cyrilzakka/clinical-trials huggingface dataset:
Aripiprazole IM Depot for Chinese Patients With Schizophrenia

This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.

In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug.

In this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
3. subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.

Exclusion Criteria:

1. Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR;
2. Score of Positive and Negative Syndrome Scale (PANSS): ≥120;
3. Patients with a complication or a history of diabetic mellitus;
4. Subjects who are alcoholemia overdependent of drug, or have drug abuse history;

Other protocol-defined inclusion and exclusion criteria may apply.
Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline

This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS) to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and FACE-Q instrument

A prospective, open label study, in which both right and left jawlines will receive treatment with Radiesse (+). Subjects will be randomized in a 2:1 ratio to either a treatment group or an untreated control group. Jawlines will be assessed by masked evaluators on the MJGS. Treating physicians and treatment group subjects will assess satisfaction on the GAIS. Treatment group subjects will self-report aesthetic outcomes on the FACE-Q instrument.

Treatment subjects will be evaluated at enrollment, and 1, 2 and 4 weeks after enrollment. Control group subjects will be required to be evaluated at enrollment and 4 weeks after enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Has right and left jawlines with moderate to severe volume/contour loss as determined by a live, masked evaluator.
2. Is at least 18 years of age.
3. Understands and accepts the obligation not to receive any other procedures below the orbital rim including the neck during participation in the study.
4. Understands and accepts the obligation and is logistically able to present for all scheduled study visits and meet all study requirements.

Exclusion Criteria:

1. Has ever been treated with silicone, PMMA (polymethyl methacrylate), fat injections, poly-L-lactic acid (PLLA; Sculptra®) or permanent dermal fillers below the orbital rim including the neck.
2. Has had surgery on the jawbone or has surgical permanent implant to the face or neck.
3. Has bruxism, masseter muscle hypertrophy or asymmetry of masseter muscles, active temporomandibular joint (TMJ) disease or disorder, or active periodontal disease.
4. Has any medical condition with the potential to interfere with the study or increase the risk of adverse events.
5. Has undergone oral surgery recently or plans to undergo oral surgery procedures during participation in the study.
VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Delayed clamping of the umbilical cord (DCC) has been shown to have some benefits for preterm infants. Initiation of breathing before cord clamping is also thought to be beneficial. Since some preterm infants do not breathe well on their own immediately after birth, assisting ventilation during delayed cord clamping might have additional benefit beyond DCC alone. "VentFirst Pilot" will assess feasibility and safety of assisting ventilation of preterm infants during 90 seconds of DCC which is essential before proceeding to a randomized clinical trial.

Mothers expected to deliver an infant at 24-32 completed weeks' gestation will be approached for consent. When the infant is delivered, members of the neonatology team will be at the mother's side and will provide initial steps of resuscitation (position, suction, stimulate) per guidelines of the Neonatology Resuscitation Program (NRP). At 30 seconds after birth, the infant will receive continuous positive airway pressure (CPAP) if breathing well, or positive pressure ventilation (PPV) if not breathing well. At 90 seconds, the umbilical cord will be cut and the remainder of the resuscitation and stabilization will be carried out in the usual location.

Eligibility Criteria:
Inclusion Criteria:

- 24 0/7 to 32 6/7 weeks gestation at birth

Exclusion Criteria:

* major congenital anomalies
* monochorionic twins
* twin-twin transfusion syndrome
* hydrops fetalis
Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis

This study is to evaluate the correlation between muscle atrophy (MA), sagittal alignment, and stenosis degree in patients with lumbar spinal Stenosis (LSS). From existing radiological images, specific radiographic parameters will be extracted. General Information (Age, sex, levels of stenosis, duration of symptoms) will be extracted from patient files.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of degenerative lumbar spinal stenosis
* Upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral head
* MRI of the lumbar region with clear visibility of different muscle atrophy grade
* Consent that health related information can be used for research was signed

Exclusion Criteria:

* Other spinal disease such as severe scoliosis, fracture, spondylolisthesis and ankylosing spondylitis.
* Neuromuscular diseases such as M.Parkinson or multiple sclerosis
* Previous surgery of the spine
* Infection and/or malignancy tumor with involvement of the bony or soft tissue structures of the spine
* Presence of a documented consent dissent.
Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family Based and Metacognitive Approach

The goal of this study is to evaluate the treatment effects of an integrated treatment called Family-based and Metacognitive therapy for patients with Anorexia Nervosa. In addition, we will evaluate if an active follow-up of the patients will reduce the number of relapses, which is common during the 1 year after discharge. Fifty patients aged 12-18 years old and their parents will be invited to participate in this study and all will receive the same treatment but be randomly allocated to different follow-up conditions. The active follow-up includes 3 sessions of Metacognitive therapy and the passive follow-up includes ordinary follow-up, with no booster sessions. The patients will be assessed at baseline, pre-treatment, post-treatment, and at 6 and 12 months follow-up.

