cyrilzakka/clinical-trials huggingface dataset:
Causes of Peripheral Hypotonia in Assiut University Children Hospital

Hypotonia is a common manifestation in infants and children.It includes several clinical conditions that do not always lead to a favorable outcome .Thus, it is important to make early diagnosis to decide on the treatment and follow up of these cases. Hypotonia is a state of low muscle tone (The amount of tension or resistance to stretch on a muscle), often pointing to reduced muscle strength.

Hypotonia is not a specific medical disorder, but a potential manifestation of several diseases and disorders, that affect motor nerve control by the brain or muscle strength.

Criteria of peripheral hypotonia are : absent or depressed tendon reflexes , failure of movements on postural reflexes ,fasciculation with or without muscle atrophy .A sequential scheme of localization would begin with the anterior horn cell (AHC), and progress to the peripheral nerve , neuromuscular junction (NMJ) and the muscle itself.

Electroneuromyography (ENMG) provides useful information on many neuromuscular diseases. In addition nerve conduction study is also helpful to identify the most common peripheral disorders causing hypotonia in these children.

The initial approach to hypotonia is to determine whether the problem is due to central or peripheral origin.This is of crucial importance when forming a plan for diagnostic investigations and management.

Many muscle diseases share common clinical features that may lead to laboratory diagnosis by using enzyme levels that are affected in some of these diseases(e.g creatine phosphokinase ). However the use of serum creatine phosphokinase level may not possibly differentiate between various muscle diseases . The selective involvement of certain muscles is a key to the diagnosis of muscle disease\].

High resolution ultrasound allows visualization of the muscle, nerve and adjacent structures and can offer real-time information regarding neuromuscular diseases. It can be used as a helping tool to electrodiagnosis with estimation of the serum creatine phosphokinase levels of these cases.

The aim of this work :is to give a profile of the causes of peripheral hypotonia in infant and children attending Assiut University Children Hospital during one year of the study .

Besides full clinical assessment of the cases including birth history , developmental history, age, sex, and duration of illness as well as age of onset of observed weakness will be recorded. Full neurological examination will be done in all cases .Cases will have serum creatine phosphokinase levels, electromyography and nerve conduction studies done as indicated.Cases will also have real time muscle ultrasonography done.

* Our results will be compared with the results obtained by other investigators .
* Statistical analysis : correlation studies will be done between the various methods of investigations used .Chi2 test will be used to indicate the prevalence of the various causes of hypotonia found in the study .

Eligibility Criteria:
Inclusion Criteria:

* all infant and children with peripheral hypotonia

Exclusion Criteria:

* central causes of hypotonia
Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers

The objective of the study is to assess the PK, safety and tolerability of a single dose of mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.

A single group of patients will receive both mirabegron alone and in combination with rifampin

Eligibility Criteria:
Inclusion Criteria:

* Weighs at least 45 kg and body mass index (BMI) between 18 and 32 kg/m2 at Screening
* Normal or not clinically significant 12 lead ECG and clinical laboratory test results at Screening
* Female subjects must be post-menopausal, surgically sterile since at least 1 month prior to screening, or practicing effective non-hormonal contraceptive methods. All females must be non-lactating, and should have a negative result for the pregnancy test at Screening and on Day -1
* Negative drug and alcohol screens

Exclusion Criteria:

* Has known or suspected hypersensitivity to mirabegron or rifampin
* Liver enzyme test abnormalities (ALT, AST, or bilirubin) above the upper limit of normal
* History or presence of psychiatric illness, serious active or recurrent infection or hepatitis
* Previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the dose of study drug
* Donation or loss of ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
* Received or is anticipated to receive a prescription drug within 14 days prior to Day -1 or within 30 days prior to Day -1 for any long acting treatments. Use of any over-the-counter medications, including complementary and alternative medicines (except for occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days prior to Day -1
* History of substance abuse within 6 months prior to Screening
* Current participation in another clinical trial or is taking or has been taking an investigational drug in the 30 days or 10 half lives of the drug, whichever is longer, prior to dosing
* Known to have hepatitis or HIV-1 and/or HIV-2 or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody at Screening
* Subject has consumed alcohol, caffeine-containing food or beverages, grapefruit juice, grapefruit-containing products or Seville oranges within 48 prior to Day -1
Shoulder Proprioceptive Training During Immobilization of the Wrist

The goal of this randomized clinical trial is to compare how a program of proprioceptive exercises for the shoulder could influence in pain, functionality, quality of life and shoulder muscle overload in people that are undergoing a immobilization period after a wrist fracture. The main questions it aims to answer are:

* Study the relationship between shoulder muscle overload and shoulder pain.
* Evaluate the effect of a proprioceptive program on pain and patient's satisfaction.

Intervention will be:

* Control group: participants of this group are not going to receive any protocol of exercises during the immobilization period.
* Experimental group: participants of this group are going to receive a protocol of proprioceptive shoulder exercises to do during the immobilization period.

