cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome

The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other half received placebo.

In China, the herbal formulas have been used in the treatment of diabetes for centuries. Huangqisan, investigators named it AMP-1915, is one of traditional Chinese herbal formula used to relieve diabetes which was recorded in Shengji Zonglu (General Medical Collection of Royal Benevolence) published in 1117 A.D. AMP-1915 consists of three herbs: Radix Astragali (roots of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, A), Mori Cortex radices (root barks of Morus alba L., M) and Puerariae Lobatae Radix (roots of Pueraria lobata (Willd.) Ohwi., P). Recent studies have shown that these three herbs and their constituents have therapeutic effects on the metabolic disorders.

This randomized, double-blind, placebo-controlled trial was conducted in a community hospital of Shanghai, China. 60 adult participants were metabolic disorder patients according with at least two impaired metabolic profiles (obesity, hyperglycemia, hyperlipidemia or others). During 3-month treatment, participants were randomly divided in to two groups assigned to take AMP-1915 or placebo. AMP-1915 or placebo was mixed into instant noodles as daily meals with same color, shape, size and packaging. BMI, fasting blood glucose (FBG), triglyceride (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c), insulin, HbA1c were measured before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Overweight (BMI \>= 20) or
* Hyperglycemia (FBG\>=6.7 mmol/l) or
* Hyperlipidemia (TG \>=1.7 mmol/l or TCH\>=5.72 mmol/l or HDL-c \<=1.00 mmol/l or LDL-c\>=3.12 mmol/l)

Exclusion Criteria:

-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
* Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
* ECOG performance status score of 0 or 1.
* Life expectancy \> 12 weeks.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

Exclusion Criteria:

* Laboratory values outside the Protocol-defined ranges.
* Clinically significant cardiac disease.
* History or presence of an ECG that, in the investigator's opinion, is clinically meaningful.
* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
* Known additional malignancy that is progressing or requires active treatment.
* Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
* Prior receipt of an anti-PD-L1 therapy.
* Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* A 28-day washout for systemic antibiotics is required.
* Probiotic usage while on study and during screening is prohibited.
* Active infection requiring systemic therapy.
* Known history of HIV
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention

The value of cytobacteriological examination of urine (CBEU) before double J catheter removal has not been demonstrated. The aim of this study is to define the interest of this CBEU.

Double J stents are ureteral catheters that allow urine to flow from the kidney without difficulty. These catheters protect the ureterovesical anastomosis of a renal transplant or reduce the postoperative oedema, for example after stone removal by ureteroscopy. These catheters are removed in an outpatient setting under local anaesthesia. Post ablation infections of double J catheters have been poorly studied but their incidence varied according to the populations and the definition used (10 to 54% for colonization, 1 to 10% for symptomatic infection). The national and international guidelines advocate a routine urine bacterial culture (UBC) before double J catheter removal as the procedure is in contact with urine; but there is no evidence of its interest. In case of positivity of this culture, it is recommended to delay the intervention or, what is more often chosen, to treat with antibiotic to cover the procedure. Investigators can thus ask 2 questions: is it rightful to withdraw a double J removal while the UBC is falsely negative and in case of a positive bacterial culture is there an increased risk of post-ablation infection?

Eligibility Criteria:
Inclusion Criteria:

* Participant ≥ 18 years of age
* Scheduled to have a double J catheter ablation
* Participants covered by or entitled to social security
* Written informed consent obtained from the participant
* Ability for participant to comply with the requirements of the study

Exclusion Criteria:

* Patients already receiving antibiotics other than urological reasons and transplanted patients
* Study interventions contraindications
* Pregnancy, breastfeeding
* Patient under tutorship or curators
* Deprivation of liberty
A Retrospective Analysis: the Influence of Caltrate Supplement on the Effect of Mesalazine in Ulcerative Colitis

Aims:Retrospectively observe the effects of Caltrate supplementation on the clinical effect of mesalazine in patients with ulcerative colitis.

