cyrilzakka/clinical-trials huggingface dataset:
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"

The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult woman
* Negative pregnancy test at subject screening and randomization
* Aged 18-50 years (inclusive) at the time of signing the ICF
* Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, gynecological examination, clinical laboratory, ECG, echocardiography and vital signs
* BMI from 18.0 to 30.0 kg/m², inclusive, at time of screening visit
* Able to fulfil the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent

Exclusion Criteria:

* Known hypersensitivity to any of the investigational product ingredients
* Smoking if \> 35 years old
* Dyslipoproteinemia or use of antilipidemic agent
* Known diabetes mellitus
* Current use of antidiabetic drugs, including insulin
* Arterial hypertension
* Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.
* Any condition associated with abnormal uterine/vaginal bleeding.
* Presence of an undiagnosed breast mass
* Current symptomatic gallbladder disease
* History of pregnancy- or COC-related cholestasis
* Presence or history of severe hepatic disease
* Presence or history of pancreatitis if associated with hypertriglyceridemia
* Porphyria
* Presence or history of benign liver tumors (focal nodular hyperplasia and hepatocellular adenoma)
* Presence of renal impairment (glomerular filtration rate \[GFR\] \<60 mL/min/1.73m²)
* Hyperkalemia or presence of conditions that predispose to hyperkalemia
* Presence or history of hormone-related malignancy
* History of non-hormone-related malignancy within 5 years before screening; subjects with a non-melanoma skin cancer are allowed in the study
* Use of drugs potentially triggering interactions with COCs
* History of alcohol or drug abuse within 12 months prior to screening
* Presence or history of thyroid disorders
* Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last 3 months (90 days) prior to randomization. Subjects who participated in an oral contraceptive clinical study using Food and Drug Administration (FDA)/European Union (EU) approved active ingredients, may be randomized 2 months (60 days) after completing the preceding study
* Sponsor, contract research organization (CRO) or Principal Investigator's (PI's) site personnel directly affiliated with this study
* Is judged by the PI to be unsuitable for any reason
Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway

The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate oropharyngeal seal pressure in different head and neck positions and perform similarly during pressure controlled ventilation in neutral position, despite differences in their structural design.

Laryngeal Tube Suction Disposable, LTS-D (VBM Medizintechnik GmbH , Sulz, Germany) and Supreme Laryngeal Mask Airway, SLMA (Intavent Orthofix, Maidenhead, UK) are second generation, single-use, supraglottic airway devices( SADs), with added gastric access, for use in spontaneously and mechanically ventilated patients undergoing general anesthesia.

The effectiveness of the LTS-D and the SLMA has been well established; however, the oropharyngeal seal pressure of both devices in different head/neck positions and the performance of these devices using positive pressure ventilation have not been evaluated. Changing the head/neck position can alter the sealing capabilities of the SAD.

To the investigators best knowledge there are no studies comparing the oropharyngeal seal pressure in different head and neck position when using these devices.

Eligibility Criteria:
Inclusion Criteria:

* Patients ASA I and II with normal airways, for minor elective surgical

Exclusion Criteria:

* Age \<18 yr, weight \<50 kg, or \> 100 kg , a known difficult airway, active gastro esophageal reflux disease
A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in combination with Donafenib or Bevacizumab in patients with advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age.
* Fully understand the study and voluntarily sign the informed consent form.
* Histologically or cytologically confirmed diagnosis of metastatic or unresectable hepatocellular carcinoma (HCC).
* Life expectancy \>= 3 months.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

* Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
* Patients were deemed unsuitable for participating in the studyl by the investigator for any reasons.
Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.
* Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
* Measurable disease.

Exclusion Criteria:

* Subjects who are candidates for other potentially curative therapies.
* Subjects must not have received previous radioimmunotherapy.
* Subjects who have undergone a prior bone marrow transplantation within the last 6 months.
Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases

Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of metastatic liver cancer via histological examination or a characteristic imaging profile on dynamic computed tomography (CT) scan or magnetic resonance imaging (MRI) without indications for surgical resection
* Eastern cooperative oncology group performance status (ECOGPS) of 0 or 1
* Liver function categorized as Child-Pugh class A or B
* Stable non-hepatic metastases, such as skeletal, pulmonary, or lymph node metastases
* Hepatic tumor burden below 70%
* Expected survival duration exceeding six months
* Laboratory findings meeting specific criteria, including platelet count \>50×109 /L, hemoglobin \>8.0 g/dL, ANC count ≥1.5 × 109/L, bilirubin \<51 mmol/L, alanine and aspartate aminotransferase \<3 times the upper limit of the normal range, and serum creatinine \<1.5 times the upper limit of the normal range.

