cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol

This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a screening visit, a qualification visit, a Treatment Phase and follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Male adults, between 21 and 45 years of age, inclusive.
2. Body mass index (BMI) within 19.0 to 34.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at screening).
3. Resting semisupine vital signs at screening and each clinic admission within the following ranges:

   1. Systolic blood pressure 90 to 140 mmHg
   2. Diastolic blood pressure of 50 to 90 mmHg
   3. Heart rate of 40 to 90 beats per minute (bpm)
4. Current alcohol users who are self-reported moderate drinkers, defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least 1 occasion in the 30 days prior to screening. One standard alcoholic drink (14 grams of EtOH) is equivalent to 43 mL (1.5 oz) hard liquor, 142 mL (5 oz) wine or 341 mL (12 oz) beer.

Exclusion Criteria:

1. Drug or alcohol dependence within the 12 months prior to screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
2. Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
3. Current or prior diagnosis of any condition where alcohol consumption is contraindicated, including, but not limited to, hypertriglyceridemia, pancreatitis, liver disease, porphyria, and/or congestive heart failure, that is clinically relevant, as judged by the investigator or designee.
4. Positive urine drug test for EtOH, cocaine, oxycodone and other opioids, amphetamines, benzodiazepines and/or cannabinoids at clinic admission. Positive results may be repeated and/or subjects rescheduled at the investigator's or designee's discretion.
Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.

The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less than 28 weeks of gestational age during the first 5 days of life.

A non-inferiority clinical trial, controlled, randomized and not blinded has been designed. The non-equivalent, experimental group consist on neonates less than 28 weeks of gestational age who are placed in lateral position while they are on kangaroo care during the first 5 days of life. On the other hand, the control group include neonates less than 28 weeks of gestational age who are in traditional prone position during kangaroo care on the first 5 days of life.

To define the sample size a power of 80% is assumed (β=0,20) and a 95% confidence interval (α=0,05) with a difference of 0,3ºC (SD 0,16) (9,10) in the axillary temperature. A non inferiority margin of 0.2ºC is established and a 10% sample size loss has been assumed. So a sample size of 35 premature in each group has been estimated.

A non probabilistic and consecutive sampling has been defined. The allocation into the experimental (lateral position) or control group (prone position) is going to be randomized.

The main outcome variable is the axillary temperature. However other clinical variables as pain, changes in the vital signs, HIV incidence rate are going to be measured as well.

Eligibility Criteria:
Inclusion Criteria:

* Premature under 28 weeks of gestational age with mother / father who wants kangaroo care.

Exclusion Criteria:

* Premature infants with mechanical ventilation in high frequency mode,
* Premature infants in the immediate postoperative period of major surgery,
* Premature infants with malformations of the abdominal Wall
* Premature infants who require immobilization
* Premature infants who do not tolerate kangaroo care: hemodynamic, thermal instability or increased stress
* Premature infants with duration of kangaroo care of less than 60 minutes.
* Also excluded are those patients where the kangaroo care provider has an anatomical limitation for carrying out kangaroo care.
NUCALA® Special Drug Use Investigation (EGPA, Long-term)

This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA). All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. Approximately 300 subjects will be included in the study. The observation period per subject is up to 96 weeks (2 years) from the start of NUCALA administration for EGPA at a maximum. If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. The total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of EGPA indication to the lifting of approval condition. NUCALA is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies.


Eligibility Criteria:
Inclusion Criteria:

* All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included.
* Subjects who had been registered to NCT03028480 for bronchial asthma, but had a change in treatment purpose from bronchial asthma to EGPA during the observation period

Exclusion Criteria:

* Not applicable.
Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation

The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.

Eligibility Criteria:
Inclusion Criteria:

* age 16-64
* Planned tonsil surgery with informed concent
* Obstructive sleep apnea (AHI \> 15)
* Tonsillar size of 3-4 on the Friedman scale

Exclusion Criteria:

* BMI \> 35 (Based on finnish Käypä Hoito -recommendations)
* Central sleep apnea
* Weight loss of more than 10% within the study period
* Untreated obstruction of nasal breathing
* Treated peritonsillar abscess \<1 month before enrollment
* Active tonsillar infection
* Previous tonsillar surgery (excluding incision of abscess)
* Malignancy
* High use of analgesics \>1 DDD daily during last 4 weeks
* Untreated reflux
* Anticoagulative medication
* Any condition of hemophilia
* Pregnancy, lactation
* Other, evaluated by treating physician
Retrospective Study on Clinical Results of Preimplantation Genetic Screening at Different Embryo Stage

Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov. Patients underwent PGS and data including the couples age, infertility factors, stimulation protocols, medicine records, embryo quality records and blood tests were collected in this study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo quality is performed and further to find a diagnosis reference for clinical care.

