cyrilzakka/clinical-trials huggingface dataset:
A1 Beta-casein-free Milk in Milk-intolerant Participants

This was a single-site, double-blind, randomised, controlled, crossover study, which aimed to compare the effects of conventional cow's milk (CON, containing both A1- and A2-types of beta-casein) versus milk free of A1-type beta-casein (A1PF milk) on gastrointestinal (GI) physiology and symptoms of digestive discomfort in non-regular milk drinkers with self-reported intolerance to conventional cow's milk. The study location was the Pennington Biomedical Research Center in Louisiana, USA. The study comprised a 2-week washout period, 2 weeks of milk consumption, crossover, a second 2-week washout period, and a second 2-week period of milk consumption. Eligible participants were stratified by sex to achieve an approximate 1:1 male to female ratio and were randomised to receive conventional cow's milk (sequence 1) or A1PF milk (sequence 2) during the first period of milk consumption. During the second period of milk consumption, participant groups underwent crossover to receive the alternate study milk.

Milk was consumed three times per day after meals, with 250 mL provided at each administration. During washout periods, participants were required to avoid all dairy products and use only rice milk to replace any normal dairy intake, and to avoid foods with very high fermentable oligosaccharides, disaccharides, monosaccharides, and polyols content, to avoid potential confounding of the symptoms experienced. Any medication, nutritional supplements, dairy products, acidophilus milk, or probiotics were prohibited during the study.

The study protocol and all related documentation were approved by the Pennington Biomedical Research Center Institution Review Board. The study was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonisation. All participants provided written informed consent prior to initiating any study procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 to 68 years
* Irregularly consumed milk
* Had self-reported mild-to-moderate digestive discomfort after milk consumption
* Had normal electrocardiograms and blood pressure during quiet respiration

Exclusion Criteria:

* Known allergies to dairy products
* Severe milk intolerance
* A history of faecal impaction
* Having suffered from GI disorders (e.g., irritable bowel syndrome, colitis, ulcerative colitis, or coeliac disease)
* Currently being administered drugs for cardiovascular or metabolic disease
* Trying to lose weight by following a diet or exercise regimen
* Took any appetite or weight loss drugs for the previous three months
Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients

Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Preoperative risk assessment is important, but inexact, in older patients because physiologic reserves are difficult to measure. This also makes an important difference related to brain tumor patients, who may be burdened with systemic disease, alterations in cognition, or affected by other comorbidities. When assessing quality of life for brain tumor patients, having a better predictor of postsurgical outcome would be beneficial in appropriately counseling these patients. Frailty is thought to estimate physiologic reserves, and its use has been found to predict postoperative complications, length of stay, and discharge to a skilled or assisted-living facility in neurosurgical patients. Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Ambulatory (able to walk)
* Scheduled for neurosurgical resection of brain tumor

Exclusion Criteria:

* Parkinson disease
* Previous stroke
* Taking: carbidopa/levodopa, donepezil hydrochloride, or antidepressants
177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma)

Adults with leptomeningeal metastasis from solid tumors will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.

Part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of five 5-week cycles of treatment doses of intracerebroventricular 177Lu-DTPA-omburtamab.

Part 2 is a cohort-expansion phase in which patients will receive a treatment at the recommended dose determined in Part 1, until confirmed LM progression, unacceptable toxicity, or for maximum of 5 cycles, whichever comes first; however, the total number of cycles will be determined based upon data from Part 1 (e.g., the dosimetry data) to minimize the risk of radiation necrosis and decreased neurological function End of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. The patients will be followed for up until one year after first dose (Part 1) and 2 years after first dose (Part 2).

