cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus

Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial hyperglycemia and improves overall glycemic control.

This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in patients with type 2 diabetes mellitus.

Group I (Mitiglinide): Mitiglinide 10 mg three times a day, orally, for 12 weeks Group II (Acarbose): Acarbose 50 mg three times a day, orally, for 12 weeks Total subjects: 248, randomized to 2 groups at ratio of 1:1.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 18 and 70, regardless of gender
2. Subjects with type-2 diabetes mellitus diagnosed according to 1999 WHO criteria within 5 years
3. Subjects who had not received insulin secretagogues, insulin sensitizers, incretin mimetics or alpha-glucosidase inhibitors
4. Subjects whose fasting blood glucose \[FBG\] between7.0 and10.0 mmol/L and HbA1c ratio is between 7.0% and 10.0%

Note: Incretin mimetics contain glucagon-like peptide 1 (GLP-1) receptor agonist (including GLP-1 analogues) and dipeptidyl peptidase 4 inhibitors.

Exclusion Criteria:

1. Subjects with abnormal hepatic function whose aspartate transaminase (AST) and alanine transaminase (ALT) are 2 times higher than the upper limits of normal (ULN)
2. Subjects with renal disfunction whose plasma creatinine concentration are more than 1.1 ULN or positive urine protein
3. Subjects with severe heart disease, liver diseases, kidney disease and other serious organic disease
4. Subjects who have chronic intestinal diseases associated with marked disorders of digestion or absorption and may deteriorate as a result of increased gas formation in the intestine (like Gastrocardiac Syndrome, severe hernia, intestinal obstruction, intestinal ulcer and intestinal surgery)
5. Subjects with endocrine system diseases such as hyperthyroidism and cushing's syndrome etc.
6. Subject is contraindicated or hypersensitivity to both experimental drugs or comparator drugs
7. Subjects who participated in other clinical studies as subjects within 3 months before this study
8. Female subjects who have been pregnant , lactating or without contraception in childbearing potential
9. Subjects judged unfit for this study by investigators
Clinical Trial of BT02 in Patients With Advanced Solid Tumors

A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors

Overall study design:

This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 at the time of signing the informed consent form, male or female;
2. Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
3. Adequate organ and hematologic function;
4. Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
5. ECOG performance status 0\~1;
6. Life expectancy ≥ 3 months;
7. Good compliance and be willing to follow-up visit.

Exclusion Criteria:

1. Receive treatment before study as below:

   a) Previous systematic anti-cancer therapy;
2. Active or prior documented autoimmune disease within past 2 years;
3. History of clinically significant cardiovascular disease;
4. Significant acute or chronic infections;
5. Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
6. Any prior Grade≥3 irAE while receiving immunotherapy;
7. Unstable brain metastasis or meningeal metastasis with clinical symptoms;
8. Patients with mental disorders or poor compliance;
9. Known alcohol or drug abuse;
10. Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.
Plexaa for Preconditioning: Gender Affirming Mastectomy

The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability.

Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).


Eligibility Criteria:
Inclusion Criteria:

* All transgender or non-binary patients over the age of 18 years (no maximum age limit)
* Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation

Exclusion Criteria:

* Patients undergoing surgery for breast cancer
* Delayed (two-stage) breast reconstruction patients
* Patients undergoing simple mastectomy or wide local excision of a breast tumour
* Presence of open breast skin wounds, or infected or inflamed breast skin
* Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device
Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection

This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).


Eligibility Criteria:
Key Inclusion Criteria:

* Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more than 120 days prior to Baseline (Day 1), except for participants from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol.
* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Must be willing and able to comply with the visit schedule and study requirements
* Must have documented HBV DNA \< 2,000 IU/mL at time of screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149
* Must have documented hepatitis B surface antigen (HBsAg) negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment

Key Exclusion Criteria:

* Patient participating or planning to participate in another clinical study with an investigational agent
* History of clinically-significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
* Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed
* Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Splenectomy During Whole Liver Transplantation

Indications for splenectomy during whole liver transplantation remain controversial and splenectomy is often avoided because of common complications. The objective is to evaluate specific complications of these combined procedures.

Data on patients who underwent splenectomy during liver transplantation were retrospectively analyzed . Participants underwent splenectomy as part of routine medical care. Patients undergoing simultaneous liver transplantation and splenectomy were matched to a non-splenectomy group.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing liver transplantation between 1994 and 2013

Exclusion Criteria:

* Data from living donor patients, split liver transplantation, patients with pre- or post-operative splenectomy in medical history, and patients under 16 years were excluded from analysis
Injeti Self-Esteem Model and University Students

The purpose of this study is to explore the effectiveness of the Injeti Self-Esteem Model (ISEM) with a psychoeducational therapy intervention for improving self-esteem among university students. To explore the effectiveness of the ISEM (see Appendix A), investigators are utilizing a mixed method study design to acquire both quantitative and qualitative data to view effectiveness through measurable outcomes and personal experience. The intervention will involve a 1-hour session, which will include administration of the ISEM.