Researchers will compare control and experimental group to see if a implantation of a proprioceptive program for the shoulder has benefits on pain, function, quality of life and muscle overload.

Distal radius fracture (DRF) in one of the most frequent injuries in the upper limb, corresponding to 1/6 of the total fractures of the body. It appears mostly in \>50 years old women (due to osteoporosis and menopause) but it is also frequent in middle age men as a consequence of a big trauma during sport activities or working. This injury can be treated conservative of surgically, but regardless of the treatment, it always has a period of immobilization between 3 to 6 weeks.

During the immobilization period, proximal structures suffer changes in mobility. Shoulder's ROM has to increased in order to compensate the immobilization of the wrist. Previous studies shown that there is a relation between time of immobilization and shoulder pain.

Shoulder pain can significantly affect daily living activities as driving, dressing or even eating. Also, pain does not appear only on it's own, but with other psychological factors as catastrophism, lower self-efficacy, fear of movement and avoidance. These factors could be crucial to predict disability in these patients, hence they should not be ignored during the rehabilitation process.

Our hypothesis is that the implementation of a proprioceptive shoulder exercise program during the period of immobilization may help and/or prevent shoulder pain secondary to immobilization.

Eligibility Criteria:
Inclusion Criteria:

* Adult (equal or more than 18 y/o).
* Suffering a distal radius fracture and being in the first week of the immobilization period.
* Agree and sign informed consent.

Exclusion Criteria:

* Not had suffered a distal radius fracture and/or not being on the immobilization period.
* Suffer any mental, cognitive, neurological or musculoskeletal disorder.
* Previous injury or pathology of the shoulder diagnosed as fractures, instability, shoulder pain or capsulitis.
* Previous shoulder surgery.
* Have cervical pathology/impairment.
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase

To select the best dosage of tenecteplase for acute ischemic stroke patients (onset time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with anterior circulation acute ischaemic stroke
2. Time from onset to treatment 4.5h-24h
3. Patient's age is ≥18 years
4. Pre-stroke mRS score of \<= 2
5. Clinically significant acute neurologic deficit
6. Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
7. Multimodal CT/magnetic resonance imaging: perfusion lesion volume (DT \> 3 s) to infarct core volume ratio (rCBF\<30% or diffusion-weighted imaging lesion) \>1.2, absolute difference \>10 ml, and ischemic core volume \<70ml
8. Informed consent was obtained from patients.

Exclusion Criteria:

1. Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
2. Rapidly improving symptoms (patient with an NIHSS score decrease to \< 4 at randomization)
3. Pre-stroke mRS score of \> 2
4. Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
5. Infarct core \>1/3 middle cerebral artery (MCA) territory
6. Platelet count \< 100x10\^9/L
7. Symptoms were caused by low blood glucose \< 2.7 mmol/l
8. Severe uncontrolled hypertension, i.e. systolic blood pressure \>= 180 mmHg or diastolic blood pressure \>=100 mmHg
9. Current use of warfarin with a prolonged prothrombin time (INR \> 1.7 or prothrombin time \> 15s)
10. Use of low molecular weight heparin within 24 hours
11. Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
12. Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
13. Arterial puncture at noncompressible site in previous 7 days
14. Major surgery in previous 14 days which poses risk in the opinion of the investigator
15. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)
16. Significant head trauma or prior stroke in previous 3 months
17. History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
18. Hereditary or acquired haemorrhagic diathesis
19. Active internal bleeding
20. Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
21. Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
22. Pregnancy
23. Various dying diseases with life expectancy ≤3 months
24. Other conditions in which doctors believe that participating in this study may be harmful to the patient
25. Patients participated in any observational trial in 30 days
26. Allergic to the test drug and its ingredients
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 65 years of age
* Chronic HBV infection
* Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg

Exclusion Criteria:

* Seropositive for HIV, HCV, or HDV antibody at Screen
* Previous treatment with any investigational HBV antiviral treatments within the last 6 months
* Other known cause of liver disease, including NASH
* Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention
The Oxygenation of the Brain During Caesarean Section

The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women
* Over 18 years old
* ASA 1-2
* Undergoing elective caesarean section
* Height over 160 cm or under 180 cm

Exclusion Criteria:

* Allergic reactions to ephedrine or phenylephrine
* High blood levels of bilirubin
* HELPP syndrome
* Preeclampsia (pregnancy-induced hypertension)
* Non singleton pregnancies
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency


Eligibility Criteria:
Inclusion Criteria:

* Subjects with vitamin D deficiency

Exclusion Criteria:

* Subjects who experienced a hypersensitivity to the cholecalciferol
* Subjects with Hypercalcemia
* Subjects with Hypercalciuria
* Subjects with renal impairment
* Subjects with calcium stone
* Subjects diagnosed with sarcoidosis or pseudo-hypoparathyroidism
* Subjects who are to take vitamin D supplements during the study period
Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer

To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.