Eligibility Criteria:
Inclusion Criteria:

* Primary ductal or lobular breast cancer, non-small cell lung cancer, or malignant melanoma
* Type I or Type II LM with a "confirmed" or "probable" diagnosis according to EANO-ESMO guidelines 2017
* Life expectancy more than 2 months, as judged by the Investigator
* ECOG Performance status 0, 1, or 2
* Acceptable hematological status and liver and kidney function
* Written informed consent obtained in accordance with local regulations
* Presence of an intracerebroventricular access device before first dosing

Exclusion Criteria:

* Obstructive or symptomatic communicating hydrocephalus
* Progressive systemic (extra-leptomeningeal) disease
* Uncontrolled life-threatening infection
* Ventriculo-peritoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts
* Received craniospinal irradiation (for intraparenchymal or dural metastases) or intrathecal cytotoxic anti-cancer therapy less than 3 weeks prior to first dose of 177Lu-DTPA-omburtamab
* Severe non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, or gastrointestinal system toxicity Grade 3 or above prior to enrolment
* Grade 4 nervous system disorder. Hearing loss or stable neurological deficits due to brain tumor are allowed
* Unacceptable coagulation function prior to first dosing defined as INR Grade 2 or above
* Female of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods or male who is not using highly effective contraceptive method
* Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.
* Smallest diameter of treated or untreated nodular or linear leptomeningeal metastasis \>0.5 cm on MRI (Part 2 only)
Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis

Eligibility Criteria:
Inclusion Criteria:

* Participants legally competent to sign and give informed consented and if appropriate assent as required by local laws
* Males and females ages 2 years and older (inclusive)
* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
* Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
* In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
* Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

* Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.

  * Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  * Previous treatment with ARQ-151 or its active ingredient
  * Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
  * Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product
  * Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation
Dexmedetomidine on Segmental EEG Power Spectra

To compare the EEG power spectra activity during propofol-based anesthesia in the presence or absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia status.

Three groups of patients undergoing hysteroscopic examination and surgery will be studied: 1) control group, patients will receive propofol intravenous infusion to provide anesthesia; 2) dexmedetomidine 0.5 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia; and 3) dexmedetomidine 1 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia.

Each group will have 20 patients.

General conditions including blood pressure, respiration, and heart rates will be recorded.

EEG power spectra activity will be recorded no-invasively by a Narcotrend EEG monitor.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical status I to II grade.
* body mass index 18 to 25 kg/m2
* no vision or hearing impairment
* will receive general anesthesia

Exclusion Criteria:

* with psychological or mental diseases
* with neurological diseases
* treating with steroids or with alcohol dependence.
PKC as Serum Biomarkers for Depression

Inflammation that is mediated by microglia activation plays an important role in the pathogenesis of depression. Microglia activation can lead to an increase in the levels of proinflammatory cytokines, including TNF-α, which leads to neuronal apoptosis in the specific neural circuits of some brain regions, abnormal cognition, and treatment-resistant depression (TRD). Protein kinase C (PKC) is a key regulator of the microglia activation process. The investigators assume that the abnormality in PKC might be the serum biomarkers of depression.

PKC activation might reduce M1 microglia activation and the release of proinflammatory cytokines such as TNF-α, finally alleviating depressive symptoms in TRD.

Primary objective: This study was designed to address the role of PKC-mediated microglial activation in the clinical outcome of first episode depression.

Secondary objective: To illustrate the impact of PKC-mediated microglial activation on impaired cognition, social function and neuronal plasticity.

The investigators adopted randomized design to test placebo-controlled antidepressant augmentation. Patients were randomized (1:1) into one of the following 2groups: "SSRI +golimumab"," or "SSRI +placebo". The total study duration is 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);

  * Insufficient response (response rate \<50%) to two antidepressants with different mechanisms when given for at least 6 weeks at an adequate dose (e.g., clomipramine ≥150 mg/d, fluoxetine≥20 mg/d) during the current episode;

    * A 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 no more than 7 days prior to randomization. Cognitive factors (including a sense of guilt, suicidal thoughts, agitation, depersonalization, the disintegration of reality, paranoid symptoms, and obsessive and compulsive symptoms) score ≥6; ④ Between 18 and 65 years of age;

      ⑤ Education: finished junior middle school;

      ⑥ Ethnicity: Han Chinese;
      * Adequate audio and visual levels to complete the necessary checks; ⑧ Compliance with treatment in the clinical trial.