Research background Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. For the preemergence of embryos before the genetic diagnosis must be carried out artificial reproductive treatment, the process includes induction of ovulation, ovulation, in vitro fertilization and embryo culture, to embryos grow to six to eight cells or cultured into the stage of blastocyst stage, Under the embryonic section, take one or several cells, the slices of cells for genetic diagnosis, select the embryo without genetic disease implanted in the uterine cavity, in order to avoid the birth of genetic disease offspring.

PGS can reduce the pregnancy when the chromosomal abnormalities of the fetus after implantation, but also to reduce the risk of abortion from chromosomal abnormalities, and can avoid the couples implanted with genetic abnormalities of the embryos, thereby significantly reducing it is important to promote the process of eugenics and reduce the social cost.

Research purposes The detection of chromosomal abnormalities of embryos are important factors for clinical diagnosis or screening before implantation. However, there is no complete analysis of domestic studies. This program will compare the genes or chromosomal abnormalities and clinical outcomes of embryo testing at different stages of embryonic development.

Research design This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov. Patients underwent PGS and data including the couples age, infertility factors, stimulation protocols, medicine records, embryo quality records and blood tests were collected in this study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo quality is performed and further to find a diagnosis reference for clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Women underwent in vitro fertilization (IVF) treatment and preimplantational genetic screen (PGS).

Exclusion Criteria:

* N/A
Optimizing Electronic Alerts for Acute Kidney Injury

This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.

Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.

The investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.

This study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. The primary outcome will be a composite of progression of acute kidney injury, dialysis and death.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years admitted to a participating study hospital
* Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).

Exclusion Criteria:

* ESKD diagnosis code
* Dialysis order prior to AKI onset
* Initial creatinine \>=4.0mg/dl
* Prior admission in which patient was randomized.
* Admission to hospice service or comfort measures only order
* Kidney transplant within 6 months
Genetic Architecture of Avoidant/Restrictive Food Intake Disorder

The goal of this observational study is to rapidly accelerate knowledge about the biology of avoidant and restrictive food intake disorder or ARFID in children ages 7-17 and in adults. The investigators will be evaluating the genetic and environmental origins of ARFID. Participants will be asked to answer questionnaires online and to submit a saliva sample for DNA using a kit that will be mailed to their home.


Eligibility Criteria:
Inclusion Criteria:

* Meet study criteria for ARFID
* Be willing to submit a saliva sample
* Have a US mailing address
* English-speaking

Exclusion Criteria:

* Potential other eating disorders
Internet-based Support for Adjustment to Prostate Cancer

The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.

Men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. Examples include depressed mood and worry regarding the prognosis and/or cancer recurrence. Psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms.

This study investigates a tailored approach to providing help for men diagnosed with prostate cancer. Participants randomized to the treatment condition will receive an eight week ICBT intervention which is tailored to the problem profile of the participant in question. The treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. Participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. The primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. Participants will be recruited in Sweden with a nationwide recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis.
* A sum score above 19 on the primary outcome measure (Kessler-10).
* An age of 18 or older.
* Ability to speak, read, and write Swedish.
* Access to a computer/laptop/tablet/smartphone and internet access.
* Sufficient computer profiency to be able to use the treatment platform.

Exclusion Criteria:

* Planned medical treatment or planned change in medication related to the prostate cancer during the treatment period.
* Recently finished (within the past six months) medical treatment for prostate cancer.
* Severe psychiatric or somatic conditions that impedes participation in the study.
* Ongoing substance use problems.
* Acute suicidality.
* Other ongoing psychological treatment.
* Psychopharmaceutic treatment that has been changed within the past month or with planned changes during the treatment phase.
Community Point Distribution of Insecticide Treated Bed Nets

All households in three zones in Zambia's Eastern Province were invited to attend a community point distribution of insecticide treated bed nets (ITNs). Households were then randomized to different intervals for a community health worker (CHW) hang-up visit.

