cyrilzakka/clinical-trials huggingface dataset:
Pregnancy and Birth Outcome in Women With Pompe Disease

This study explores the outcome and effect of pregnancy on Pompe Disease. The results are expected to guide clinicians in counseling and care of women with Pompe disease, who are planning to become pregnant, and during the pregnancy.

Pompe disease (glycogen storage disease type II) is a lysosomal storage disorder resulting from the deficiency of the enzyme acid alpha-glucosidase. Similar to many lysosomal storage diseases, the phenotypic spectrum in Pompe disease is varied, existing in infantile, and late-onset forms. In the classic infantile form, patients develop cardiomyopathy, resulting in premature death. In the later-onset forms, there is proximal muscle weakness similar to that of limb-girdle muscular dystrophy, which is associated with progressive weakness of different muscle groups. The primary morbidity in Pompe disease is associated with progressive respiratory insufficiency.

Events that act as metabolic stressors, in general, such as pregnancy may act as modifiers in lysosomal storage disorders. In much studied Gaucher disease, pregnancy increased the risk of acute bone crises, even in otherwise asymptomatic patients. However, similar studies lack for Pompe disease. Most data that is used to counsel patients with Pompe disease are derived from other muscular dystrophies, because obstetric risk and complications.

This is a retrospective case review study in female subjects age 18years and above. This study investigates the effects of acid alpha-glucosidase deficiency on pregnancy, pregnancy and disease outcomes in patients with adult-onset Pompe disease. The study will define the immediate effect of enzyme replacement therapy with Lumizyme/Myozyme on the outcomes of pregnancy and the fetus.

Subjects will be invited to participate through an initial mail or phone contact. If patient is interested, and agrees to participate in the study the study questionnaire will be provided to them. The patients then, need to complete the questionnaire, sign and date it and mail it back along with a release of any medical information forms. The returned signed and dated questionnaire from the patient serves as an indication of their consent to participate in the study. Alternatively, study PI or coordinator may review the questionnaire with the subject during a phone interview. However, the subject's signature is still required to attest to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Pompe disease
* Females age 18 and over
* Have been pregnant or anticipating pregnancy in near future.

Exclusion Criteria:

* If the diagnosis of Pompe disease is not confirmed
* If the subject is not able to consent
Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy

Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of $11.5 billion or $921,000 average cost per person. Associated disabilities as mental retardation, delayed speech development add psychological burden of the disease on the family as well as economic burden.

Mental retardation is the major problem in children with cerebral palsy. Improving mental development will have a positive effect on quality of life for the child and his family. Treating associated impairments (mental retardation) with Cerebrolysin will improve mental development and quality of life, and will decrease the economic burden in children with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy with mental retardation
* Severe perinatal brain insult

Exclusion Criteria:

1. Severe growth retardation
2. Gastrostomy tube feeding
3. Intractable seizures.
4. Severe motor handicap and deformities from long standing spasticity.
5. Congenital malformations.
6. Suspected inborn error of metabolism.
7. Suspected inherited neurologic disease.
8. Children with auditory and visual impairments.
9. Care giver's refusal to participate in the study.
Modification of Risk Factors Associated With Knee Injury in Netball

Noncontact knee injuries are a concern in netball. As such, it is important to devise appropriate injury prevention programs that players will complete to reduce the risk of injury. Previous research suggests that the most common situation of noncontact knee injury in netball involves a stiff landing or apparent knee valgus collapse, trunk rotation, and lateral flexion. Therefore, the aim of this study is to investigate the effect of a neuromuscular training program on biomechanical risk factors during a netball-specific landing.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-45 years
* No history of lower limb injury in the last 6 months
* No history of concussion in the last 6 months
* No history of any knee surgery
* Currently playing recreational netball at least once per week

Exclusion Criteria:

* Male
* Under 18 years or over 45 years of age
* Suffered from a lower limb injury in the last 6 months
* Suffered from concussion in the last 6 months
* Any history of knee surgery
* Not currently playing recreational netball at least once per week
Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