This is an open-label, multi-center, randomized, Phase 3 study designed to compare the efficacy and safety of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.

Eligibility Criteria:
Inclusion Criteria:

1. The presence of metastatic pancreatic adenocarcinoma
2. Measurable disease per RECIST v.1.1
3. Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
4. Eastern Cooperative Oncology Group Performance Status of 0 - 1
5. Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
6. Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
7. Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
8. No peripheral neuropathy
9. No known history of dihydropyrimidine dehydrogenase deficiency

Exclusion Criteria:

1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
2. Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
3. Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen
4. Participants who were intolerant of a gemcitabine containing regimen.
5. History of positivity for human immunodeficiency virus
6. Chronic active or active viral hepatitis A, B, or C infection
7. Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
8. Pregnant or lactating women
9. Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
10. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
11. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
12. Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1
Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients

This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in high responders.

The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in patients with expected high response to ovarian stimulation.

Multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation.

PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once thawed, the embryos are cultured to the blastocyst stage before transfer.

In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. PTEC ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw).

The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Female patient 18 to 40 years of age seeking their first IVF treatment.
2. Cycle day 3 FSH less than 10.0 IU/l.
3. More than 15 antral follicles observed on ultrasound.

Exclusion Criteria:

1. Failure to follow the protocol.
2. Embryo biopsy.
3. Any prior IVF cycle(s).
Validation in Humans of Genes Involved in Alcohol Drinking, Stress-Induced Alcohol Drinking and Relapse

Aim of the project is to validate and functionally characterize the combined impact of candidate genes and stress exposure on drinking in adolescents. Lifetime and recent stress experiences and drinking are recorded in a sample of healthy young adults who are genotyped for polymorphisms in candidate genes related to alcoholism. All participants undergo a standard laboratory psychosocial stress test. Our hypothesis is that specific genes can be identified which influence drinking by modulating stress response.


Eligibility Criteria:
Inclusion Criteria:

* All 18 or 19 year old participants of the Mannheim risk children study, i.e. a longitudinal birth cohort study that started in 1986 and had the inclusion criteria given below:
* Male and female singletons, firstborn to their mothers between February 1st, 1986 and February 28th, 1988, consecutively recruited from 2 obstetric and 4 children's hospitals of the Rhine-Neckar region, Germany.
* with no severe physical handicaps, obvious genetic defects, or metabolic diseases.
* with German-speaking Caucasian parents.
* Falling into one of 3 predefined groups with absent, moderate or high pre- and perinatal risk, operationalized by low gestational age at birth, low birth weight, and severity of the following: Preterm labor, EPH-gestosis, perinatal asphyxia, seizures, respiratory distress syndrome, perinatal sepsis.
* Falling into one of 3 predefined groups with absent, moderate or high psychosocial risk, operationalized by a family risk index measuring the presence of 11 adverse family factors covering characteristics of the parents (e.g., psychiatric disorders), the partnership (e.g., disharmony), and the family environment (e.g., overcrowding)during a period of one year prior to birth.

Exclusion Criteria:

* Intelligence quotient or motor quotient below 70, or presence of severe neurological disorder such as infantile cerebral palsy, at age 15.
* Women with known pregnancy.
* Any physical of psychiatric disease requiring treatment
* Incapable to give informed consent or to answer questionnaires in writing
* Recent use of illegal drugs
The Peer Support Study

Competent family caregivers (FC) are essential for successful caring for individuals with NMD. However, family caregiving is known to contribute to significant FC burden and social isolation, and negatively affects FC health. Infrastructure to support FCs is paramount to ensure that individuals with NMD can safely remain at home. Individuals with NMD have complex health problems, require a lot of care and they use the healthcare system often. COVID-19 physical distancing has increased the care burden and social isolation for many FCs. Infrastructure to support FCs is paramount to ensure that individuals with NMD can safely remain at home. Peer support includes emotional and informational support by an individual that has experienced a similar health problem. It improves health-related quality of life, increases self-efficacy and empowerment, and decreases stress in various patient and caregiver populations. With our study we plan to educate and empower individuals with NMD and their caregivers and develop a comprehensive peer support program.


Eligibility Criteria:
Eligibility Criteria for Peer-Support Program:

Inclusion Criteria

1. FC of individual with NMD that lives in Canada;
2. Speaks and reads English;
3. Access to internet and computer/tablet.

Exclusion Criteria:

We will exclude those Ventilator Assisted Individuals (VAI) and caregivers, who are:

1. Unable to communicate verbally in English
2. No access to internet and computer/tablet.

Eligibility Criteria for Peer Mentors:

Inclusion Criteria:

1. Criteria 1-3 above;
2. Completion of virtual peer support training;
3. Identified by the HMV team or self-referral.

Exclusion Criteria:

We will exclude those VAIs and caregivers, who are:

1. Unable to communicate verbally in English
2. No access to internet and computer/tablet.