To explore the effectiveness of the ISEM investigators are utilizing a mixed-method study design to acquire both quantitative and qualitative data to view effectiveness through measurable outcomes and personal experience. Quantitative data will be gathered through standardized assessments, questionnaires, and demographic information. Qualitative information will be gathered through two interviews.

Pre-intervention data collection will include a Demographic Questionnaire, Rosenberg Self-Esteem Scale (RSES), and the Adverse Childhood Experience Questionnaire (ACE). The intervention itself will involve a 50-minute session consisting of the administration of the ISEM. All researchers will be trained to administer the ISEM by the Principal Investigator. After the intervention, data collection will involve two semi-structured interviews (SSI 1 and 2) that each require a completion of the RSES.

Inclusion/Exclusion Criteria.

Participants will include up to 150 students from varying universities throughout the Inland Empire ranging from 18-35 years of age. Participants must currently be enrolled as full-time or part-time students in an undergraduate or graduate program. English fluency in all areas (reading, writing, speaking, comprehension) will be required from all participants.

Investigators will recruit from each of the eight schools at Loma Linda University who have provided a signed Letter of Agreement (see Appendix B) using digital flyers via email communication. We will also recruit via snowballing.

The instruments we will use to collect data will include a Demographic Questionnaire, the Rosenberg Self-Esteem scale, the Adverse Childhood Experiences Questionnaire for Adults, and semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 35
* Must currently be enrolled as full-time or part-time students in an undergraduate or graduate program.
* English fluency in all areas (reading, writing, speaking, comprehension)

Exclusion Criteria:

* \<18 or \>35 years of age
* Does not meet student status
* Not fluent in English
Virtual Reality Games in Pediatric Surgery

Randomized controlled trial reporting the pain levels and pain control/reduction of children at the age of 6-15 undergoing surgical procedures by using virtual reality gaming (VR) compared to nitrous oxide. Therefore, 50 patients in each treatment group are recruited, resulting in 100 children altogether. The pain levels and pain control/reduction is measured by the standard anesthesia protocol normally used when nitrous oxide is applied and questionnaires that are administered to the patients at baseline and two weeks after surgery including both the primary and secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Indication to undergo an elective minor surgical procedure (removal of percutaneous osteosynthesis or pin material or dressing change)
* Written informed consent by parents
* Written informed consent by patient if patient is 14 or 15 years old

Exclusion Criteria:

* Inability to understand the VR-program
* Inability to fill in the questionnaire because of language deficiencies
* Neurologic disorders
* Respiratory tract infections
* Intolerance of the VR headset or VR gaming procedure
Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia

The main objective of this observational survey is to estimate the incidence, the typology, and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old. In this age group (aged more than 60y), three groups of patients with very different response rates and late outcome can be delineated with specific standard chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or more
* With a morphologically proven diagnosis of AML according to WHO 2008 classification
* Not previously treated for AML
* Signed informed consent.

Exclusion Criteria:

* APL in the WHO classification.
* Ph1-positive AML or prior Ph1-positive disease
* AML evolving from a prior MPN in the WHO 2008 classification.
* Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
* ECOG Performance Status Score \> 3
* Positive serology for HIV or HTLV1, or active viralinfection for HBV and HBC.
* Severe uncontrolled infection at inclusion time.
* Psychiatric disease or an history of non-complianceto medical regimens or patients considered potentially unreliable.
* Absence of Health Care Insurance
Relationships Between Exercise and Appetite in Women with Loss of Control Eating

This pilot study is a first step in looking at the relationship between exercise and appetite in women with loss of control eating.


Eligibility Criteria:
Inclusion Criteria:

* Engage in loss of control eating at least 12 times in the last three months
* Clinically significant eating disorder-related impairment (CIA \&gt; 15)
* Taking hormonal contraception
* Minimum VO2max of 50th percentile for age and sex assigned at birth
* Be willing to eat study-provided foods
* Likes chocolate (at least 6/10 on 10 point scale)

Exclusion Criteria:

* BMI \&amp;lt; 18.5 kgm/2
* Medical conditions that affect appetite or weight (e.g., diabetes mellitus, thyroid disease)
* Recent pregnancy or breastfeeding (prior 6 months)
* Relevant food allergies (e.g., wheat, chocolate)
* Specific phobia, blood-injection-injury type
* Medical condition that precludes safe participation in exercise (e.g., stress fracture)
* Medications that acutely affect appetite (e.g., GLP-1 agonists; psychiatric medications allowed)
3DKnee™ System vs. the MJS Knee System

The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.