The main cause of recurrence after surgical treatment of colon cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. This randomized multicenter phase III trial is assessing whether preoperative chemotherapy improves oncologic outcomes of patients with locally advanced colon cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed colon adenocarcinoma (\> 15 cm from the anal verge)
* Radiologic T3/T4 and high risk features by CT scan
* No metastasis on CT or PET(positron emission computed tomography)
* Age ≥ 18 and ≤ 70 years
* ECOG (Eastern Cooperative Oncology Group) performance status 0-1
* No history of colorectal cancer within 5 years
* No history of chemotherapy
* Patients with childbearing potential should use effective contraception during the study and the following 6 months
* Adequate bone marrow function : white blood cell count of 2 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more
* Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less
* Adequate renal function : GFR (Glomerular Filtration Rate) \> 50ml/min by Wright or Cockcroft formula
* Signed written informed consent obtained prior to any study specific screening procedures

Exclusion Criteria:

* Age \> 70 years and \< 18 years
* Rectal cancer : 15 cm or less from the anal verge
* Complicated colon cancer (complete obstruction, perforation, bleeding)
* Metastatic colon cancer
* Known hypersensitivity reaction to any of the components of study treatments
* Inflammatory bowel disease
* Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis
* Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia
* Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Pregnancy or breast-feeding period
* Serious non-healing wound or bone fracture
* Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
* Any significant disease which, in the investigator's opinion, would exclude the patient from the study
Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.

Hypothesis:

Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.


Eligibility Criteria:
Inclusion Criteria:

1. Male, age 40-80 years.
2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
3. Diagnosis of Dysthymic disorder with onset after age 40.
4. PSA \< 4.0.
5. Normal digital exam of the prostate in the preceding 1 year.
6. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D \> 12).
7. Able to give informed consent.

Exclusion Criteria:

1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
2. Currently being treated with testosterone.
3. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
4. Current suicidal risk.
5. Current (past year) substance abuse or dependence.
Validation of the French Version of the Edinburgh Postnatal Depression Scale (EPDS) Postnatally in the Father

In recent years, fatherhood has changed considerably. Fathers are now more involved during the perinatal period, with their partner but also in caring for the child. We now know that this period is also a source of major psychological upheaval, identity crisis, apprehension and anxiety for men. These upheavals can lead to depression that must be detected and treated as early as possible. This is an easy screening to perform using the EPDS (Edinburgh Postnatal Depression Scale). Currently, the EPDS is the most widely used self-questionnaire to assess the risk of depression in women during the perinatal period. Indeed, it is systematically recommended in many countries. It is starting to be used for the same purpose in the perinatal period in men, although the scale has not been validated in a representative sample of men in the pre- or post-natal period.

The main objective is to validate the use of the EPDS scale as a screening tool for postnatal depression in a population of French fathers.

They complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.


Eligibility Criteria:
Inclusion Criteria:

* All fathers whose baby is 10 days old or less

Exclusion Criteria:

* People with a poor understanding of spoken or written French
* Minors
* Persons under court protection, guardianship or curatorship
The Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy

Skull pins are used to immobilize the head during craniotomy. Fixation of skull pins causes acute hemodynamic changes which may affect cerebral autoregulation and hence cerebral blood flow. Therefore, maintenance of stable hemodynamic parameters during skull pin placement under general anesthesia is crucial to ensure adequate cerebral perfusion and prevention of acute rise of intracranial pressure

Many different strategies have been used to minimize the hemodynamic responses to skull pin placement with varying results. Local anesthetic infiltration at pin application sites has been used but was always unsuccessful in obtunding the hemodynamic responses to skull pin placement. Dexmedetomidine, an alpha-2 adrenoceptor agonist, has been recently introduced as a sedative for patients on mechanical ventilation. In addition to its sedative effect; Dexmedetomidine has significant analgesic qualities and has been labeled as "analgesia-sparing". To the best of the investigator's knowledge, few studies investigated Dex use to suppress hemodynamic responses to skull pinning. The aim of the current study was to evaluate the lowest effective dose of Dexmedetomidine in attenuating the hemodynamic responses to skull pin placement for craniotomies. Lidocaine, administered subcutaneously at the head-holder pin sites, was more effective in preventing the blood pressure response to skull-pin than was deepening the level of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 120 Adult patients,
* undergoing elective craniotomy
* ASA I and II patients

