cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function

The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with impaired hepatic function compared with normal hepatic function.

A Phase 1, Non-randomized, Open, Parallel-Group study.

Eligibility Criteria:
A. Inclusion Criteria

\[The subjects with impaired hepatic function\]

1. The subjects who are 19 to 64 years old
2. The subjects with stable hepatic disease and impaired hepatic function as Child-Pugh A or B
3. Body Weight ≥ 55kg
4. If females, Negative for pregnancy test at the screening and pre dose of Day 1
5. The subjects who agreed with performing contraception during the study
6. The subjects who agreed with written informed consent

\[The subjects with normal hepatic function\]

1. The subjects who are 19 to 64 years old
2. The subjects who are matched impaired hepatic function by gender, age(± 5years) and body weight(± 10kg)
3. If females, Negative for pregnancy test at the screening and pre dose of Day 1
4. The subjects who agreed with performing contraception during the study
5. The subjects who agreed with written informed consent

B. exclusion criteria

\[The subjects with impaired hepatic function\]

1. The subjects with impaired hepatic function as Child-Pugh C
2. The subjects had a portosystemic shunt surgery
3. The subjects had a liver transplantation or unsuitable for the study by the investigator's judgement(for examples, hepatic encephalopathy grade 3 or 4, stroke, heart failure, cancer etc.) but The subject is eligible to participate if had not chemotherapy or radiofrequency ablation therapy within 6months)
4. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
5. The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1
6. Positive for anti-HIV Ab or venereal disease research laboratory etc.

\[The subjects with normal hepatic function\]

1. The subjects with liver disease or abnormal Laboratory test(Asparate transaminase \>1.25 fold of upper normal limit, Alanine transaminase\>1.25 fold of upper normal limit, Total bilirubin \>1.5 fold of upper normal limit)
2. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
3. Estimated Glomerular filtration rate \< 60 mL/min/1.73m2 by Modification of Diet in Renal Disease formula
4. Positive for HBsAg, anti-Hepatitis C virus Ab, anti-HIV Ab or venereal disease research laboratory
5. The subjects with high blood pressure or low blood pressure(systolic blood pressure \>150mmHg or \<100mmHg, diastolic blood pressure\>90mmHg or \<60mmHg)
6. The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1 etc.
A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer

NORPACT-3 is a nationwide, Norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. Eligible patients are treated with primary chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up. The primary aim is a national resection rate of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy, with adequate overall survival and morbidity/mortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival \>20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (Clavien Dindo grade 3) ≤40%).


Eligibility Criteria:
Inclusion Criteria:

* Borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2021) (Appendix 3)
* Nx, M0 (UICC 8th version, 2016)
* Cytological or histological confirmation of adenocarcinoma
* Age \>18 year
* Considered able to receive primary chemotherapy and possible surgery
* Written informed consent

Exclusion Criteria:

* Co-morbidity or performance status precluding primary chemotherapy
* Co-morbidity or performance status precluding pancreatectomy
* Female patients in child-bearing age not using adequate contraception, pregnant or lactating women
* Mental or physical disorders that could interfere with treatment of with the provision of informed consent
* Any reason why, in the opinion of the investigator, the patient should not participate
DPBRN Peri-operative Pain and Root Canal Therapy

The purpose of this study is to identify pre-operative factors that put patients at greater risk of developing severe tooth pain following root canal therapy, thereby providing evidence that will allow dentists to act preventively to lessen this risk, improve pain control, increase their patients' quality of life, and decrease the number of dental emergency interactions.

A parallel goal of this study is to assess the feasibility of recruiting dentists that provide root canal therapy and patients using the DPBRN.

Goals for this study is to:

* Assess the frequency and intensity of pre-operative pain
* Evaluate the occurence and intensity of intra-operative pain
* Evaluate the occurence and intensity of post-operative pain
* Assess the interference of persistent tooth pain with daily life
* Identify a limited set of risk factors related to the development of post-operative pain.

