cyrilzakka/clinical-trials huggingface dataset:
Chinese Herbal Medicine Treatment as Adjunct Therapy for Parkinson's Disease

Background: Parkinson's disease (PD) is a prevalent and debilitating condition. Conventional medications cannot control all symptoms and may inflict adverse effects. A survey reported that Chinese herbal medicine (CHM) is frequently sought. Existing CHM trials were contradictory and often of poor quality due to a lack of methodological rigor. A national clinical guideline was drafted in China with diagnostic criteria and treatment strategy of Chinese medicine (CM) patterns subgroups of PD. The suggested CHM was found to exhibit a neuroprotective effect in in vitro and in vivo studies. This trial aims to preliminarily assess the effect of CHM prescribed based on pattern differentiation on PD symptoms and patients' quality of life, and evaluate the feasibility of the trial design for a future large-scale trial.

Methods: This trial will be a pilot assessor- and data analyst blind, add-on, randomised, controlled, pragmatic clinical trial. 160 PD patients will be recruited and randomised into treatment or control groups in a 1:1 ratio. The trial will be conducted over 32 weeks. PD patients in the treatment group will be stratified into subgroups based on CM pattern and receive CHM accordingly in addition to conventional medication (ConM). The control group will receive ConM only. The primary outcome will be part II of the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Secondary outcomes will include part and total scores of MDS-UPDRS, domain and total scores of Non-motor symptom scale (NMSS). Adverse events will be monitored by monthly follow-ups and questionnaires. Mixed models will be used to analyse data by Jamovi and R.

Expected outcomes: The success of our trial will show that the pragmatic design with subgroup differentiation is feasible and can produce reliable results. It will also provide preliminary data of the effect of CHM on improving clinical outcomes and quality of PD patients. Data collected will be used to optimize the study design of the future large-scale clinical study.

Ethical clearance: Ethical clearance of this study was given by the Research Ethics Committee of Hong Kong Baptist University (REC/20-21/0206).


Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with PD according to United Kingdom Parkinson's Disease Society Brain Bank (UKPDBB) diagnostic criteria
2. aged 18 to 80 years old
3. under stable ConM treatment with no alteration of dosage in the past 30 days

Exclusion Criteria:

1. secondary PD or atypical parkinsonian disorder
2. used antidepressants in the previous month
3. with concurrent psychiatric, mood, or other neurological disorders
4. suicidal (with suicidal thoughts in the past year)
5. with concurrent severe disorders, such as cancer and myocardial infarction
6. participation in another Chinese herbal medicine clinical study
7. pregnant or breast-feeding
8. Hoehn and Yahr (H\&Y) stage 4 or above
9. liver and renal function derangement
Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions

This study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of the study is to compare the pharmacokinetics (PK) of three different prototype capsule formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be used as basis for choice of formulation for further pharmaceutical development.

To assess the relative bioavailability of the different omega-3-carboxylic acids prototype capsule formulations in relation to Epanova® capsules 1000 mg under fed and fasted conditions.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated written informed consent prior to any study specific procedures.
* Healthy male and female (non-childbearing potential) subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
* Females must have a negative pregnancy test at screening and on admission to the clinical unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:

  * Post-menopausal, defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments, and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
  * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation.
* Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influences the results or the potential subject's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Current smokers or those who have smoked or used nicotine products within the previous 3 months.
* Consumption of poppy seeds within 7 days of first administration of IMP.
* Consumption of fish within 7 days prior to admission to the clinical unit.
* Used fish oil, other omega-3 fatty acids (EPA and/or DHA) containing supplements within 1 month of admission to the clinical unit.
* Have a known sensitivity or allergy to soybeans, fish and/or shellfish.
Microneedle Versus Fractional CO₂ Laser for Skin Aging Treatment With Stem Cell Secretome in Indonesian Adult Women

Evidences regarding the effectiveness of adipose-derived mesenchymal stem cells (ADMSCs) secretome to alleviate skin aging have been extensively available, yet no studies hitherto directly investigated the best administration technique for such purpose. The objective of this study is to compare microneedling and fractional CO₂ laser methods in administrating ADMSCs secretome for facial skin rejuvenation of Indonesian adult women.