Exclusion Criteria:

* patients undergoing craniotomy for emergency surgery,
* raised ICP,
* obese patients (body mass index \>30 kg/m2 for males and 28 kg/m2 for females),
* patients having systemic comorbidities (cardiac, renal, hepatic, and endocrinal),
* hypertensive patients (including those detected after admission),
* patients undergoing intracranial aneurysm clipping
Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases.

The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 12w, 24w, 36w, 48w.all participants will be required to check the various efficacy and safety indicators.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent signed;
2. Age ≤75 years;
3. Clinically or multidisciplinary diagnosed idiopathic pulmonary fibrosis(see 2011 guidance );
4. Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value.

Exclusion Criteria:

1. Allergic to pirfenidone;
2. Patients with serious Significant pulmonary infection need anti-infection treatment;
3. Patients who has taken interferon, penicillamine or other agents for the treatment of IPF;
4. Patients who has taken prednisone(≥50mg) or other glucocorticoid in the past 1 month;
5. Patients who has taken immunosuppressants in the past 1 month;
6. Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
7. Patients with malignant tumor in the past 5 years;
8. Participated in other clinical trials in the past 3 months;
9. Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), liver disease(ALT or AST 2 times above the upper level of normal value range), kidney disease(Cr above the upper level of normal value range);
10. Pregnant or lactating women;
11. The investigator assessed as inappropriate to participate in this clinical trial.
Traveler's Constipation

The occurence of traveler's constipation is sparsely covered in the medical litterature. This study aims to determine the gastrointestinal-related discomforts related to traveling on a trip to Turkey.

Traveler's constipation, which is characterized by the more hard and less frequent stools, is sparsely covered in the medical litterature. Only a few studies have examined this problem and the actual occurrence and extent of this problem is not known. Hypotheses about why travel constipation occurs are, among other things, about changed circadian rhythm due to jet lag, changed schedules and tight sanitary conditions. Other factors such as dehydration, change in cabin pressure and the content of the in-flight food in connection with flights have not been investigated.

The research project aims to clarify changes in the test subjects' bowel habits as well as other gastrointestinal-related discomforts in connection with a flight abroad with only an hour's time difference and without the consumption of flight food.

Eligibility Criteria:
Inclusion Criteria:

* Can understand danish and is able to answer the questionnaires
* Given written consent

Exclusion Criteria:

* History of intestinal resection
* Medically treated intestinal disease
* IBS at baseline
Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients

Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence. Complementary and alternative medical approaches have been employed to relieve symptoms of Atopic Dermatitis. We aim to establish basic clinical efficacy and safety data for Jaungo in patients with Atopic Dermatitis.

This study is a randomised, double blind, placebo-controlled, single-centre trial with three parallel arms (trial group 1, trial group 2, and control group). The diagnosis of Atopic Dermatitis will be made according to the criteria of Hanifin and Rajka. Participants will receive Jaungo or a placebo-drug for three weeks. Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in trial group 2 will apply Jaungo to the lesion twice a day for three weeks. Participants in control group will apply placebo to the lesion twice a day for three weeks. Each participant will be examined for EASI (Eczema area and severity index), SCORAD (SCORing of Atopic Dermatitis), TEWL (Transepidermal water loss) and DLQI (Dermatology Life Quality Index) before and after applying medication. The outcomes to evaluate the maintenance of safety are Draize score, blood test and expert's opinion.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of AD will be made according to the criteria of Hanifin and Rajka
2. Age: 5 years to 65 years
3. objective SCORAD ≦40, Diagnosis of Mild to Moderate Atopic Dermatitis (AD)
4. Exoriation≥1, Lichenification≥1, Dryness≥1 or Exoriation+Lichenification+Dryness≥3
5. Participants who able to express intention
6. Participants willing to provide written informed consent