Eligibility Criteria:
Inclusion Criteria:

* 19-70 years old
* permanent adult tooth requiring it first non-surgical root canal therapy
* patients with more than 1 tooth requiring root canal therapy are eligible, but only the first root canal procedure performed will be included to avoid problems of correlation within patients

Exclusion Criteria:

* Evidence of prior root canal therapy, including iatrogenic, but not disease-induced, pulp access of the tooth being considered
* patients with obvious cognitive impairments (e.g., past stroke with communication deficits, dementia, mental disability)
* patients unable to return for 6 month follow-up, since another study plans to obtain data of these patients at that time (DPBRN Persistent Tooth Pain)
Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS

This pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery. Peripheral nerve tissue contains Schwann cells which produce growth factors that have been demonstrated to support the survival and function of neurons.

Participants will serve as their own donor for the tissue, which will be implanted at the time they undergo DBS surgery.

The primary objective of this pilot study is to demonstrate safety of the approach: introducing a minor modification of a standard, FDA approved neurosurgical procedure in use for over a decade to implant autologous peripheral nerve into the central nervous system. As such, the study is designed to pose minimal risk and minimal inconvenience to the subjects. Additionally, the test paradigm is performed strategically to not interfere with the surgery or delivery of the scheduled clinical DBS therapy. The scientific basis for this study is that the implanted peripheral nerve tissue is naturally well suited to provide multiple growth factors that have been shown experimentally to support the survival and function of dopaminergic neurons. Central to this proposal is the hypothesis that the implanted tissue will physiologically deliver growth factors to restore to normal function the afflicted neurons found in PD.

The first specific aim is to assess the feasibility and safety of the combined peripheral nerve graft/DBS surgical procedure. The second specific aim is to evaluate the long term clinical safety of the peripheral nerve implant.

This pilot study will provide safety data that can be used to generate a larger phase III clinical trial. If successful, it would herald the development of a new treatment for PD in which patients are able to provide their own tissue as a source of growth factors that could arrest or reverse the ongoing cellular loss that is responsible for their devastating dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing DBS of the STN or GPi
* Between the ages of 40-75
* Able to give informed consent
* Show a positive response to Sinemet (carbidopa/levodopa)
* Be able to tolerate the surgical procedure

Exclusion Criteria:

* Any condition that would not make the subject a candidate for DBS of the STN or GPi
* Under the age of 40 or over the age of 75
* Unable to give informed consent
* Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
Testing the Feasibility and Preliminary Effect of Summer Camp

This pilot randomized controlled trial was designed to assess the feasibility and preliminary efficacy of randomizing children, ages 6-12 years from two low-income communities in Rhode Island, to attend a summer day camp (CAMP) or to experience summer as usual (SAU). Children randomized to CAMP attended a Boys and Girls Club summer day camp for 8-weeks in summer 2017 or 2018. As part of the consent process, children randomized to SAU agreed to experience an unstructured summer (i.e. not enroll in more than one week of summer camp, summer school or other structured summer programming). Primary feasibility outcomes included retention, engagement and completion of midsummer measures. Secondary outcomes, change in BMIz (a proxy for excess summer weight gain), physical activity engagement, sedentary behavior, and diet (energy intake and diet quality), were collected by blinded research staff at the end of the school year, midsummer and the end of the summer.


Eligibility Criteria:
Inclusion Criteria:

* Qualify for free or reduced-price meals at school
* Speak English (for purposes of camp participation)
* Agree, along with their parent(s), to randomization.

Exclusion Criteria:

* A medical condition that interferes with participation in physical activity
* Enrollment in summer programming (camp, summer school, etc) for more than one week
Impact of Rehabilitation in Quality of Life in PD

This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative program on quality of life in patients with Parkinson's Disease.

