cyrilzakka/clinical-trials huggingface dataset:
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3

This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.

Primary objective of this study will be to evaluate the safety and tolerability of APB-R3 following intravenous (IV) administration of single ascending dose in healthy participants.

The study will consist of 5 planned cohorts (1 cohort per dose level) for a total of up to 31 participants. Cohorts 1 and 2 will include 5 participants each (3 participants receiving the active and 2 participants receiving the placebo). Cohort 3 to Cohort 5 will include 7 participants each (5 participants receiving the active and 2 participants receiving the placebo).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, non-smoker, 18 to 60 years of age (both inclusive),
2. Healthy as defined by:

   1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator.
   2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease in the opinion of the investigator.

Exclusion Criteria:

1. Abnormal finding at physical examination
2. Evidence of clinical significant hepatic or renal impairment
3. Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or positive test results for COVID-19, or QuantiFERON®-TB test at screening.
4. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
Neurochemical, Metabonomics and Neuroimaging Characterization of TCM Diagnostic Subtypes of Major Depression Disorder

There is heterogeneity in patients with depression. Many scholars propose that individualization of antidepressant achieves better outcomes. However, the scientific theoretical basis of individualized treatment is still quite weak. Different clinical subtypes of depression and their possible biomarkers are critically needed to provide the individualization with theoretical base. Diagnostic types of major depression disorder (MDD) based on the Theory of Traditional Chinese Medicine (TCM) and possible differentiations in neurobiochemistry, metabonomics and neuroimaging could be one of ways to explore the biomarkers and support the theory of the individualized treatment.

The hypothesized results will be of help to clarify the biological basis of MDD with LDQS and with DBHS, to provide the TCM with further scientific evidence, to explore the pathogenesis of depression, to improve the objective diagnosis of depression, and to promote targeted interventions by Western medicine, TCM or both.

The objectives of this study is to explore if there are any differences in neurobiochemistry, metabonomics and neuroimaging (1) at the baseline, between the subjects who are the normal controls (C Group) and who both meet diagnostic criteria of the Diagnostic and Statistical Manual of 5th edition (DSM-V) on MDD and TCM criteria of 'pattern of Liver Depression and Qi Stagnation (LDQS)' or'pattern of Deficiency of Both Heart and Spleen (DBHS)' (T Group); (2) at the baseline, between the MDD subjects of LDQS and DBHS; (3) after 6-week venlafaxine administration, between the MDD subjects of LDQS and DBHS. 50 subjects in T Group and 25 in C Group are recruited in the study and the main laboratory tests include High Performance Liquid Chromatography(HPLC), Gas Chromatography-Mass Spectrum(GCMS) and neuroimaging DTI technology.

Eligibility Criteria:
Inclusion Criteria:

1. Had a diagnosis of major depressive disorder according to DSM-V and TCM criteria of 'pattern of Liver Depression and Qi Stagnation (LDQS)' or'pattern of Deficiency of Both Heart and Spleen (DBHS)
2. The severity of the symptoms is moderate or severe, confirmed by a 35 or greater of Hamilton Rating Scale for Depression(HAMD) score
3. Absence of brain and/or severe physical diseases
4. 18-65years old

Exclusion Criteria:

1. In pregnancy，brain and other severe medical conditions
2. Psychoactive substance abuse
3. Had a diagnosis of bipolar disorder
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women

The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Body mass index (BMI) of ≥ 18.5 to \< 32.

Exclusion Criteria:

* History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas
* History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
* History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
* Surgery within 3 months prior to Day 1 (other than minor cosmetic or dental procedures).
* Fever or symptomatic viral or bacterial infection within 7 days prior to Day 1.
* Donation or significant loss of blood within 2 months prior to Day 1.
* Hormone replacement therapy within 3 months prior to Day 1.
* Treatment with erythropoiesis stimulating agents (Epogen, Procrit, Aranesp, etc) within 2 months prior to Day 1.
* Systemic glucocorticoid therapy within 6 months prior to Day 1.
* Treatment with another investigational drug or approved therapy for investigational use within 1 month prior to Day 1.
* Previous treatment with ACE-031.
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.

To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.

Subjects who completed the 24-week assessment period and achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) at Week 24 of study ALX0061-C201 were invited to participate in an open-label extension (OLE) study ALX0061-C203 (NCT02518620), if the study was approved in their country and selection criteria were met.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA for at least 6 months prior to screening, and American College of Rheumatology (ACR) functional class I-III
* Subjects treated with and tolerating MTX
* Active RA
* Others as defined in the protocol

Exclusion Criteria:

* Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX.
* Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening.
* Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs, for RA.
* Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
* Others as defined in the protocol
An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency.
* Have received FCH (Haemocomplettan® P or RiaSTAP®) for treatment of bleeding, surgery or prophylaxis.

Exclusion Criteria:

None
Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China

Data on neonatal GBS disease are very limited in China. Acceptance and implementation of prevention measures such as antibiotics prevention or vaccination against GBS disease would require robust data. This study as the first national, multicenter study to investigate the epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to appraise the necessity of appropriate interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid.
2. ≤90 days old at the time of GBS confirmation.
3. Voluntary written informed consent provided.

