7th weeks after surgery, in addition to the conventional treatment. Myofascial treatment took 30-45 minutes per session.

Eligibility Criteria:
Inclusion Criteria:

* aged betweeen 18-65
* diagnosed with RC tear

Exclusion Criteria:

* wanting to leave the study
* not participating in assessments and/or treatments
* presence of massive tears
* accompanying nerve injuries,
* presence of labral lesion,
* diagnosed psychological problems,
* central nervous system problems
* those with any rheumatological and orthopedic diseases
* individuals who have had previous surgery on the same shoulder
Distinguishing Alcohol Intoxication, Cannabis Intoxication and Co-intoxication Using Electroencephalography (EEG)

This is a randomized, parallel-group study designed to explore the differences between cannabis intoxication, alcohol intoxication and co-intoxication involving both alcohol and cannabis, utilizing electroencephalography (EEG) as well as more traditional intoxication measures such as breath alcohol concentration and balance metrics. If eligible for the study, participants will be randomized to complete one study session in our mobile laboratory, during which they will use either alcohol, cannabis (which will be self-administered, ad libitum) or both alcohol and cannabis.


Eligibility Criteria:
Inclusion Criteria:

* 21-50 years old
* Heavy drinkers (consuming more than 4 drinks/day or more than 14 drinks/week for men, or more than 3 drinks/day or more than 7 drinks/week for women)
* Regular users of legal-market flower cannabis (at least 2x/week in past 3 months)
* report simultaneously using alcohol and legal-market flower cannabis at least once per month in the past 3 months
* English speakers.

Exclusion Criteria:

* Daily tobacco users
* Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD)
* Females cannot be pregnant, breastfeeding or trying to become pregnant
* Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders, 5) Current use of psychotropic (except anti-depressants)
* Report illicit drug use in past 60-days or fail drug screen on the day of the study appointment
* Major medical condition contraindicating alcohol and/or cannabis consumption.
Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder

OBJECTIVES:

I. Determine which treatment is most effective for patients with panic disorder: cognitive-behavioral therapy (CBT) plus imipramine (IMI), CBT plus placebo, CBT alone, IMI alone, or placebo alone.

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to receive one of five treatments: cognitive-behavioral therapy (CBT) alone, imipramine plus medical management (IMI), CBT plus IMI, pill placebo plus medical management (PLA), or CBT plus PLA.

Patients are seen by therapists for 11 sessions over 12 weeks (3 sessions during days 1-10 followed by 6 weekly sessions and 2 biweekly sessions). Each CBT session lasts approximately 1 hour, each IMI session lasts approximately 30 minutes, and patients in combined treatment see 2 therapists for a total of about 80 minutes. Oral IMI or placebo is taken daily.

Patients not responding to placebo or IMI after the initial 12 weeks are offered alternative treatment for up to 3 months or given a referral; responders continue to be treated monthly for the next 6 months. This is followed by a washout period of 6 months, after which patients receive final assessment. All therapy and assessment sessions are video- or audiotaped.

Patients are interviewed by an independent evaluator at the start of treatment and 3, 9, and 15 months later, and must keep a set of weekly self-monitoring forms. In addition, patients complete rating forms and questionnaires, and undergo carbon dioxide measurement at the start of treatment and 3, 9, and 15 months later.

At study conclusion, patients are told which medication they received and receive treatment recommendations.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Principal diagnosis of panic disorder with or without mild agoraphobia, confirmed using the Anxiety Disorders Interview Schedule-Revised
* At least one full or limited panic attack per week within 2 weeks prior to initial assessment and 2 weeks prior to treatment

--Prior/Concurrent Therapy--

* Drug washout required if on anxiolytic or antidepressant medication No more than 10 benzodiazepine doses (0.5 mg alprazolam equivalent) within 2 weeks prior to treatment No more than 20 doses of benzodiazepine during baseline and acute treatment combined No more than one dose of benzodiazepine per day permitted
* No concurrent competing treatment

--Patient Characteristics--

* Not pregnant Negative serum pregnancy test required Effective contraception required of fertile women No psychotic, bipolar, or significant medical illnesses Not suicidal No significant substance abuse No prior nonresponse to either study treatment or related treatments No concurrent disability claims
Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis

Embryo preservation through freezing plays a significant role in human assisted reproduction. It provides an opportunity for patients to have more than one attempt following an ovarian stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins and improving cumulative pregnancy rates. The purpose of this study is to compare effectiveness of two different freezing methods.


