cyrilzakka/clinical-trials huggingface dataset:
Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy

This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will be analysed.

Screening for sleep disordered breathing (Respiratory disturbance index, RDI ≥ 5 events/hour) with type 2 sleep test will be performed in eligible subjects during early1st trimester (\<16 weeks). Repeat sleep study will be done if the RDI in 1st trimester is less than 5. If the subjects meet the inclusion criteria without any of the exclusion criteria, randomization into either receiving CPAP treatment or usual ANC will be done. The pressure of CPAP machine is determined using autoCPAP machine algorithm at 90 percentile. Adjustment of CPAP machine is repeated at 24-28 week gestations. Subjects in both groups received standard usual care during ANC and outcomes were measured with similar case record forms.

Eligibility Criteria:
High risk pregnant women attending the antenatal care at the collaborated hospitals will be eligible for the study if they meet all following inclusion criteria.

Inclusion criteria (ALL criteria)

1. Singleton pregnant women age ≥ 18 years
2. Pregnant women attending the antenatal care and intending to deliver at one of the study hospitals with gestational age \< 16 weeks
3. Thai nationality with ability to use Thai language proficiently both in spoken and written language.
4. Have been diagnosed as high-risk pregnancy by Obstetricians by having any of the following conditions

   1. Chronic hypertension prior to pregnancy
   2. Hypertension during pregnancy before 20 weeks gestation.
   3. Pre-eclampsia/gestational hypertension during recent pregnancy
   4. Obesity defined by pre-pregnancy body mass index (BMI) ≥ 27.5 kg/m2
   5. History of diabetes mellitus or gestational diabetes
   6. Having gestational diabetes or overt diabetes
5. Presence of snoring (either as frequent snoring ≥3 times/week or loud snoring) prior to or occurring during pregnancy OR respiratory disturbance index, RDI ≥ 5 events/hour by type 2 sleep testing at either point of testing during early pregnancy (0-16 GA week) or late pregnancy (GA 24-28week ).
6. Sign written informed consent

Exclusion Criteria:

1. Subjects' unwillingness to participate in the study at any time of the study.
2. Subject with significant medical conditions such as immunocompromised status, chronic infection (HIV infection, tuberculosis), chronic lung and cardiac conditions, chronic renal failure, thyroid disease, or neuromuscular disease.
3. Subjects with extremely severe obstructive sleep apnea (RDI ≥30) or with significant O2 desaturation \<80% during sleep that might have potential benefit from the CPAP treatment.
4. Subject with known obstructive sleep apnea and currently on CPAP treatment
Monitoring to the Evolution of Motor Function in SMA Type II Adults Patients Treated With SPINRAZA®

SPINRAZA® (Nusinersen) is the first intrathecal administered drug which was approved by the FDA to treat SMA children and adults (2016). The aim is to monitor the evolution of the Motor Function Measure-32 for SMA type II adult patients treated with SPINRAZA® (Nusinersen).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with SMA type II disease who are wheelchair bound,
* Must be 18 years or older,
* Men or Women with SMA type II disease (age at symptoms onset: \>6 months old and who never acquired the capacity to walk but acquired the ability to sit without support) with genetic confirmed diagnosis of 5q SMA homozygous gene deletion (SMN1 exon 7/8) or mutation or compound heterozygous mutation - performed by PCR amplification and restriction digest of DNA using primers flanking SMN1 and SMN2 exon 7.
* MFM 32 score ≥ 19/96
* Lumbar CT scan showing the feasibility of intrathecal injection.
* Written informed consent from the subject prior to initiation of any study-mandated procedures
* Females of childbearing potential must have a negative pregnancy test at Screening and at Enrollment, must agree to use reliable method of contraception (if sexually active) from screening up to study drug discontinuation plus 180 days.

Exclusion Criteria:

* Patients with a high risk for thrombocytopenia or hemorrhage or renal diseases: Urine protein, platelet count and coagulation tests will be done prior to intrathecal injection with SPINRAZA®
* Patients with high risk of hydrocephalus
* Adult patients under guardianship
* Pregnant and/or breastfeeding females
* Subject has received any investigational therapy or pharmacological treatment for SMA one month prior the beginning of the study
* Subject has received gene therapy for SMA
Assessment of the Prevalence of TTR Amyloid Neuropathy in a Population of Patients With Neuropathy of Unknown Aetiology

Familial amyloid neuropathy due to transthyretin gene mutations (TTR-FAP) is a rare autosomal dominant inherited disease resulting in the abnormal multi-system deposition of amyloid proteins. These deposits produce a multi-organ disease. AP is usually fatal 10 to 15 years after onset of symptoms if untreated. The prevalence of the disease remains still poorly understood and usually the search for this pathology is done in a third line of investigation. So the average time to diagnosis is extremely long, from 12 to 24 month. Now that the investigators have etiological treatment ( famidis (Vyndaqel®) and Diflunisal (Dolobid)) of this disease, it is essential to be able to detect FAP patients as early as possible. With this study, investigator decided to test for TTR mutation all patients presented with neuropathy of unknown etiology at the first line of investigation. The goal of this study is to evaluate the prevalence of FAP-TTR among neuropathy and defined the best strategy to test this population for TTR mutations.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (male and female) aged not more than 90 years old
* Patients with neuropathy identified by EDX exam or small fibre neuropathy identified from a skin biopsy.
* Patients who have undergone the minimal assessment for neuropathy as defined by the HAS (French National Health Authority): biological analysis (fasting glucose, CBC, liver and renal functions, CRP, pituitary TSH)
* Patients belonging to the social security system
* Patient who gave written informed consent