The study is an evaluation of a new approach to treating Anorexia Nervosa (F.50.0 and F 50.1) called Family-based and Metacognitive therapy. The treatment integrates both family-based work approach, where the parents learn to be in control of the meal situation and communicate better with their child. The metacognitive treatment approach, is targeting the child to work with its problems with emotional regulation and self-esteem issues, but also their attitudes to body and weight. Our aim is to both address what the overall effect of the treatment will be, but also to test if an active follow-up after discharge will lead to reduced relapse rates in the 12 months after treatment. We will apply the same approach to all included patients (A-B design), but the patients and their parents will be allocated to one of two different conditions for follow-up. The active follow-up involves receiving 3 sessions of metacognitive therapy, whereas the other group gets ordinary follow-up, with no sessions of MCT. All patients are assessed at baseline, pre-treatment, post-treatment, and by 6 and 12 months follow-up. The purpose of the design is to evaluate if the rate of relapse during the first year after discharge can be reduced

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of F 50.0 and F 50.1

Exclusion Criteria:

* Psychotic symptoms
* Severe somatic illness
* Mental retardation or developmental disorder
* Bipolar disorder
* Extreme self-mutilation or acute suicidal risks
* Does not speak or understand Norwegian
Clinical and Immunological Features of the CMV Infection Atypical Course in Immunocompetent Individuals

Current study evaluates possible correlations between the content of various cell populations, the genetic material of the virus and antibodies to it in the blood of patients and the risk of thrombosis development in patients with acute CMV infection.

А new method for the early detection of immunological and clinical signs of thromboembolic complications of CMV infection in immunocompetent individuals and the treatment of patients in this category will be developed.

* evaluate the immune status main indicators that characterize the activation of immune system, immunosuppression and anergy (myeloid suppressor cells, T-regulatory cells, T-cells according to the stages of differentiation (naive - effector - memory), activated T-cells);
* identify and characterize immunological disorders in patients with CMV infection complicated by thromboembolism of various localization;
* determine the presence and quantitative content in plasma / serum and neutrophils of the CMV genetic material by real-time PCR;
* study humoral immunity to CMV (IgM / IgG antibodies to CMV in serum);
* determine the content of CMV specific T-cells in peripheral blood;
* develop a method for the early detection of immunological and clinical signs of thromboembolic complications of CMV infection in immunocompetent persons and treatment of patients in this category.

Eligibility Criteria:
Inclusion Criteria:

* age 18 - 80 years;
* fever of not clear etiology
* confirmed CMV infection

Exclusion Criteria:

* HIV infection
* taking hormones, cytostatics;
* drug addiction
* malignant neoplasms over the past 5 years.
* active viral hepatitis or liver cirrhosis;
* immunosuppressive conditions of any etiology
Personalized Antisense Oligonucleotide Therapy for A Single Participant With CHCHD10 ALS

This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in CHCHD10

This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single participant with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in CHCHD10

Eligibility Criteria:
Inclusion Criteria:

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.
* Genetically confirmed neurological disorder.

Exclusion Criteria:

* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures.
* Use of an investigational medication within less than 5 half-lives of the drug at enrollment
Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon

The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.

Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients.


Eligibility Criteria:
Inclusion Criteria:

* secondary Raynaud's phenomenon

Exclusion Criteria:

* primary raynaud phenomenon
* active infection
* hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB)
* elevated AST/ALT (3 times above the upper normal limit)
* severe renal failure
* patients on nitrite or nitric oxide (NO) donor treatment
* recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery
* hypotension (less than 90/50 mmHg) or uncontrolled hypertension
Conservative Treatment for Hip Osteoarthritis

The purpose of the study is to evaluate the effect of manual treatment and a patient education programme for patients without indication for hip surgery.

Hip osteoarthritis (hip OA) is the second most common arthritis of the larger joints and may result in pain and disability and lead to reduced quality of life (QoL). The prevalence of hip OA, in the adult population, \> 35 years, is estimated to 4-11% in the western society. In specific countries hip OA affects up to 25% in adults \> 60 years. With a growing elder population, these prevalence rates will increase and the demand for cost-effective and safe interventions will increase as well.

International guidelines, 2008, on the management of hip and knee OA recommend a combination of non-pharmacological and pharmacological treatment. For years the majority of interventional research for hip and knee OA has focused on surgery and drugs. Surgery is an option, when pain and disability have reached severe levels, and an increasing group of patients are today looking for other treatment options than drug treatment (pharmacological). In the last 4-6 years, new randomized controlled trials (RCT) have shown promising results with non-pharmacological treatment, such as exercise, patient education, manual therapy and acupuncture.