A single-blind, randomized clinical trial will be conducted upon thirty females (aged 35-59 years old) presented with signs of generalized facial cutaneous senescence. Their initial skin status will be evaluated utilizing dermoscopy photoaging scale (DPAS) and Janus-3® skin analyzer, along with skin capacitance using the Corneometer® and transepidermal water loss using the Tewameter®, followed by daily priming with 0.05% retinoic acid for two consecutive weeks. At second and fourth week, the participants are subjected to microneedle and fractional CO₂ laser according to the respective protocol in split-face fashion, which the randomization will be determined by a computer programme. Succeeding the treatment, four-fold concentrated ADMSCs secretome will be administered topically to the both sides of face. The final skin condition will ultimately be recorded at the sixth week, along with their satisfaction and convenience degree, the adverse events experienced during the trial, and subjective preference to the treatment. Appropriate statistical analyses will subsequently be performed at the significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged 35-59 years
* Generalized wrinkles on the face
* Consent for the 2-month clinical trial (4 times of follow-up with 2 weeks interval)

Exclusion Criteria:

* Prior history of hypertrophic scars or keloid formation
* Prior history of allergy to topical anesthetic and/or retinoic acid cream
* Prior history of autoimmune disorders (e.g. systemic lupus erythematosus, rheumatoid arthritis, etc.)
* Prior history of malignancies
* Prior utilization of skincare products for the past 6 months
* Currently under long-term immunosupressants medication (e.g. corticosteroids, biologic agents, cytostatics, etc.)

Drop-out Criteria:

* Pass away during the clinical trial
* Refrain from the clinical trial before the trial completion
* Absent for more than two days from the scheduled appointment
* Suffer from coronavirus disease 2019 (COVID-19) at any time during the trial
* Experience major adverse event(s) caused by topical products or treatments given in the clinical trial (e.g. allergic drug eruption or contact dermatitis). The participants will receive appropriate management if such event occurs.
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

The Investigators will measure hepatic glucose and fat metabolism in obese girls with Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) after taking 4 weeks of an essential amino acid (EAA) supplement or placebo and test whether the EAA supplement can improve hepatic glucose metabolism in these girls.

Girls with Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) will complete a 12 week double-blinded placebo controlled cross-over study with 4 weeks each of an essential amino acid (EAA) supplement and placebo, and will complete metabolic studies after each intervention. There will be a 4 week wash out period in-between. The metabolic tests after each intervention (EAA/placebo) will include an oral sugar tolerance test (OSTT) and an oral U-C13 glycerol tracer that is paired with Nuclear Magnetic Resonance (NMR) isotopomer analysis of serum samples to describe flux through the hepatic pentose phosphate pathway, tricarboxylic acid (TCA) cycle and fatty acid synthesis pathways in girls with PCOS and HS. Hepatic steatosis will be measured with magnetic resonance Imaging (MRI) and hepatic phosphate concentrations with magnetic resonance (MR) spectroscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Females
2. Ages 12-21
3. Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.
4. BMI equal or greater than the 90th percentile for age and gender
5. PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses \>24 months post-menarche and clinical or biochemical hypertestosteronemia)
6. HS per FibroScan ultrasound, with CAP score of \>225 (will be measured at screening visit)

Exclusion Criteria:

1. Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, hormonal contraception. Dermal patch or vaginal ring contraception methods.
2. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
3. Severe illness requiring hospitalization within 60 days
4. Diabetes, defined as Hemoglobin A1C \> 6.4%
5. BMI percentile less than the 90th percentile for age and sex. Weight \>325 lbs or \<84 lbs.
6. Anemia, defined as Hemoglobin \< 11 mg/dL
7. Diagnosed major psychiatric or developmental disorder limiting informed consent
8. Implanted metal devices that are not compatible with MRI
9. Use of blood pressure medications
10. Known liver disease other than NAFLD or AST or ALT \>125 IU/L
Does Pulse-triggered VNS Autostimulation Increase VNS Efficacy