Exclusion Criteria:

* Active infection
* Presence of severe comorbidities, such as hepatic encephalopathy, refractory ascites, and esophageal variceal bleeding
* Prior liver resection
* Previous TACE therapy received at other healthcare facilities
* Poor performance status (ECOGPS \> 1)
Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B

The puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with haemophilia. The study will be conducted in the Nordic countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia population in the register part of the study.


Eligibility Criteria:
Inclusion Criteria:

* Part A population will be defined by having:
* at least one health care contact with main diagnosis haemophilia A or haemophilia B, and/or;
* at least one prescription of factor VIII or factor IX concentrates, or;
* bypassing agents used in the treatment of PwH during the inclusion period.
* Part B1 population: Relevant physician at each HTC with direct and frequent patient contact.
* Part B2 population: PwH 5 years or older listed at participating HTCs

Exclusion Criteria:

* NA
Protein Timing, Lean Mass, Strength and Functional Capacity Gains in Postmenopausal Women

This study evaluated the effect of protein intake immediately after resistance exercise on lean mass, strength, and functional capacity gains in postmenopausal women. Participants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance training protocol in the morning.

Both groups performed the same training protocol, differing only the time of protein or carbohydrate supplementation. The dietary assessment was made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. Resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. One maximum repetition (1-RM), handgrip strength and 1-mile walk were performed.

Eligibility Criteria:
Inclusion Criteria:

* Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);
* Healthy;
* Who agree to participate and sign the consent term.

Exclusion Criteria:

* The one who does not provide the necessary information for the development of the study;
* Present orthopedic limitations;
* Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.
The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency

Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy.

Premature ovarian insufficiency (POI) or premature ovarian failure (POF), is the loss of function of the ovaries before age 40, which has the features of menstrual disorder with high gonadotropic hormone and low estrogen. The morbidity of POI is about 0.1% among woman before 40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary amenorrhea. Recent years research shows different sources of stem cell could be used to POI, and with effective results.

Above all, this experiment designed to as a single center, random, and control experiment. treat POI patients wit human umbilical cord mesenchymal stem cells (MSCs). After regular follow-up and analysis, assessing the safety and effective of MSCs in POI treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria of European Society of Human Reproduction and Embryology
* No hormonotherapy and chinese traditional medicine within 3 months;
* Understand and sign informed consent.

Exclusion Criteria:

* Patient with congenital adrenocortical hyperplasia;
* Patient with Cushing syndrome;
* Patient with Thyroid dysfunction;
* Patient with hyperprolactinemia;
* Patient with pituitary amenorrhea or hypothalamic amenorrhea;
* Patient with HIV, hepatitis;
* Gene defect (eg. Turner syndrome, fragile X syndrome)
* Serious drug allergy history;
* Suffering from thrombophlebitis, thromboembolism including venous thrombosis and arterial thrombosis;
* History of treatment of ovarian cysts or ovarian surgery
* With high tumor marker;
* Pregnant or lactating
* Receive other treatments that may affect the efficacy and safety of stem cells;
* Do not understand or without sign informed consent;
* The attending physician believes that it is not suitable for participating in this trial
The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients

Stroke is the most common cause of motor function impairment. However, the functional impairment is not totally irreversible. Several mechanisms may involved in both the cortical and motor function recovery after onset of stroke, and most of them are related to changes of cortical perfusion and metabolism.

Motor function recovery after stroke (especially middle cerebral artery territory lesion) frequently follow stereotypic pattern (brunnström stage).

This study is designed to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage after stroke.

Participants receive evaluations (1/week for 3 months period) of

* motor function (Include: MMSE, brunnström stage, Fugl-Meyer Assessment of Physical Performance, Box and Block Test of Manual Dexterity, Functional Independence Measure)
* cortical perfusion detection during performing limb movements (using NIRS)

Then use path analysis to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke(unilateral, onset within 7 days, without previous stroke history)
* Vital sign stable
* Upper extremity motor function impairment(brunnström stage I\~III)

Exclusion Criteria:

* with pacemakers
* Seizure history
* Serious dysrhythmias
* Poor cognition function(MMSE\<13)
Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis

Radiation synovectomy by intra-articular injection of beta-emitting radionuclides is considered a reliable and easy-to-perform therapy without harmful side-effects for the treatment of inflammatory joint disease in many countries.

The goal of this study is to demonstrate Yttrium-90 citrate colloid or Rhenium-186 sulfide synovectomy are appropriate therapeutic interventions in patients with persistent active synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to systemic therapy and intra-articular corticosteroid injections.

The primary objective will be to assess the safety of an intra-articular administration of Yttrium-90 citrate colloid or Rhenium-186 sulfide.