Exclusion Criteria:

* Severe liver and kidney diseases, active endocrine diseases or clinical symptoms. Severe cardiovascular disease, respiratory system disease, hematologic diseases and cancer.

  * Serious suicide attempts.

    * Pregnancy or lactation.

      * Modified electroconvulsive therapy (MECT) therapy in the past 1 month. ⑤ Known current psychosis as determined by the DSM-5 or a history of a non-mood psychotic disorder.

        * Participation in another clinical trial concurrently or no more than 1 month prior to randomization.

          * Previously had a severe allergic reaction or immune system disease; ⑧ Using an anti-inflammatory drug or immunosuppressive agent; ⑨ HAMD-17 item 3 (suicide) score: ≥3
Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.

Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics in cesarean section on post operative pain relief. In the study group before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration. Our hypothesis is that subcutaneous infiltration of the surgical wound by BUPIVACAINE + ADRENALIN at the end of cesarean section will reduce the intensity of post operative pain.

Cesarean section is one of the most common procedures in the world. There is an advantage in preventing pain after cesarean section, as opposed to treating pain that has already started. The infiltration of surgical wounds by local anesthetics is accepted as an effective method for preventing pain after various operations. In this study women who are admitted for a cesarean section will be randomly allocated into 2 groups. In the study group after the closure of the fascia above the rectus muscles, and before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration.

Eligibility Criteria:
Inclusion Criteria:

* cesarean section with regional anesthesia
* singleton
* pfannenstiel incision

Exclusion Criteria:

* cesarean section with general anesthesia
* maternal liver or kidney disease
* allergy to Bupivacaine
* allergy to Adrenalin
* intrauterine fetal death
* major fetal malformations
FreeStyle Libre Glucose Monitoring System Paediatric Study

The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥4 years and ≤17 years.
* Has an identified Caregiver of ≥18 years.
* Type 1 diabetes using insulin (administered by injections or CSII) for at least 1 year.
* Current insulin regimen has been unchanged for at least 2 months prior to enrolment (e.g. change of insulin or administration method), with no plans to change insulin regimen.
* Currently testing BG, on average at least 2 times per day.

Exclusion Criteria:

* Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition.
* Currently prescribed oral steroid therapy for any acute or chronic condition (or requires it during the study).
* Currently receiving dialysis treatment or planning to receive dialysis during the study.
* Female participant known to be pregnant.
* Participating in another device or drug study that could affect glucose measurements or glucose management.
* Currently using or planning to use FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device during the study.
* Has used the FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device in the previous 3 months.
* Known (or suspected) allergy to medical grade adhesives.
* In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason (participant and caregiver considered).
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer.

CreaVax-PC consisted of antigen (PSA, PAP and KLH) primed dendritic cell is an investigational product designed to activate a man's immune response, so they can detect prostate cancer cells and initiate an immune response against prostate cancer antigens.

If patients decide to participate and are eligible, they will be enrolled in the study and will receive active product (CreaVax-PC). In detail, patients will receive CreaVax-PC injection at intervals of 3 weeks, maximum 6 times during 21 weeks. PSA increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables. We also evaluate time to progression, overall survival and immune response.