This is a research study to investigate whether the use of an extra function of vagus nerve stimulator (VNS) can give an improved effect against epilepsy. Many epileptic seizures are accompanied by an increase in heart rate. One auxiliary function of a new type of stimulator is continuous measurement of cardiac activity, and when pulse rate increases an extra stimulation is delivered. It has been shown that this can interrupt attacks that are about to develop. In this project the investigators will test how well that works for patients in daily life. The new type of stimulator has similar design and location as the old one. Patients who have already been treated with VNS and who need to switch the stimulator because the battery is starting to run out, are asked whether they want to participate. The study is a randomized and blinded cross-over. The activation of the extra feature is done either in the first or the second treatment phase. Which phase is the phase with activated autostimulation will be decided by random selection and the patient does not know when the auxiliary function is started. The study period is 11 months. Patients are asked to fill in some questionnaires on seizures, quality of life and quality of sleep.


Eligibility Criteria:
Inclusion Criteria:

* Subjects, 12 years of age or older, who have a VNS without ECG-triggered auto stimulation implanted, have a positive effect and have a device replacement with model 106 or model 1000 due to low battery capacity,.
* Subjects, who have 2 or more seizure per month and not more than 28 days between seizures during the baseline.
* Subjects, who are on a stable regiment of antiepileptic drug treatment for at least 3 month prior to enrollment and maintain on this regimen throughout the study.
* VNS parameters have not been changed I the last 3 month prior to enrollment.
* Subjects which are using an off time of at least 1.8 min. (If the patient is on a duty cycle involving an off-time of 1.1 min. or less, and willing to participate in the study the duty cycle will have to be changed to fulfill the inclusion criteria as follows. The off-time will be changed to 1.8 min. and the on-time accordingly to achieve about the same duty cycle as the patient had before. If the duty cycle is above 30% the parameters will be changed to 60 sec./1.8 min., if the duty cycle is between 30% and 23% the parameters will be change to 30 sec./1,8 min., if the duty cycle is 20% the parameters will be change to 21 sec./1,8 min. and if the duty cycle is 15% the parameters will be change to 14 sec./1,8 min. After at periode of 3 month observation the patient can be included in the study.)
* Either the subjects or the legal guardian are able to agree to participate by signing the informed consent form.

Exclusion Criteria:

* Subjects with rapidly progressive neurodegenerative or rapidly progressing neoplastic disease.
* Subjects or legal guardians who are unable to understand the study procedures.
Pediatric Bipolar Registry

The goal of the Pediatric Bipolar Registry (PBR) is to provide a comprehensive assessment regarding the diagnosis and treatment of pediatric bipolar disorder to children and adolescents with any current mood state and/or children/adolescents who are offspring of a parent with bipolar disorder (BD) type I or II and their families.

Data collected will be utilized to perform a retrospective chart review to include measure outcomes and de-identified demographic information detailed in the attached case report forms. In each case where a diagnosis of bipolar disorder I, bipolar disorder II, or bipolar disorder NOS is determined, the child/adolescent will be added to the PBR and provided with information about local providers that are qualified to treat their diagnosis. Each subject can elect to be notified about future research studies s/he may qualify for. Furthermore, the investigators will provide ongoing newsletters with useful information that addresses the latest research underway in the field with the families. If requested, the investigators will provide a written report to their current provider detailing our evaluation. The potential for a breach in confidentiality always exists; however, information that is obtained will be stored in password a protected database and locked file drawers in locked offices; data will have identifying information sheered from it to prevent loss of confidentiality, and all staff must sign confidentiality certificates. If child abuse is detected, the research team is obligated to follow mandatory state reporting laws. To the investigators' knowledge, there is no registry for Pediatric Bipolar Disorder in the city of Houston or the state of Texas that provides the comprehensive evaluation that we are proposing for these children and adolescents and their families. Therefore, this will be a novel service within this division that will provide research to families and potential clients for providers managing these families across the State of Texas.

Eligibility Criteria:
Inclusion Criteria

1. Age 6-17 years old at time of initial visit.
2. Any current mood state Diagnosis of a DSM- IV Bipolar Disorder, Type I, Type II and NOS.
3. Offsprings of a parent diagnosed with Bipolar Disorder Type I or Type II.