Exclusion Criteria:

1. None
Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.

This multicentre phase IIb clinical trial will target patients from 1-17 years with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.

Eligibility Criteria:
Inclusion Criteria:

* Age: \<12 years of age
* Deep partial thickness and/or full-thickness burns requiring surgical wound coverage
* Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. \>20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion.
* Signed Informed consent

Exclusion Criteria:

* Patients tested positive for HBV, HCV, syphilis or HIV
* Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
* Severe drug and alcohol abuse
* Patients with a known history of malignancy
* Pre-existing coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN prior to the current hospital admission and / or at the Investigator's discretion
* Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
* Previous enrolment of the patient into the current phase II study
* Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
* Patients or parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
* Pregnant or breast feeding females
* Suspicion of child abuse
* Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands)
* Enrolment of the Investigator, his/her family members, employees and other dependent persons
Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients

This is an out-patient based prospective, multi-centre, observational post-marketing surveillance study amongst internists and cardiologists. In this study, patients with essential hypertension and at least one additional risk factor will be included. Patients may take any antihypertensive treatment which is approved for cardiovascular protection including Micardis 80 mg / Micardis Plus. Patients will be followed over one year in four visits from baseline to endpoint with an additional visit before and after the month of Ramadan.

Purpose:

Eligibility Criteria:
Inclusion criteria:

1. Male or female of age 18 years or older;
2. Newly diagnosed and untreated or previously treated and uncontrolled patients with essential hypertension;
3. Seated blood pressure of \>140/90 mmHg or \>130/80 mmHg in patients with diabetes mellitus or chronic kidney disease;
4. Patients with at least one cardiovascular (cv) risk factor;
5. Ability to provide written informed consent.

Exclusion criteria:

1. Patients with contraindications to the prescribed antihypertensive medications;
2. Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception;
3. Patients who are participating in any other study protocol.
Comprehensive CT-guided vs Echo-fluoroscopy-guided Strategy in the Left Atrial Appendage Occlusion

Percutaneous left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with nonvalvular atrial fibrillation (AF). Transesophageal echocardiography (TEE) and fluoroscopy were used to measure the maximal diameters of LAA. However, the LAA maximal diameters measured on Two dimensional (2D) views could be limited due to the morphology of LAA varies with each individua. Three dimension computed tomography angiography technology (3D-CTA) is based on cardiac computed tomography angiography (CCTA). The 3D-CTA technology provides an innovative measuring method of LAA to guide the selection of device size, and the best fluoroscopy view to implant device. This measuring method and guideline have never been reported and its role in LAAO is uncertain

The PERIVISION-LAAO study will be a prospective, multi-center and randomized trial designed to investigate the effect and safety of perimeter obtained by 3D-CTA versus diameter obtained by traditional echo-fluoroscopy in guidance of device size selection in the procedure of LAAO. It will enroll 310 patients with nonvalvular atrial fibrillation (AF) who will be randomized at 1:1 ratio into the perimeter guidance group or diameter guidance group. The major effect endpoint will be the success at first device selected in procedure, and the major safety outcome will be the incidence of pericardial effusion during the procedure and the follow-up period of 2 months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of atrial fibrillation Disease
* Age \>18years
* CHA2DS2-VASc scores ≥ 2
* And at least one of the following indications: (a) HAS- BLED scores ≥ 3; (b) intolerance to long-term OAC; (c) stroke, TIA or thromboembolism even under OAC treatment

Exclusion Criteria:

* GFR \<50 mL/min/1.73 m2
* Thrombus in LA and LAA
Midlevel Versus Physician-provided Medical Abortion in the Second Trimester

The purpose of the study is to determine the safety and effectiveness of second trimester medical abortion when provided by nurse midwives compared with physicians. The study sample will be obtained from Michu Clinic, affiliated with St Paul's hospital, in Addis Ababa.

About 10% of all abortions globally take place at or after 13 weeks gestation. Women seeking second-trimester abortion services are often the most vulnerable and socially disadvantaged population.Studies show the rate of second-trimester abortion procedures remains stable over time, even in high-access locations, confirming the ongoing need for accessibility to services in rural locations with limited access to care. In Ethiopia, second-trimester abortion services are widely available in Addis Ababa, making up a high proportion of the total number of abortions occurring each year in the country; however, access to accurate and reliable data is limited.

The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system (WHO abortion guidelines). Training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct second trimester aspiration abortions is proposed as a way to increase women's access to safe abortion procedures and has been highlighted by the WHO as an area in which rigorous research is needed (WHO task-sharing guidelines).