The purpose of this RCT is to investigate the effect of combining manual treatment and a patient education programme and compare it to a minimal intervention in form of a home stretching programme. It will further investigate the specific effect of manual treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients referred from general practitioner, chiropractor or orthopaedic surgeon
* unilateral hip pain of minimum 3 months' duration
* radiology criteria for hip OA: joint space width (JSW) \< 2.0 mm or a side difference in JSW of \> 10%
* adequate mastering of the Danish language to complete instructions and questionnaires

Exclusion Criteria:

* inflammatory joint disease
* previous hip or knee alloplastic
* secondary arthritis due to hip fracture or infection
* bilateral hip pain
* hip dysplasia with a CE angle \> 25 degrees and an AA angle \> 10 degrees
* low back pain which dominates over the hip pain
* malignant disease
* patients with paresis or paralysis after neuromuscular, cerebrovascular or polyneuropathic disease
* hip pain resulting from labral tear, bursitis and/or snapping hip syndrome
* polyarthritis
* received manual treatment for the hip within the last year
Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D

Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Patients with 25-OH vitamin D insufficiency
* Elevated alanine aminotransferase level
* Diagnosis of definite or possible steatohepatitis (NASH)

Exclusion criteria:

* Cirrhosis, present liver disease other than NASH
* Serious diseases limiting life expectancy,
* Breast-feeding or pregnant women
* Unhealthy alcohol consumption
* Drug abuse or substitution therapy
* Use of vitamin preparations within the previous 6 months and during the study
* Weight loss \>5% within 12 months before study entry
* Newly diagnosed Diabetes mellitus requiring medical treatment within 12 months before study entry
* Use of anti-obesity drugs
* Previous or current hypercalcemia
* Chronic renal disease
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy

The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).


Eligibility Criteria:
Inclusion criteria:

1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)
2. Child gestational age ≥ 37 completed weeks
3. Child aged ≥ 60 days and less than 36 months at enrollment
4. Documented IgE-mediated CMPA no more than 6 months prior to enrollment
5. Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
6. Child's parent(s) and LAR (if applicable) is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol

Exclusion criteria:

1. Child is exclusively breastfed
2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies
3. Congenital heart disease or treatment by B-blockers
4. Major gastrointestinal disease / abnormalities (other than CMPA)
5. Known or suspected soy allergy
6. Glucose-galactose malabsorption
7. Immunodeficiency
8. Children who are unable to discontinue antihistamine use (excluding eye drops) within 7 days prior to a food challenge and oral steroid use within 14 days prior to enrollment
9. Persistent wheeze or chronic respiratory disease
10. Severe uncontrolled eczema or urticaria
11. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas
12. Child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the child inappropriate for entry into the study
13. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
14. Child's parents have not reached legal age of majority (18 years).
Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults

This trial studies how well Quit4Health intervention works in supporting smoking cessation and preventing smoking initiation in young adults. Quit4Health intervention may help young adults learn more about the risks of tobacco use and may help them to quit smoking.

PRIMARY OBJECTIVES:

I. To evaluate whether smokers randomized to Quit4Health are more likely to quit smoking and remain tobacco-free at 6 months than subjects randomized to the education only control group.

II. To evaluate whether non-smokers who are randomized to Quit4Health are less likely to initiate tobacco usage and remain tobacco-free at 6 months than non-smokers randomized to the education only control group.

SECONDARY OBJECTIVES:

I. To evaluate whether well-established predictors of susceptibility and barriers to cessation (e.g. self-efficacy, knowledge about associated risks, normative beliefs, attitudes, resistance skills, peer pressure) and recently identified predictors of tobacco use (e.g., depression, nicotine dependence, alcohol use, risk-taking propensity) will mediate the effect of the intervention on both onset (for non-smokers) and cessation (for smokers) of tobacco use.

II. To evaluate whether, at the end-of-treatment (EOT) assessment, participants (both smokers and non-smokers) in Quit4Health will report a significantly better perception of Quit4Health (message relevance, tailoring to specific needs based on tobacco use status, motivation to quit, etc.) compared with their counterparts in the education only control arm.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.

GROUP II: Participants read an educational booklet about cigarettes and other tobacco products for 1 month.

After completion of study, participants are followed at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Be enrolled in at least one class at Houston Community College (HCC) Central campus, West Loop campus or Spring Branch campus (cessation and prevention/advocacy groups)
* Speak and read English (cessation and prevention/advocacy groups)
* Own an Android or iOS smartphone (cessation and prevention/advocacy groups)
* Provide current and relevant contact information (cessation and prevention/advocacy groups)
* Smoked at least one cigarette (or more) in the past 30 days (cessation group)
* Have data and wifi capabilities on their mobile device (cessation and prevention/advocacy groups)
* Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale (prevention/advocacy groups)

Exclusion Criteria:

* People who score 16 or above on the Center for Epidemiologic Studies Depression (CESD) thus showing evidence of major depressive disorder (cessation and prevention/advocacy groups)