Households were asked to attend a community point distribution of ITNs in one of three zones in Zambia's Eastern Province. Households that had been registered to receive ITNs were then randomized to one of five groups that received a CHW visit at different intervals. Group 1 was visited 1-3 days after distribution, group 2 was visited 5-7 days after, group 3 was visited 10-12 days after, group 4 was visited 15-17 days after, and group 5 did not receive a hang-up visit. Groups 1-4 were categorized as having received a hang-up visit and group 5 was categorized as not having received a hang-up visit. All households in all five groups were visited at 7-11 weeks after the distribution and again at 5-6 months after the distribution to assess short- and medium-term ITN retention and usage.

Eligibility Criteria:
Inclusion Criteria:

* Household was pre-registered by the National Malaria Control Centre to receive ITNs ahead of the start of study activities.
* Household was located in one of the three study areas of Mukonka, Lukwipa, and Chipeketi in Rufunsa District, Zambia

Exclusion Criteria:

* Household was not pre-registered to receive ITNs
* Household was not located in one of the three study areas
Revisional Bariatric Surgery Experience

The aim of this study is to assess the indications for revisional bariatric surgery and short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive weight loss and % excessive BMI loss .Prospectively-collected patient data will retrospectively reviewed. Patient demographics, body mass index (BMI), primary and revision surgery types, indications of revision, outcomes of revisional surgery and follow-up data for comorbidities will investigated.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 to 65 years old,
* Patients who undergo revisional bariatric surgery due to renewed weight gain, stenosis or alkaline reflux after primary bariatric surgery

Exclusion Criteria:

* Eating disorders,
* Alcoholic
* Cancer
To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation

This study is a randomized, controlled, observational study. 150 nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation will be enrolled as subjects in the two groups is 1:1. In the experimental group, vaginal examination will be performed at 39 to 40 weeks to assess cervical conditions. If the bishop score \<6, the balloon catheter combined with oxytocin induction will be planned at 40 weeks ±3 days. In the control group, one week to 41 weeks ±3 days will be expected. Vaginal examination will be performed again to evaluate cervical conditions. If the bishop score \<6 points, and balloon catheter combined with oxytocin induction will be performed. After 96h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.


Eligibility Criteria:
Inclusion Criteria: singleton head position pregnancy, negative Down's screening and /or NIPT screening, no malformation was found, with slight/without pregnancy complications -

Exclusion Criteria:twin or multiple pregnancy, scar uterus, with contraindications to vaginal delivery, estimated fetal weight \>4500g

-
A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)
* Patients were able to get their first dose of study medication within 8 hours after the end of surgery

Exclusion Criteria:

* Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation
* Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures
* Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening
* Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation
Betafoam Diabetes Mellitus Foot Study

This study is to compare the efficacy and safety of Medifoam® and Betafoam®, which is a new dressing that contains povidone-iodine, in patients with diabetes foot ulcer. 70 patients (35 each arm) are targeted to be enrolled in this study. Treatment follow periods are 8weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult of age ≥19 years at the time of informed consent
* Foot ulcers related to diabetes mellitus:

  * Present
  * Type I or II diabetes mellitus with HbA1c \<10%, or serum creatinine ≤ 200 μmol/l
  * Wagner grade I-II (Partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule)
  * Post -debridement ulcer bed size ≥ 1\*1cm2
* No clinical signs of infection \& necrosis
* Site at anywhere below ankle
* No vascular abnormalities of the foot by palpation (i.e. the dorsalis pedis should be examined by the physician and characterized as present or absent)

Exclusion Criteria:

* Pregnant \& lactating females
* Known allergy to the dressing product including povidone iodine
* Known hyperthyroidism or other acute thyroid diseases
* Subject with clinical infection who should be administered antibiotics continuously after enrolment
* Subject has any condition(s) that seriously compromises the patient's ability to complete this study.
* Subject has participated in interventional study utilizing an investigational drug within the previous 30 days
* Subjects with known immune-suppressed state; who undergo chemotherapy or with end-stage renal disease requiring haemodialysis or had kidney transplant surgery previously and with immunosuppressant specifically
* Subjects requiring skin grafting per physician's discretion
* Vulnerable subjects as defined by Good Clinical Practice guidelines.