Eligibility Criteria:
Inclusion Criteria:

* ICSI with own gametes
* Couples who did not wish to cryopreserve their excess embryos for possible transfer in a future cyle
* Donating excess embryos for research purposes

Exclusion Criteria:

* Embryos derived from surgically retrieved spermatozoa
* Blastocysts
* Embryos of low quality (Grade 3 or 4 according to Hardarson)
Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.

Eligibility Criteria:
Inclusion Criteria:

Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered SUNITINIB MALATE(Sutent).
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation

Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients. Despite the efficacy of mitral valve repair, an ongoing international controversy exists regarding the need to perform early surgery in asymptomatic patients with severe MR and no sign of LV dysfunction in whom the probability of successful and durable repair is very high. In this group of patients, differing views of the risks of uncorrected severe MR exist: considered as benign by those supporting medical "watchful waiting" or associated with significant excess mortality/morbidity by those advocating early surgery. This controversy can only be resolved by a randomized controlled trial which is still lacking.

The main objective is to demonstrate the superiority of early mitral valve repair in patients with asymptomatic severe MR due to leaflet prolapse compared to an initial conservative management in terms of all-cause death and cardiovascular morbidity during five years follow-up.

Experimental group: In patients randomized to early mitral valve repair, surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up.

Control group: Patients randomized to initial conservative management will be followed up by clinical interview and echocardiography every 6 months. Patients will be instructed to report any change in functional status in a prompt manner. Surgery will be indicated at the onset of symptoms or if one or more of the following occur during follow-up: LV end-systolic diameter \>40mm, LV ejection fraction \<60%, recurrent atrial fibrillation, or resting systolic pulmonary artery pressure \>50mmHg.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic patients according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms
* Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography
* LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm
* Sinus rhythm on the inclusion ECG
* Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography.
* High probability of mitral valve repair
* EuroSCORE II ≤ 3%

Exclusion Criteria:

* Mitral stenosis or \> mild aortic valve disease (stenosis or regurgitation)
* Congenital heart disease (except patent foramen ovale or atrial septal defect)
* Patients with cardiac prostheses
* Previous myocardial infarction
* Previous cardiac surgery
* Extra cardiac comorbidity with life expectancy \< 5 years
* Recent history of psychiatric disease (including drug or alcohol abuse)
* Therapy with an investigational intervention at the time of screening or plan to enrol patient in additional intervention study during participation in this trial
Local Anesthetics New Formulations: From Development to Clinical Tests

This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
Laparoscopic Surgery in Elderly Patients

The primary purpose is to evaluate the quality of post-operative recovery and post-operative pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine prolapse.

Previous randomized clinical trial (NCT01887028) showed that the combined use of a low intraperitoneal pressure and a warmed, humidified CO2 gas resulted in better clinical outcomes (better quality of post-operative recovery and less post-operative pain) in patients aged 45-75 years, who underwent laparoscopic surgery for uterine prolapse.

Quality of post-operative recovery is very important in elderly patients. Investigators hypothesize that the combined use of a low intraperitoneal pressure and a warmed, humidified CO2 gas may also result in better clinical outcomes.

In this observational clinical trial, quality of post-operative recovery by QoR-40, post-operative pain by Visual Analog Scale, intra or postoperative complications and intraoperative core temperature are evaluated in elderly patients (more than 75 years old) who undergo laparoscopic surgery for uterine prolapse. Investigators use a low intraperitoneal pressure (6 mmHg) and a warmed, humidified CO2 gas during laparoscopy.

These outcomes will be compared with those of previous randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 75 years old
* Patients undergoing laparoscopic promontofixation with or without sub-total hysterectomy for uterine prolapse
* ASA class I or II

Exclusion Criteria:

* BMI more than 30
* Height less than 150cm