Exclusion Criteria

1. Pervasive Developmental Disorder (PDD) (and/or PDD NOS)
2. Mental Retardation/Intellectual Disability
3. Severe Neurological Disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis).
4. Schizophrenia
5. Uncontrolled or severe medical problem
Effect of Hemodialysis Membranes on Platelet Count

The purpose of this study is to determine if there is a drop in platelet count after hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in platelets and sometimes in white blood cells. The investigators are going to study one of the membranes which is the Fresenius Optiflux® to check if it causes a drop in platelets.


Eligibility Criteria:
Inclusion Criteria:

* Patients on Hemodialysis for \>=6 months

Exclusion Criteria:

* Hematological Cancers

  * Myelodysplastic syndromes
  * Baseline thrombocytopenia
  * Acute infections (patients on antibiotics)
  * Patients with Immune thrombocytopenic purpura (ITP)/Thrombotic thrombocytopenic purpura (TTP)
  * HIV
  * Liver disease
Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).


Eligibility Criteria:
Inclusion Criteria:

* Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis
* With axial involvement
* Without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders)
* Need for daily treatment with NSAIDs during the previous 30 days before study entry

Exclusion Criteria:

* Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc)
* Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.)
* Known vertebral compression
* Need for a corset during the study
Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.

This is a prospective, multicentric open-label trial to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.

The primary efficacy outcome was evaluated with progression-free survival (PFS).

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of glioblastoma confirmed by histology
* 2. Age: 18-75 years old
* 3. Single lesion located in one hemisphere with a diameter between 2 and 6 centimeters
* 4. No prior anticancer therapy for glioblastoma besides biopsy.
* 5. ECOG PS：0-2 point

Exclusion Criteria:

* 1. Infra-tentorial tumor or tumor involves the ependymal surface.
* 2. Nonmeasurable disease.
* 3. Evidence of uncontrolled intracranial pressure.
* 4. Severe heart, brain, and lung diseases.
* 5.Severe hepatic or renal dysfunction.
* 6. Uncontrolled, active infection.
* 7. Severe clotting dysfunction.
* 8. Pregnant.
* 9. Uncontrolled hypertension.
* 10. Participated in any other clinical treatment trial within 4 weeks before randomization.
* 11. Severe vascular diseases within 6 months before randomization.
* 12. Participants who received major surgical treatment within 4 weeks or were expected to be treated during the trial.
Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

Breast cancer patients often suffer from long-term physical symptoms of weakness. In this study, investigators propose to compare how two different low intensity physical exercise training programs can improve handgrip strength for breast cancer patients with symptoms of weakness. Using brain imaging, the study will also investigate changes in brain structure, and muscle activity associated with handgrip.

Participants will be randomized to either a no treatment group or one of two low intensity 6-week exercise training. Outcomes will be measured at baseline, post-intervention and 4 weeks post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 40-75 yrs
* Right handed, as determined by the Edinburgh Inventory (Oldfield, 1971)
* Proficient in English
* Must be available for the familiarization, and testing sessions

Exclusion Criteria:

* Symptoms for mild or severe depression as determined by a Patient Health Questionnaire (PHQ-8) score \>14
* Significant cognitive impairments as defined by a score \<28 in the Folstein Mini-Mental Screening Examination (MMSE, Folstein et al .1975).
* Participated in any type of motor imagery or strength training program in the last 5 years, or plan to start any motor imagery or physical strength training program for the 3 months duration of the study
* Neurological, psychiatric, musculoskeletal or other types of disorder that may affect participants sensorimotor function and cognitive abilities
* Current medication believed to affect cognitive/psychomotor function (i.e., opioid, analgesics, anxiolytics or antidepressants)
* History of alcohol, smoking, and drug abuse
* Any contraindication for MRI
Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older
* Growth disturbance defined as current height SDS \< -2.5 (and parental adjusted SDS \<-1) for chronological age and sex according to country specific references.
* Birth weight and/or length below -2 standard deviations (SD) for gestational age

Exclusion Criteria:

* Onset of puberty
* Closed epiphyses
* Diabetes mellitus type I or type II
* Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
* Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
* Known IGF-I level above +2SD for sex and age
* Acute critical illness
* Previous treatment with any hGH preparation
* Treatment with antidiabetic medication (e.g. metformin, insulin)
* Drug abuse, substance abuse, or alcohol abuse