Design: From January 2015 to December 2020, through retrieving the clinical database of the Second Affiliated Hospital of Wenzhou Medical University, patients with active UC who accepted mesalazine treatment were enrolled. According to whether Caltrate was supplemented at the same time, the patients were divided into supplementary group and non-supplementary group. The modified Mayo score and several laboratory indicators were compared between the two groups.

1. The research has been approved by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University.
2. According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Beijing Conference in 2018 as a standard, patients with clear diagnosis of UC are collected. Exclusion criteria included: history of vitamin D treatment within the previous 3 months; treated with glucocorticoids, immunosuppressants, biologic agents, or colectomy during the follow-up; severe liver and kidney dysfunction; other autoimmune diseases.
3. Assess disease activity of UC participants based on the "Mayo score".
4. General information about participants with UC is collected.
5. Serum C-reactive protein, erythrocyte sedimentation rate, white blood cells, albumin, creatinine, calcium and phosphorus levels are measured.
6. The level of serum 25 (OH) D of participants is detected.
7. Participants are divided into two groups, one group was given oral Caltrate 0.6g/d +Mesalazine, and the other group only took Mesalazine .
8. The above serum indicators are re-measured in the 12th month, and the condition of UC participants is also evaluated.
9. Follow-up for 12 months. By comparing the above indicators, observe that in the Han population:

   1. Can Caltrate supplementation increase serum 25 (OH) D levels in patients with UC?
   2. Can Caltrate supplementation improve the condition of patients with UC?
   3. Whether Caltrate works synergistically with Mesalazine?
   4. whether the effect of Caltrate on UC patients is affected by factors such as disease site, disease activity, treatment, etc ..
10. Through statistical analysis, comprehensive analysis of the effectiveness and safety of Caltrate supplementation in Han patients with UC, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.

Eligibility Criteria:
Inclusion Criteria:

* Clearly diagnosed patients with UC
* Took mesalazine for at least 12 months

Exclusion Criteria:

* had recent supplementation of vitD3
* had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment or follow up
* Co-morbid with other autoimmune diseases
* Severe liver and kidney dysfunction
D-Dimer Vs Serial Compression Ultrasound Study

To determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis


Eligibility Criteria:
Inclusion Criteria:

* first suspected deep vein thrombosis
* no previous venous thromboembolism
* referred to thromboembolism outpatient clinic

Exclusion Criteria:

* comorbid condition limiting survival to less than six months
* contraindication to venography (contrast allergy, etc.)
* receiving long term warfarin therapy
* receiving full dose heparin therapy for more than 48 hours
* absence of symptoms during the five days immediately prior to presentation
* symptoms of pulmonary embolism
* pregnancy
* geographic inaccessibility which precludes follow-up
C1q/TNF-related Proteins in Coronary Artery Disease

Now, adipose tissue is established as an active endocrine organ that controls systemic energy homeostasis by secretion of adipokines. Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in metabolism and inflammation. The investigators tried to clarify the relationship between CTRP family and coronary artery disease (CAD) in Korean men and women.

Adipose tissue secretes various kinds of bioactive molecules termed adipokines which contribute to the development of obesity-related disorders including cardiovascular disease (CVD). Adiponectin is the insulin-sensitizing adipokine with anti-inflammatory and anti-atherogenic properties. Hypoadiponectinemia has been associated with an increased risk of coronary artery disease (CAD) in several though not all studies. Recently, a new family of secreted proteins, C1q/TNF-related protein (CTRP), was cloned on the basis of sequence homology with adiponectin. This family of adiponectin paralogs might have pivotal implications in energy homeostasis and obesity-related inflammation. Each CTRP family member has its own unique tissue expression profile and function in regulating glucose and/or fat metabolism. In the present study, we evaluated the role of CTRP in patients with CAD and investigated whether CTRP family is significantly associated with CAD prevalence after adjustment for well-known CAD risk factors.