The secondary objective will be to assess the efficacy on synovitis.


Eligibility Criteria:
Inclusion Criteria:

* There is no age limit for RSO
* Patient referred by a medical joint specialist (orthopedist, rheumatologist or internal medicine in the absence of local joint specialist)
* Patient having a refractory inflammatory articular disease:
* Failure of medical therapy after 6 months
* Clinical signs of an active mono or oligo synovitis
* Joint X-ray, echo or MR showing minimal cartilage or bone destruction
* Pain limits normal activities or requires significant analgesic medication

Exclusion Criteria:

* Prior RSO within last 3 months in that joint
* Collapse of the articular plateau or intra-articular fracture
* Surgery or arthroscopy within last 6 weeks
* Painful prosthesis
* Joint infection, local skin infection, bacteremia
* Joint puncture within last 2 weeks (increased risk of soft tissue necrosis along the needle track)
* Pregnancy or breast feeding
* Synovial cyst rupture
* Massive hemarthrosis
* Generalized synovitis defined as more than 5 uncontrolled joints by clinical examination or 3 phases bone scan
* Surgical synovectomy within 6months
* Cancer with bone metastases
* Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent
* Participation in any other ongoing clinical trial for the underlying inflammatory condition
Dextromethorphan for Treatment of Postoperative Pain

A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan compared to Placebo for the Treatment of Postoperative Pain

There is extensive preclinical evidence that dextromethorphan has an analgesic effect in patients with pain of traumatic origin. The primary objective is to of this study is to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing total knee arthroplasty (TKA).

This is a single-institution, multi-dose, randomized, placebo-controlled, trial to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing TKA. Male and/or female patients will be randomized to either dextromethorphan treatment group (n = 80) or placebo group (n= 80).

Patients will receive 60 mg oral dextromethorphan (or matching placebo) preoperatively, as well as 30 mg 8- and 16-hours postoperatively.

Eligibility Criteria:
Main Inclusion Criteria:

* Patients Age ≥18 planning to undergo total knee arthroplasty
* ASA classes I - III

Main Exclusion Criteria:

* BMI ≥ 35
* History opioid abuse
* History of intractable vomiting after previous surgery
Parents' and Clinicians' Perspectives of the Quick Parenting Assessment (QPA)

A quality improvement (QI) study that integrates an adverse childhood experiences (ACEs) instrument, including the Quick Parenting Assessment (QPA), into pediatric primary care visit.

Adverse childhood experiences (ACEs) are social determinants of health. ACEs include exposure to unhealthy parenting and family dysfunction. It is known that people who are exposed to adverse childhood experiences (ACEs) are at increased risk of over 40 health problems; some of these include heart disease, lung disease, obesity, smoking, alcoholism, illicit drug use, depression, suicide, and violence. The American Academy of Pediatrics recommends that primary care providers screen for and address ACEs/social determinants of health as part of the routine primary care visit.

Efforts are needed to develop and test algorithms that assess for ACEs in pediatric primary care and intervene as indicated.

The investigators have tested an ACEs screening instrument that includes the Quick Parenting Assessment with hundreds of parents of 2-10 year old children in the pediatric primary care clinic at Vanderbilt without incident (please see IRB# 161987).

The next step is a quality improvement (QI) study that integrates an ACEs screening algorithm into pediatric primary care visit.

In this study, the investigators integrate the Quick Parenting Assessment into the pediatric primary care visit at the 15 month, 30 month, 5 year, and 8 year visit. Key measures include parents' and health care providers' perspectives on the new service.

Eligibility Criteria:
Inclusion Criteria:

* Parents of 1-10 year old children presenting to a pediatric clinic for a well child visit.

Exclusion Criteria: Parents who do not speak English, Spanish, or Arabic.
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection

Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.


Eligibility Criteria:
Inclusion Criteria:

* The subject has been diagnosed with at least one solid primary or metastatic tumor greater than 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, breast and H\&N cancers.
* The subject has received clinical routine imaging diagnostic work-up within 8 weeks prior to the first \[18F\]AH111585 PET scan.
* The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care.

Exclusion Criteria:

* The subject has known hyper- or hypo-coagulation syndromes.
* The subject has received chemotherapy within 3 weeks, or received radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to the first \[18F\]AH111585 PET scan.
* The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer between the first and second \[18F\]AH111585 PET scans.
* The subject is scheduled to undergo biopsy for the target tumour between the first and second \[18F\]AH111585 PET scans.
* The subject has intra-hepatic tumour(s) only.
* For the immuno-histochemistry group, the subject's target tumour has been biopsied less than or equal to 1 week prior to the first \[18F\]AH111585 PET scan.