Exclusion Criteria:

1. Participants have oozing in the lesion
2. Users of following medications prior to trial periods

   ① Oral steroids, immunosuppressants and antibiotics within 4 weeks prior to this trial

   ② Topical steroids, immunosuppressants and antibiotics within 2 weeks prior to this trial

   ③ Light therapy within 2 weeks prior to this trial

   ④ Other medications thought to be inappropriate by researchers
3. Participants have severe burn or wide wound
4. Participants have oozing or ulcer in the lesion
5. Allergic reactions to Angelica gigas, Siebold et Zuccarini, sesame oil and lard
6. Participants have skin disease except atopic dermatitis
7. Participants have severe renal function disease (sCr \> 2.0 mg/dL)
8. Participants have severe liver function disease (ALT, AST, ALP ≥ 2.5 × normal limits)
9. Participants have uncontrolled chronic diseases
10. Pregnancy, lactation
11. Participation in another clinical trial within one month of enrolment
12. Underlying disease or history of severe disease, abnormal state (paralysis; mental retardation other emotional or mental problems; diseases that can affect the absorption of drugs; no enough time to participate in this trial; visual disturbance and hearing impairment; inability to understand written consent or engage in this study)
13. Judgment by experts that the potential subject's participation is inappropriate.
A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants

The purpose of this study is to determine the effect of baricitinib on the levels of digoxin in the blood stream and how long it takes the body to remove digoxin. This study will also look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in healthy participants. This study will last approximately 3-4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Women not of child-bearing potential
* Menopausal women
* Have a body mass index of 18.0 to 29.0 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* Women who are lactating
* Have previously completed or withdrawn from this study or any other study investigating baricitinib
* Currently enrolled in, have completed or discontinued within the last 90 days from a clinical trial involving an investigational product
* Have a pulse rate less than 50 beats per minute (bpm) at screening
* Have a current or recent history (less than 30 days prior to screening and/or less than 45 days prior to Day -1) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
* Have an absolute neutrophil count less than 2000 cells/microliter (2×10\^9/liter) at screening or Day -1
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine
* Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study
* Have used or intend to use any drugs or substances that are known to be substrates, inducers, or inhibitors of P-glycoprotein (P-gp) within 30 days prior to dosing and throughout the study
* Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
Is NIRS Able to Detect Ischemia Following Brain Insult

We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated.


Eligibility Criteria:
Inclusion Criteria:

* Necessity of monitoring by PtiO2 and ICP

Exclusion Criteria:

* Inability to apply NIRS sensor
Dental Loupes in Pediatric Dentistry Practice Affect Ergonomic Posture

This study aims to investigate the effect of wearing DL on the working posture of pediatric dentists.

In pulpotomy procedures performed with DL in 23 patients and without DL in 23 patients, photographs will taken at a total of 3 times in each patient: at the beginning of the procedure, 15th and 30th minutes. The working postures of the clinicians will analyzed using the Modified-Dental Operator Posture Assessment Instrument (M-DOPAI) method through these photographs.

Eligibility Criteria:
Inclusion Criteria:

* indication for pulpotomy in the mandibular right second primary molar,
* 3 (positive)- 4 (definitely positive) according to the Frankl Behavior Scale,
* parents volunteered to participate in the study and signed the informed consent form,
* did not have any systemic disease or disability.

Exclusion Criteria:

* contraindication for pulpotomy in the mandibular right second primary molar
* 2 (negative)- 1 (definitely negative) according to the Frankl Behavior Scale
A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer

This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 18 to 75 years of age
* Locally advanced or metastatic pancreatic cancer

Exclusion Criteria:

- Prior chemotherapy for pancreatic cancer