The investigators seek to conduct a comparative study of patients undergoing second trimester medical abortion provided by either physicians or nurse midwives.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give consent for participation
* Intrauterine pregnancy with confirmed gestational age \>13 weeks and \<20 weeks
* Presenting for induced abortion at Michu Clinic
* Speaker of Amharic or Oromo

Exclusion Criteria:

* Women unable to give consent for participation
* Gestational age \<13 or \>20 weeks
* Adolescents aged less than 16 years
* Women with an allergy to or contraindications to mifepristone or misoprostol
* Women with a history of more than one previous hysterotomy
* Women seeking treatment for incomplete abortion, intrauterine fetal demise, or postabortion care
* Women with chronic hypertension or adrenal failure
* Women on chronic steroid treatment
Study to Evaluate the Safety and Efficacy ofJaktinib Hydrochloride Tablets in Severe Alopecia Areata

This was an open-label, Multi-center, randomized phase Ⅱ study. Patients with severe Alopecia Areata were randomized to receive 50mg bid, 150mg qd or 200 mg qd of oral Jaktinib Hydrochloride Tablets.


Eligibility Criteria:
Inclusion Criteria:

* 18 years age or older ,male or female；
* Alopecia areata diagnosed clinically；
* Patients with alopecia accounting for 50% or more of the total scalp area and stable for at least 6 months or more；
* Patients can complete treatment for at least six months；
* Requirements for pregnant or lactating female and male and female of childbearing age；Female patients must be satisfied：Menopause (defined as no menstruation for at least one year);Or have been surgically sterilized；Or have fertility, but must satisfy：Pregnancy tests conducted within 7 days before randomization must be negative；And agree to use appropriate contraceptive methods throughout the trial period, including at least one barrier method；And no breastfeeding；Male patients must agree to use appropriate contraceptive measures throughout the trial, including at least one barrier method；
* Patients are voluntarily enrolled in the Study and can be treated and visited according to the requirements of the protocol after signing the Informed Consent Form；

Exclusion Criteria:

* Alopecia caused by syphilitic alopecia, thyroid disease, trichotilomania, head moss, connective tissue disease, infection, zinc deficiency and iron deficiency;
* Patients with acute diffuse alopecia areata (ADTAFS)
* Patients with active tuberculosis
* The following diseases were combined within 6 months before randomization:thyroid diseases ，liver diseases, malnutrition, heart diseases, nervous system diseases, gastrointestinal disorders, tumors and psychiatric diseases
* HIV positive, active hepatitis B virus positive (HBsAg or HBeAg positive) and HCV-RNA positive at screening；
* Other patients with abnormal history or clinical manifestations that may affect participants participation in the study or may confuse the results of the study；
* Within two weeks before randomization，Patients who received glucocorticoid topical therapy, anthracene ointment, minoxidil, SADBE/DPCP contact immunotherapy, photochemotherapy or cryotherapy；
* Before randomization，oral or injected any medicines to treat hair loss (including the glucocorticoids was detected in injection, systemic corticosteroids, antihistamines, stephania drugs, glycyrrhizin, glycine, methionine compound tablet, compound glycyrrhizin glucoside) and other liquorice extract, ring spore element, anti TNF antibody, IFN - gamma, IL - 2 antibodies, for alopecia areata therapy of traditional Chinese medicine and other JAK inhibitor) and washout period less than seven half-life of patients;
* Participants in a clinical trial of any drug or medical device within 4 weeks prior to randomization.
Pulmonary Rehabilitation in Interstitial Lung Disease

Interstitial lung disease (ILD) is a highly disabling group of conditions including idiopathic pulmonary fibrosis (IPF), acute and chronic interstitial pneumonias, connective tissue diseases and sarcoidosis. People with ILD frequently experience breathlessness on exertion, which limits their ability to undertake daily activities. People with ILD report very poor quality of life due to low levels of physical functioning and vitality, and high levels of breathlessness and fatigue. There are few treatments for ILD and those that are available have limited impact on quality of life.

The aim of this study is to assess the effects of Pulmonary Rehabilitation, which consists of specialised exercise training for people with lung disease, on exercise capacity and quality of life in people with ILD. We hypothesis that exercise training will result in reduced dyspnoea, improved exercise tolerance and enhanced quality of life.

Interstitial lung disease (ILD) is a highly disabling group of conditions including idiopathic pulmonary fibrosis (IPF), acute and chronic interstitial pneumonias, connective tissue diseases and sarcoidosis. People with ILD frequently experience breathlessness on exertion, which limits their ability to undertake daily activities and reduces health-related quality of life.Available treatments for ILD have proved largely ineffective, offering no improvement in survival and demonstrating only limited impact on quality of life.

Aims of the Research

1. Evaluate the effects of Pulmonary Rehabilitation on exercise capacity and quality of life in patients with ILD
2. Determine the physiological response to Pulmonary Rehabilitation in patients with ILD
3. Determine the relationship between the aetiology and severity of ILD and the effects of Pulmonary Rehabilitation.

Comparisons: 8 weeks exercise training compared to control group (maximal exercise capacity, functional exercise capacity, dyspnoea, quality of life).

Eligibility Criteria:
Inclusion Criteria:

* Ambulant
* Stable medical therapy
* Dyspnoea on exertion following maximal treatment

Exclusion Criteria:

* A history of syncope on exertion
* Too unwell to attend the hospital for exercise training
* Any other comorbidities which would prevent exercise training
* Previous Pulmonary Rehabilitation in the last 12 months