NON-INCLUSION CRITERIA Patients under legal supervision or guardianship Patients with a confirmed documented diagnosis of the cause of neuropathy Patients with evidence of Charcot Marie Tooth neuropathy: very slowly progressive course, pes cavus.

Patients who have already been investigated for a TTR mutation Pregnant women Minors
A Comparison of Hearing Aid Fitting Methods

This investigation will compare hearing aid fitting methods between self-fitting and clinician fitting approaches by using a standardized questionnaire to evaluate subjective hearing aid benefit.

Participants will be fit with hearing aids using two different fitting methods (fitting A and fitting B). The order of the fitting will be randomized such that half of the participants will start out with fitting A and half of the participants will start out with fitting B. All participants will undergo baseline speech testing and answer a questionnaire about their experiences in daily life without hearing aids. All participants will use devices for a period of 1-2 weeks in their daily lives. After this first home trial, participants will return to the clinic where they will answer questionnaires regarding their experience with the devices. They will also perform aided speech testing. They will then be given devices with the second fitting method and will wear devices for a period of 1-2 weeks in their daily lives. Following the second home trial, all participants will return to the clinic to answer the same questionnaire that was given after home trial #1, and complete aided speech testing. The results for each of the two fitting methods will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate bilateral hearing loss
* First time (new) hearing aid users or experienced hearing aid users
* Ability to use a smartphone
* Fluent in English; ability to read and write in English
* Willing and able to provide informed consent

Exclusion Criteria:

* Self reported ear-related pathology including otorrhea within 90 days, dizziness, sudden onset or worsening of hearing loss within 90 days, visible deformity of the ear, otalgia
* Unilateral hearing loss
* Chronic, severe tinnitus
Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC)

Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma

To assess therapeutic efficacy and safety of Oncoxin in hepatocellular carcinoma

To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin

To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin

To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin

To see if there is improved survival in hepatocellular carcinoma patients after administration of oncoxin

Eligibility Criteria:
Inclusion Criteria:

* Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease.
* Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who have evidence of tumor metastasis
* Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC in whom all possible treatment options have been exhausted.

Exclusion Criteria:

* Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who have no evidence of tumor metastasis
* Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who are voluntarily unwilling to be included in the trial
Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a disease where the blood pressure in the pulmonary arteries (PAP) is high. PAH increases the risk of adverse events, including death, during and or after procedures. The severity of baseline PAH correlates with the incidence of major complications, such that those with PAP higher than their systemic blood pressure (SBP) had a 8 fold increased risk of complications. These children present for procedures where an acute exacerbation of their chronic illness-termed Pulmonary Hypertensive (PH)crisis, can occur, often resulting in death if not detected and managed expeditiously. Unfortunately there is little data and no consensus in the pediatric literature on how PH crisis should be managed.

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Pulmonary arterial hypertension (PAH) is a disease where the blood pressure in the pulmonary arteries (PAP) is high. PAH increases the risk of adverse events, including death, during and or after procedures. The severity of baseline PAH correlates with the incidence of major complications, such that those with PAP higher than their systemic blood pressure (SBP) had a 8 fold increased risk of complications. These children present for procedures where an acute exacerbation of their chronic illness-termed PH crisis, can occur, often resulting in death if not detected and managed expeditiously. Unfortunately there is little data and no consensus in the pediatric literature on how PH crisis should be managed. Over the last 10 years we have developed considerable expertise in managing children with PAH and preventing and treating their acute crisis, using a medication called phenylephrine. This medication is routinely used to increase the blood pressure in patients (adults and children) to treat hypotension. Our theory has been that by increasing SBP, we can increase the blood flow to the coronary arteries and prevent the right ventricle from failing acutely. The latter results in catastrophic hypotension, heart arrythmias and death. There is no consensus or protocol guiding the management of the acute crisis. This purpose of this study is to close that gap.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for cardiac catheterization procedure with a diagnosis of PAH either by previous cardiac catheterization or echocardiography

Exclusion Criteria:

* Children presenting for cardiac catheterization who do not have PAH;
* Children with PAH but with intracardiac shunts
Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair

Anterior colporrhaphy is the commonly performed surgery for pelvic organ prolapse. However the success rates of native tissue repair techniques for anterior vaginal prolapse range from %30-%70. According to a systematic review of the anterior colporrhaphy technique, there was no ideal procedure or guideline for gynecologists to perform. The investigators tried to compare pubocervical fascia suturing techniques with the ideal procedure type by determining step by step all parts of the surgery including the anesthesia type. The aim of the study will be to compare the pubocervical fascia reconstruction techniques in the management of anterior compartment defects (POP-Q \>2) at 1 year and yearly up to 2 years.