The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.

Eligibility Criteria:
Inclusion Criteria:

* This must be a primary knee replacement on this knee.
* Patient is over 18 years of age or older
* Patients must have one of the following

  * rheumatoid or traumatic arthritis OR
  * joint disease secondary to osteoarthritis
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant

Exclusion Criteria:

* Is younger than 18 years of age
* If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
* Overt infection
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity
* Marked bone loss
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant
The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation

Up to 174 patients undergoing renal transplantation will be randomized to one of two groups. Randomization will be based on computer-generated codes using random block sizes ranging from 4 to 8.

Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA

The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic benefit. In addition, the presence of any pain at the incision site will be noted at the 1 month surgical follow-up to determine any evidence of chronic pain.

The investigators hypothesis is that unilateral kidney transplant patients with a continuous TAP catheter will have decreased pain scores and opioid usage compared to those receiving standard analgesic therapy.


Eligibility Criteria:
Inclusion Criteria:

* The patient is \>18 years of age
* The patient has provided written informed consent and understands the explanation of the protocol.
* The patient is scheduled to have a unilateral renal transplant with a flank incision

Exclusion Criteria:

* Patients aged \<18.
* Patients with a known allergy to amide local anesthetics or para-aminobenzoic acid.
* Patients who are unable to understand the verbal analog pain scale.
* Patients who decline participation.
* Patients with a midline abdominal incision.
* Combined transplants, ie. Kidney-pancreas
6 Month Follow up Study on the Changes of Postural Stability in Parkinsonian Patients in Response to High Frequency TMS.

Postural instability is one of the cardinal signs in Parkinson's disease (PD). It represents one of the most disabling symptoms in the advanced stages of the disease. It is associated with frequent falls and loss of independence. The aim of the current study is to assess the long term efficacy of high frequency repetitive transcranial magnetic stimulation (rTMS) on improving postural instability in PD patients.

Thirty to forty PD patients will be recruited who fulfill the U.K Parkinson's Disease Brain Bank Criteria for idiopathic PD. Patients with mild to moderate disease severity according to UPRS and Modified Hoehn and Yahr staging, age ranged from 55-70 years, duration of illness from two to five years will be included. The patients who will match our inclusion criteria will be assigned randomly into two equal groups; control group (G1) will receive a designed physical therapy program and study group (G2) will receive 12 sessions of (5Hz) rTMS over the primary motor cortex in addition to the same physical therapy program as in G1. The treatment will be conducted three times per week, over four weeks.

Biodex balance system will be used to assess objectively balance indices (overall, anterio-posterior and medio-lateral balance index) and dynamic limit of stability (overall LOS score, time to complete test) pretreatment , posttreatment and one month later as a follow up.

Eligibility Criteria:
Inclusion Criteria:

* All included patients should fulfill the U.K Parkinson's Disease Brain Bank Criteria for idiopathic PD.
* Patients with mild to moderate disease severity according to UPRS and Modified Hoehn and Yahr staging
* Duration of illness from two to five years were included.
* All included patients should be medically and psychologically stable and of adequate cardiac function.
* All included patients should haven't receive any rTMS sessions before.
* Signed consent form should be taken from all included patients.

Exclusion Criteria:

* Patients with implanted devices, serious medical illness or history of seizures were excluded.
* Patients with severe freezing phenomenon or severe tremors were excluded
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Genotype 1, chronic hepatitis C
* Non-responders (patient who did not respond to previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Pharmacokinetic and Safety Study of Cenicriviroc and Pioglitazone, When Dosed Alone or in Combination

A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK of PGZ administered with and without CVC.

This is a open-label, fixed-sequence, 3-period study being conducted in a single center to evaluate the following:

* PK of CVC administered with and without PGZ
* PK of PGZ administered with and without CVC
* Safety of CVC administered with and without PGZ
* Tolerability of CVC administered with and without PGZ

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* BMI ≥ 18 and ≤ 35 kg/m2
* No clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations, and 12-lead ECG
* Agree to comply with the study procedures and restrictions

Exclusion Criteria:

* Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant conditions as determined by the investigator
* History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy
* Serum ALT, AST or bilirubin ≥ grade 1 (ALT and AST \> ULN - 3.0 x ULN; bilirubin \> ULN - 1.5 x ULN) at screening
* Positive for HIV, HBV or HCV infection
* Use of any prescription drugs or prohibited medications within 30 days from the first dose of the study medication
* Use of alcohol-containing or caffeine-containing foods or beverages within 72 hours prior to the first dose of study medication