Eligibility Criteria:
Inclusion Criteria:

* 1) Histological confirmed prostatic carcinoma patient
* 2) Hormone non-respondence ex1) Although treatment PSA ≥ 5ng/ml ex2) PSA level were measured two times ex3) Prior one year radiology were processed
* 3) Just 18 years over
* 4) Has a score ≤1 on the ECOG Performance Scale
* 5) Expected survival life time ≥ 6month
* 6) Adequate bone marrow function hemoglobin ≥ 10.0g/dL , leukocyte count ≥ 4,000/mm3 thrombocyte ≥ 100,000/mm3
* 7) Adequate blood coagulation function PT(INR) \< 1.5, aPTT\< 1.5 x control
* 8) Adequate kidney function Normal blood upper level Creatinine ≤ 1.5 times
* 9) Adequate liver function Normal blood upper level AST/ALT ≤ 1.5 times
* 10) Autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity
* 11) Person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy
* 12) Patient who voluntarily participated clinical trial and confirmed a written consent

Exclusion Criteria:

* 1) Having other malignancy or previous history of malignancy
* 2) Brain metastases patient
* 3) Having autoimmune disease or its history
* 4) Pyrexia, rigor, leukocytosis infectious disease
* 5) HBsAg, anti-HCV, HIV positive patient
* 6) Myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension
* 7) Severe and active medical disease
* 8) Mental history disease or epilepsy
* 9) Patients participated other clinical trial within 4 weeks
* 10) Patients impossible to participate this trial by investigator's decision
* 11) Patients who received immunosuppressant such as steroid, cyclosporin A, azathioprine within 6 weeks
Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study

The subjects of this study were patients with essential refractory hypertension. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.

The subjects of this study were patients with essential refractory hypertension. The study design was a single-center, open-label, self-controlled, single-arm, prospective study. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, no gender restrictions;
* Primary refractory hypertension: Taking three antihypertensive drugs, including a - diuretic, with an average office systolic blood pressure ≥150 mmHg measured three times;
* Duration of hypertension greater than 6 months;
* Standing plasma aldosterone and renin activity not below the lower limit of the unit's reference range;
* Signed informed consent form.

Exclusion Criteria:

* Morning cortisol level \< 4.3 µg/dL; estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m²; serum potassium level \> 5.5 mmol/L;
* Type 1 diabetes, uncontrolled hyperthyroidism, malignant arrhythmias, malignant tumors, decompensated heart failure, severe liver dysfunction, severe hematological diseases, severe obstructive sleep apnea syndrome, history of myocardial infarction, syncope, cerebral hemorrhage, or cerebral infarction within the past 3 months;
* Pregnant women or those planning to conceive within the next year;
* Presence of other severe organic diseases that would make the patient unable to tolerate superselective adrenal arterial embolization;
* Adrenal mass with a diameter exceeding 2 cm;
* Severe allergy to contrast agents;
* Patients enrolled or planning to participate in other clinical studies that could impact the results of this study.
Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

The main hypotheses for this study are as follows:

1. The use of NeuFlex implant results in flexion in the fourth and fifth MP joints that is at least 10 degrees greater than with teh use of the Swanson implant.
2. The use of the NeuFlex implant is associated with a significantly (2.5 kg or more) greater grip strength than with the use of the Swanson implant.

Many studies have evaluated metacarpophalangeal joint (MP) range of motion following Swanson arthroplasty. These studies report that overall MP flexion is restricted postoperatively. They do not usually report individual range of motion values for each digit. Therefore one cannot identify if the degree of MP flexion restriction differs by digit.

We, and others, have observed that MP flexion is particularly restricted in the ring and litter finger following Swanson arthroplasty.

There is a new implant (NeuFlex), which instead of being introduced in full extension, like the Swanson implant, has a resting position of 30 degrees of flexion. As MP flexion is particularly restricted in the ring and little finger, an implant that by design encourages flexion may be helpful. A need exists to establish if the use of the NeuFlex implant produces greater MP flexion in the ring and little finger where restricted flexion has been identified as a problem.

Eligibility Criteria:
Inclusion Criteria:

* rheumatoid arthritis
* primary metacarpophalangeal arthroplasty of all 4 digits

Exclusion Criteria:

* diagnosis of other connective tissue disorder (e.g. SLE, MCTD)
* previous surgery of MP joints
* revision metacarpophalangeal arthroplasty