Primary and secondary endpoints:

Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.

Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.

The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.

Project design: The investigators will perform an international singlecentre single-blind randomized controlled trial by participating in our tertiary referral hospital.

Eligibility Criteria:
Inclusion Criteria:

* Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) cystocele
* Women aged between 18-75 years of age

Exclusion Criteria:

* Women not eligible for surgery for medical or anesthesiological reasons
* Inability to comprehend questionnaires
* Inability to give informed consent
* Inability to return for a review
* Prior anterior compartment repair with or without mesh
* Severe cardiovascular or respiratory disease
* Women who don't want anterior compartment repair
* Pregnancy
* Age \<18 years
Impact of Different Perioperative Tourniquets on Blood Loss and Surgeon Satisfaction in Total Knee Arthroplasty

The present study investigates the impact of two different perioperative tourniquets with different closing features on operative blood los, surgical field quality and surgeon satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Inidication for a Total Knee Arthroplasty
* Approval for Surgery by the Department of Anesthesia

Exclusion Criteria:

* Open Wounds of the lower extremities
* Acute or chronic infections of the lower extremities
Adenovirus Vaccine Pregnancy Registry

The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect data concerning:

1. Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral,
2. Potential confounding factors, and
3. The outcome of these pregnancies.

The secondary purpose of the Adenovirus Vaccine Pregnancy Registry is to evaluate the frequency of birth defects in prospectively enrolled pregnant women. This Registry is also designed to detect any unusual patterns of birth defects.


Eligibility Criteria:
Inclusion Criteria:

For women:

* U.S. Military service member, present or former
* Confirmed exposure to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
* Received Adenovirus Type 4 and Type 7 Vaccine, Live, Oral while pregnant or has an estimated date of conception (DOC) within 6 weeks after receiving Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
* Positive β-hCG test or fetal ultrasound,and
* Verbal and/or written informed consent obtained from the patient.

For live born offspring:

* Infant born to a woman meeting the above inclusion criteria and enrolled in the Registry, followed through one year post delivery, and
* Verbal and/or written informed consent obtained from the mother of the infant.

Exclusion Criteria:

* Patients who refuse to provide informed consent (verbal or written) to the Institutional Review Board (IRB)-approved informed consent.
* Females not exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral within the inclusion criteria period.
* Patients not willing to meet Registry study conditions and requirements.
Effect of Cilostazol on the Pharmacokinetics of Simvastatin

To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects.

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Samsung Medical Center on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed simvastatin 40 mg orally around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests and pharmacokinetic samplings for simvastatin. Subjects were dosed cilostazol 100 mg in the morning on Day 2 and discharged, and visited Clinical Trials Center on Day 3, Day 4 and Day 5 for the oral administration of cilostazol 100 mg. Subjects was admitted in the evening on day 5 and dosed simvastatin 40 mg plus cilostazol 100 mg concomitantly and scheduled pharmacokinetic sampling for simvastatin was performed. Next morning (Day 7), subjects were discharged

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 48 years
* A body mass index (BMI) in the range 19-27 kg/m2
* Provide written informed consent after being fully informed about the study procedures
* Subject without any congenital or chronic disease and with no pathologic symptom in the physical examination
* Determined eligible in the ECG, clinical laboratory tests and urinalysis

Exclusion Criteria:

* Use of medication which induces or inhibits drug metabolizing enzyme (CYP3A4 etc.) within 30 days prior to drug dosing
* Use of medication within 10 days before first dose
* Abnormal diet that can influence on tlhe ADME of drugs (grapefruit juice etc.)
* Presence or history of clinically significant allergic disease, alcohol abuse, drug hypersensitivity
* Whole blood donation during 60 days before the study
* Participation in other clinical trial within 90 days prior to scheduled study drug administration
* Subject judged not eligible for study participation by investigator
Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation

To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. The following criteria will be used.

   1. Two of the following

      * Serum total bilirubin \> 2.0 mg/dL
      * Hepatomegaly or right upper quadrant pain of liver origin
      * Unexplained weight gain of\>2% over baseline because of fluid accumulation
   2. Patients with pathologic diagnosis.
2. Patients with informed consent

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
5. History of anaphylactic reaction to the study drug
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate

RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy.

PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate.

OBJECTIVES:

* Determine the effectiveness of carboxypeptidase-G2 rescue in patients who develop life threatening methotrexate (MTX) neurotoxicity following accidental intrathecal MTX overdose.
* Study the CSF pharmacokinetics of MTX following rescue.

OUTLINE: Patients undergo a lumbar puncture as soon as possible after methotrexate overdose to remove methotrexate and receive a single dose of carboxypeptidase-G2 intrathecally over 5 minutes.

Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A maximum of 10 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients who received an intrathecal overdose of methotrexate of 100 mg or more

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No prior anaphylactic reaction to carboxypeptidase-G2 administration

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Concurrent therapy allowed