cyrilzakka/clinical-trials huggingface dataset:
Comparison of Cardiorespiratory Fitness Among Regular Exercisers With and Without Parkinson Disease and Across Different Modes of Group Exercise

The central goal of the proposed study is to generate essential pilot data necessary to support an established line of research leading to future extramural grant submissions. The aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and gait endurance across three groups of people: (1) individuals with Parkinson Disease (PD) who participate in boxing on a regular basis, (2) individuals with PD who participate in exercise other than boxing on a regular basis and (3) healthy controls of the same age who exercise on a regular basis and 2) to examine the relationship between CRF and motor symptoms of PD (bradykinesia, tremor and postural instability). Forty-five participants (15 for each group) who participate in exercise on a regular basis (at least 120 minutes of exercise per week for the past 3 months) will be recruited for this cross-sectional study. In a single testing session, participants will perform the following tests: (1) clinical performance measures and (2) a CRF assessment. A one-way ANOVA with appropriate post hoc tests will be used to examine differences in dependent variables across the three exercise groups. Relationships between CRF and clinical performance measures will be evaluated with Pearson's correlation coefficients.


Eligibility Criteria:
Inclusion Criteria:

* All participants included in this study must be between the ages of 55 and 75
* Be able to ambulate independently without physical assistance, assistive device, or lower extremity orthosis
* Be able to follow at least 3-step verbal commands
* Participate in a community-based group exercise program
* Be classified as regular exercisers by participating in 120 minutes per week for at least 3 months
* And have a physician's consent to undergo a graded exercise test (GXT).
* Furthermore, only participants that are identified as low or moderate risk for cardiovascular disease based on ACSM's risk stratification guidelines will be included in the study.
* Participants for the two PD groups must have a diagnosis of idiopathic PD
* Have a Hoehn-Yahr score of 1, 2, or 3
* And either participate regularly in boxing training at Rock Steady Boxing or participate in another community-based group exercise program on a regular basis, classified as 120 minutes per week for at least 3 months.

Exclusion Criteria:

* Participants may not be included in the study if they have had any surgery in the past 6 months
* Current musculoskeletal or complications from other health issues that influence walking.
* The participants without disability cannot be involved in the study if they have any preexisting neurological conditions.
* Participants with PD cannot be involved in the study if they have preexisting neurological conditions other than idiopathic PD (e.g. no diagnosis of Parkinson Plus syndrome), past brain surgery or implantation of a deep brain stimulator.
Comparison Between Volatile Anesthetic-desflurane and Total Intravenous Anesthesia With Propofol and Remifentanil on Early Recovery Quality and Long Term Prognosis of Patients Undergoing Pancreatic Cancer and Common Bile Duct Cancer Surgery

Investigators asses whether there is any difference in short term recovery and long term prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and bile duct cancer and undergoing surgery for PPPD or distal pancreatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA class I-III who are scheduled to undergo general anesthesia and who are diagnosed with pancreatic cancer or common bile duct cancer and who are scheduled for PPPD or distal pancreatectomy
* patients who voluntarily agree to participate the clinical study after fully informed and understood about the study

Exclusion Criteria:

* there was distant metastasis at the time of diagnosis
* history of drug adverse reaction or use of opioid or sedative drugs before the surgery
* patients who can not communicate enough to answer the survey
* obesity patients over BMI 30
* patient who are expected to maintain ventilator care on the first day of post operation due to the difficult to extubation right after the surgery
* patients who have inappropriate reasons to participate in clinical research
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease

This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.

Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.

This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.

After randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.

At week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.

At week 3 \&amp; 7, a phone consultation will assess safety.

Eligibility Criteria:
Inclusion Criteria:

* - Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan
* Informed consent as documented by signature

Exclusion Criteria:

* - renal replacement therapy or kidney allograft recipient
* chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)
* patients younger 18 years of age
* Diabetes mellitus type 1
* recurrent urinary tract infections (UTI) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year.
* Patients with uncontrolled hypertension (defined as ambulatory systolic BP over 180mmHg), liver cirrhosis (Child Pugh B and C)
* Patients not able or not willing to stop the following medications during the study period of participation in the trial:
* Thiazide diuretics
* Carbonic anhydrase inhibitors
* Sodium bicarbonate
* 1, 25 (OH) vitamin D (calcitriol)
* Bisphosphonate, denosumab, teriparatide
* Pregnant or lactating women
* Known allergy to study drug
* Inability to understand and follow the protocol
Measures for the Prevention of Surgical Site Infection

Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures.

Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures. Methods: It is a primary, randomized, analytical and single-center clinical trial, consisting of 170 patients, which were distributed between 2 randomized groups, where Chlorhexidine-based Soap + Alcoholic Chlorhexidine were tested on the group CSAC and Chlorhexidine-based Soap + 70% Ethyl Alcohol + Alcoholic Chlorhexidine were tested on the group CSAAC. Cultures were performed in the Mannitol and EMB (Eosin Methylene Blue) media after being collected at the pre, post-skin preparation and end of the surgical procedure

Eligibility Criteria:
Inclusion Criteria:

* patients both males and females; older than 18 years old who will undergo orthopaedic surgical procedures;

Exclusion Criteria:

* patients who do not follow the medical guidelines; that are non-collaborative and / or do not sign the terms of consent.
Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?

Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Reported wound-related local complications following mastectomy include seroma, flap necrosis, infection, hematoma, and nerve injury. Seroma causes discomfort and may delay the reconstructive procedures. Whether the removal or preservation of the pectoral fascia influences seroma formation following mastectomy remains unclear to our knowledge.

The primary objective of this pilot study is to investigate the impact of removal versus preservation of the pectoral fascia on drain policy and needle aspirations in women who undergo a bilateral prophylactic mastectomy. The secondary objective is to investigate the impact of removal versus preservation of the pectoral fascia on postoperative (surgical) complications.

The study design includes a double-blinded, prospective, randomized controlled pilot study with a within-subject design. All patients will undergo a bilateral prophylactic mastectomy and randomization will occur within the patient. Preservation of the PF will be performed in one breast (intervention), while removal of the PF will be performed in the contralateral breast of the same patient (control). Consequently, the operation involves a total bilateral prophylactic mastectomy, with unilateral preservation of the PF

The follow-up time of each patient will be 6 weeks. The patients' files will be viewed after the removal of the drain for additional recorded variables.

Eligibility Criteria:
Inclusion Criteria:

* Female patient
* Scheduled for a bilateral prophylactic mastectomy in the Erasmus MC Academic Breast Cancer Centre in Rotterdam
* Ability to give written consent
* Adequate understanding of Dutch language

Exclusion Criteria:

* History of diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
* Other malignancies
Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer

In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.

This study was a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 75 years; (2) Histologically confirmed right-sided colon adenocarcinoma；(3) Clinical stage I-III; (4) Performance status (ECOG) 0-1; (5) Adequate hematological, hepatic and renal function. Patients operated on as an emergency, or with tumours in the transverse colon, or with other previous malignancy within 5 years were excluded.

All particapants were recruited and randomly assigned to receive laproscopic or open right hemicoloectomy. All patients were treated with an ERAS protocol. The primary end-point was the incidence of postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification. The secondary end-points were ERAS adherence, readmissions, reoperations, hospital length of stay, mortality, and survivals. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma;
3. Together with clinical or radiological evidence of Stage(T1-2,N0, M0) Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)
4. Performance status (ECOG) 0\~1
5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
7. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
2. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
3. Known drug abuse/ alcohol abuse
4. Legal incapacity or limited legal capacity
5. Pre-existing peripheral neuropathy.
Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke

The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to determine the feasibility of including robotic therapy in daily rehabilitation programmes, after stroke. Additionally, we aim to investigate the acceptance of this intervention from patients and therapists. A total of 10 patients will be recruited in this study, all the patients will receive 1 hour of standard therapy together with 45 min of robot therapy every day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period of four weeks. Additional 15 minutes are required for placing surface electrodes on the shoulder and patient preparation. The study will include passive and active shoulder training of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from stroke, ischemic and / or hemorrhagic
* Stroke in the left hemisphere
* Score between 1 and 3 in the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale (IT-NIHSS) (Pezzella et al. 2009)
* Score of the Functional Independence Measure (FIM) scale (Keith et al., 1987) less than 100 out of a total of 126. This scale is used as a reference to indicate the degree of autonomy in carrying out activities of daily living (ADLs)
* Score of the upper-limb Fugl-Meyer scale (FMA) (Fugl-Meyer et al., 1975) less than 60. This scale measures the residual motor function of a person after stroke

Exclusion Criteria:

* Non-stabilized fractures
* Diagnosis of depression
* Traumatic brain Injury
* Pharmacologically uncontrolled epilepsy
* Ideomotor apraxia
* Neglect
* Mini Mental State Examination (MMSE) score \<20/30
* Severe impairment of verbal comprehension, defined by a score in the Token Test (Tau points\<58/78)
* Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery, etc)
Increasing Hepatitis B Screening Among Korean Church Attendees

The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Korean Americans.

The investigators will design a culturally specific intervention (educational sessions) and test the effect of the intervention on 1200 Korean Americans.

All subjects will be interviewed before the intervention/control sessions and 6 months after the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening will be verified by a review of subjects' medical records.