Eligibility Criteria:
Inclusion Criteria:

* 20\<age\<80
* History of stable angina, unstable angina, or acute myocardial infarction

Exclusion Criteria:

* a history of diabetes
* stage 2 hypertension
* malignancy
* severe renal or hepatic disease
Perioperative Cognitive Training in Thoracic Surgery

More than 30% of patients undergoing thoracic surgical procedures develop persistent post-surgical pain (PPSP), which results in impaired functioning, diminished quality of life, and increased risk of chronic opioid use. The proposed project aims to determine whether a prospective, randomized, controlled study of smartphone-based perioperative cognitive flexibility training will reduce the incidence of PPSP in high-risk individuals undergoing thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 to 75 undergoing thoracic surgery
* Access to an active email account
* Score \<50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score

Exclusion Criteria:

* Unable to complete cognitive testing
* Color blindness assessed via self-report
* Participants who do not speak or read English

The inclusion criteria for the observational cohort will be the same, with the exception of Score ≥50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score.
Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to evaluate the tolerability,safety and efficacy of OPC-415 in patients with relapsed and/or refractory Multiple Myeloma (MM).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 20 and 80 (75 for the phase 1 part) years, both inclusive, at the time of consent
* Patients with a definitive diagnosis of active multiple myeloma
* Patients who have had 2 or more prior regimens (including all proteasome inhibitors, immunomodulators, and anti-CD38 antibody)
* Patients with relapsed and/or refractory Multiple Myeloma
* Patients who are positive for MMG49 antigen
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. Those with an ECOG-PS score of 2 due solely to MM bone lesions can be enrolled
* Patients who are expected to survive for at least 3 months

Exclusion Criteria:

* Patients who are scheduled to receive high-dose chemotherapy in combination with autologous stem cell transplantation as the next treatment.
* Patients who have other active double/multiple cancers
* Patients on continuous and systemic (oral or intravenous) medication with corticosteroids or other immunosuppressive agents
* Patients with graft-versus-host disease that requires treatment.
* Patients who underwent a highly invasive and extensive surgical procedure within 2 weeks.
* Patients who previously underwent allogeneic stem cell transplantation or organ transplantation.
* Patients who underwent autologous stem cell transplantation within 90 days.
* Patients with systemic amyloidosis (except localized amyloidosis without organ derangement) or plasma cell leukemia.
* Patients with prior or current central nerve involvement in MM.
* Patients whose best ever response to MM treatment is PD.
* Patients who previously received gene therapy or cell therapy (except hematopoietic stem cell transplantation).
* Pregnant women, nursing mothers, or women with a positive pregnancy test.
Levels of Von Willebrand Factor Multimers and VWF-Cleaving Protease (ADAMTS-13) in Preterm and Neonate

Von Willebramd Factor (VWF) is an adhesive glycoprotein synthesized by megakaryocytes and endothelial cells.VWF has a central role in primary hemostasis and is a critical ligand for platelets adhesion and aggregation (1, 2).VWF is the carrier of circulating factor 8 as well. VWF is stored in Wiebel-Palade bodies in endothelial cells and in platelets alfa granules in a form of Ultra-large (UL) multimers.

The VWF multimers are composed from subunits which are linked by disulfide bonds that alternate between 2 C- terminal ends and 2 N- terminal ends in a head-to-head and tail-to-tail fashion (3, 4). The biological activity of VWF has been shown to be related to the size of the multimers.

VWF is released from endothelial cells toward the plasma as a multimers ranging from 500-20,000 kD. The UL multimers are hemostaticallly more effective than the smaller forms. They spontaneously bind to platelets which lead to the formation of microthrombi in the circulation. This mechanism is downregulated by the plasma protease ADAMTS-13(A Disintegrin And Metalloprotease with ThromboSpondin motif).If the proteolysis become defective the ULVWF will bind to platlets resulting in systemic thrombotic microangiophaties (TMA) such as thrombotic thrombocytopenic purpura(TTP)(5,6).