The primary study hypothesis is that the intervention group will have a higher rate of HBV serologic testing at follow-up compared to the control group.

The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Korean Americans.

The investigators will design a culturally specific intervention; an educational small group discussion led by a trained Korean leader. The effect of the intervention will be tested on 1200 Korean Americans.

Subjects will be recruited at Korean churches and invited to join a one-hour discussion of health issues with other members of their church. One half of the subjects will participate in the intervention group. These subjects will discuss HBV and will receive resources related to HBV and where to obtain screening. The other half of the subjects will participate in the control group. These subjects will discuss nutrition and physical activity and will receive resources related to these topics, but not related to HBV and where to obtain screening.

All subjects will be interviewed before the sessions and 6 months after the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening will be verified by a review of subjects' medical records.

The primary study hypothesis is that the intervention group will have a higher rate of HBV serologic testing at follow-up compared to the control group.

Secondary hypotheses are:

The intervention group will have a higher level of knowledge of hepatitis B and liver cancer at follow-up compared to the control group.

The effect of the intervention on hepatitis B serologic testing will be mediated by knowledge of hepatitis B and liver cancer.

Eligibility Criteria:
Inclusion Criteria:

* Korean ancestry
* Have not previously received HBV screening or do not know the results of previous HBV screening test
* No history of liver cancer or liver disease
* Current resident of the Los Angeles area

Exclusion Criteria:

* Younger than 18 years of age or Older than 64 years of age
* Not of Korean ancestry
* Previously screened for HBV
* History of liver disease or liver cancer
* Not a current resident of the Los Angeles area
RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients

The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus.

Background: Cosmos caudatus (C. caudatus) ethanol extract has been reported to have extraordinary high antioxidant capacity compared to other plants. Furthermore it has been shown to reduce the plasma blood glucose and lipid profile significantly in an animal model. However, no study has been reported on its effectiveness in human. Therefore, we plan to conduct a randomized controlled trial to evaluate the effectiveness and safety of C. caudatus on glycemic status, oxidative stress markers, inflammatory markers, lipid profile in patients with type 2 diabetes. Besides, metabolomics approach will be carried out to compare the metabolite changes between diabetic C. caudatus treated and control patients.

Methods: A single-center randomized, controlled, two-arm parallel design clinical trial will be carried out in Malaysia. This study enrol 92 patients diagnosed with type 2 diabetes. Diabetic patients who meet eligibility criteria will be randomly allocated to two groups, which are C. caudatus treatment group and control group. Both groups will be compared on the primary and secondary outcomes at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy.

Discussion: The study will provide insights into the potential beneficial effect of C. caudatus in type 2 diabetic patients. In addition, the therapeutic effect of C. caudatus towards type 2 diabetes will reflect as a change of metabolite profile in urine and serum.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed type 2 diabetes with at least 6 months diagnosis
2. BMI between 18.5-40 kg/ m2
3. Able to comply to the study protocol
4. They are treated with stabilized dose of oral diabetic agents

Exclusion Criteria:

1. Pregnant and lactating
2. Have any gastrointestinal disorder that interferes the bowel function, severe hepatic or renal disease (dialysis), an infection that requires antibiotics within three weeks
3. They are currently on insulin regimen.
4. Individuals on the following drugs which will possibly have herb-drug interaction: anticoagulant such as warfarin and aspirin, corticosteroids (Prednisolone), fluoroquinolones (ciprofloxacin, levofloxacin), doxorubicin, cisplatin, cyclosporine, and digoxin
Evaluation and Validation of Metabolic Markers for the Assessment of CYP3A Activity and Prediction of DDI

Evaluation and validation of metabolic markers for the assessment of CYP3A activity and prediction of drug-drug interaction in Korean healthy subjects.

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Urine collection is scheduled drug 12 hour before and 24 hour after midazolam administration. Subjects will be dosed study drug via intravenous around at 9 a.m. of Day 1. Subjects performed scheduled procedures.

In period 2, Subjects will be admitted on Day 3-5. Subjects performed scheduled period 2 (Itraconazole co-administration phase, 2 times administration of itraconazole 200 mg), and period 3 (rifampicin 150 mg co-administration phase) procedure. Study participation was terminated on post-study visit (Day 23\~35).

Eligibility Criteria:
Inclusion Criteria:

* Age: Between 20 to 40 years of age, inclusive
* Weight: within 17-28 of Body Mass Index (BMI)
* Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

* History of hypersensitive reaction to medication (midazolam, itraconazole, rifampicin)
* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
* History or evidence of drug abuse
* Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
* Participation in clinical trials of any drug within 60 days prior to the participation of the study
* Judged to be inappropriate for the study by the investigator