ADAMTS-13 belongs to the ADAMTS family of metalloproteases.The structure of ADAMTS-13 is conserved throughout vertebrates, indicating its important function (7).The metalloprotease function was first describe 11 years ago and has been cloned and characterized (8-13).The ADAMTS family of metaloploproteases is required in other systems such as genitourinary system (ADAMTS1), collagen system (ADAMTS2) and as a cleaving protease of VWF (VWFCP) - ADAMTS13. When VWF multimer is subjected to sufficient fluid shear stress ADAMTS-13 cleaves VWF at a unique 842Tyr- 843Met bond in domain A2 (14,15).This cleavage produce VWF subunit fragments of 176 kDa and 140 kDa.

The activity of ADAMTS-13 depends on both Zn+2 and Ca+2 ions (16). Low levels or deficiency of ADAMTS-13 is seen in patient with TTP(17,18). Mannuccio et al (19) showed that low levels of ADAMTS-13 are seen in other conditions such as healthy adults older than 65 years, patients with cirrhosis, uremia, acute inflammation, postoperative period. In neonate and preterm infants the data is limited. Few studies have shown that levels of ADAMTS-13 are low in neonate (19-21).Tsai et al (22) observed that ADAMTS-13 activity is normal in cord blood compared to adults. In preterm infants a pilot study showed that preterm have low levels of ADAMTS-13(23).

The aim of our study is to check ADAMTS-13, VWF multimers, VWF antigen and VWF collagen binding activity in healthy and sick neonate and in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* All infants born n our hospital between August 2007 and August 2009 will enter

Exclusion Criteria:

* Thrombocytopenia, maternal aspirin
Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama

The purpose of the study is to find out if a self-administered (by the patient) Papanicolaou (Pap) smear is as accurate as a traditional Pap smear administered by a healthcare provider.

Papanicolaou (Pap) smears will be both self-obtained by the patient and obtained by a licensed physician, nurse practitioner, or physician assistant. Specimens will then be collected by the nurse or medical assistant who will label each specimen separately. Specimens will be blinded so that the pathologist will not know which specimen was self-collected and which provider-collected. Specimens will then be sent to our clinical laboratory provider (LabCorp) for analysis. Once results from the Pap smears are received, participants will be notified in the usual manner in our clinical practice. Finally, analysis will be conducted to ascertain whether or not a self-administered (by the patient) Pap smear is as accurate as a traditional Pap smear administered by a healthcare provider.

Eligibility Criteria:
Inclusion Criteria:

* Female of at least 21 years of age and not over 65 presenting who need routine cervical cancer screening per national guidelines.

Exclusion Criteria:

* prior history of cervical cancer or a positive Pap smear, have had a total hysterectomy (removal of uterus and cervix), or currently enrolled in any other cancer prevention study.
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis

This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* Primary axillary hyperhidrosis
* Female or male, 18 years of age or older in good general health
* Excessive sweating interferes with daily life activities and scores 3 or 4 on the HDSS at Screening and Baseline
* Axillary sweat production of at least 50 mg/5 min measured gravimetrically

Exclusion Criteria:

* Any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and Myasthenia gravis
* Muscle weakness or paralysis, particularly in the upper extremities
* Active skin disease or irritation or disrupted barrier at the treatment area
* Undergone any procedures which may affect the axillary areas
* Treatment with botulinum toxin type A in the axilla in the last 9 months or anywhere in the body in the last 6 months
* Any prior axillary use of an anti-hyperhidrosis medical device
* If menopausal had symptoms of menopause such as sweating or flushing within the last year
Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects

The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA in healthy Japanese male volunteers.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be healthy male volunteers who meet the criteria below:

* Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
* Persons who are 20 or older and 35 or younger
* Persons with body mass index (BMI) of 18.5 kg/m2 or more and 25.0 kg/m2 less
* Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with the GCP (Good Clinical Practice)

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
* Prior history of jaundice
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of any drugs within 10 days prior to administration or during the trial
* Participation in another trial with an investigational product within four months prior to administration or during the trial
* Smoker (\>10 cigarettes, \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days (during hospitalisation and end of trial)
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
* Excessive physical activities (within 1 week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of the trial site
* A history of additional risk factors for torsades de pointe (e.g., heart failure, hypokalemia, and family history of long QT syndrome)
* The use of concomitant medications that prolong the QT/corrected QT interval