Parkinson's Disease (PD) is a progressive neurodegenerative disease clinically characterized by rigidity, bradykinesia and resting tremor. Beyond these symptoms the principal feature of this condition is the lost of habitual automatic movements and the disruption of different cognitive-motivational processes. These features are related to a pathological dopaminergic tone that alters the cortico-striatal pathways with several consequences on motor and emotional behaviours. Given its complexity PD impact very seriously on patients' quality of life (QoL).

Dopamine replacement therapy (DRT) is the standard treatment for the motor symptom of PD and previous studies have demonstrated its positive effect on QoL. However DRT does not reduce axial PD symptoms such as freezing of gait, postural instability and balance disturbances. Further, long-term DRT could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects.

In the last years, rehabilitation has been proposed as an effective and complementary treatment for the management of PD and several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results.

To evaluate the impact of an intensive, multidisciplinary rehabilitation treatment (MIRT), on QoL of subjects with PD. Literature data showed that this type of treatment determine a positive effect on both motor and non-motor symptoms. Starting from these evidences, in this study the investigators have examined whether MIRT act positively on QoL and for how long this potential positive effect is maintained.

250 PD patients with Parkinson's Disease hospitalized for a 4-weeks MIRT were enrolled. PDQ39 was administered at enrolment, and at three points after discharge: at 1, 3 and 6 months. The investigators decided to evaluate QoL after homecoming in order to avoid an inpatient state bias. Other outcome measures were considered and assessed at the enrolment and at discharge: Unified Parkinson's Disease Scale (UPDRS), Parkinson Disease Disability Scale (PDDS), Berg Balance Scale (BBS), FOG (Freezing of Gait Questionnaire), 6MWT (6 minutes walking Test), Time Up and Go test (TUG). Cognitive and psychopathological status of patients was also assessed using Mini Mental State Examination (MMSE), Frontal Assessment Battery (FAB), State Trait Anxiety Inventory (STAY I-II), Beck Depression Inventory (BDI).

Eligibility Criteria:
Inclusion Criteria:

* Parkinson Disease
* MMSE ≥ 24

Exclusion Criteria:

* Co-morbidity with other neurological disease
* Visual and auditory dysfunctions
Master Study Investigating the Guiding Catheter Selectra 3D

Study investigating the guiding catheter Selectra 3D

The guiding catheter 'Selectra 3D' is a catheter that is intended to support the implantation of a pacemaker lead in untypical positions in the heart like in the His- bundle area.

This study is designed as post market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the guiding catheter Selectra 3D that remained unrevealed even after risk analysis, risk mitigation and successful conformity assessment. Moreover, the study aims at providing additional PMCF data, as required by regulatory authorities. Furthermore, the performance and efficacy of the Selectra 3D shall be assessed. The results will be used for updating the clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Standard indication for de novo pacemaker or cardiac resynchronization implantation
* The patient is intended for guiding catheter based implantation of a pacemaker system
* Patient is able to understand the nature of the study and has provided written informed consent
* Patient is willing and able to perform all follow up visits at the study site
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring® concept

Exclusion Criteria:

* AV block with no escape rhythm or broad QRS escape rhythm
* Standard contraindications for use of the investigational devices:
* Existing or possible occlusion of the coronary vessels or unsuitable anatomy of the coronary veins
* Active systemic infection
* Mechanical tricuspid valve prosthesis or severe tricuspid valve diseases
* Intolerance against dexamethasone acetate
* Planned cardiac surgical procedures or interventional measures in addition to the study procedure within the next 6 months
* Expected to receive heart transplantation or ventricular assist device within 1 year
* Patient is pregnant or breast feeding
* Less than 18 years old
* Participating in another interventional clinical investigation
* Life-expectancy is less than 1 year
Effect of Duration of Exposure of Anesthesia With Sevoflurane on Emergence Delirium

Emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with Sevoflurane. Restless recovery from anesthesia may not only cause injury to the child or to the surgical site, but may also lead to the accidental removal of surgical dressings, IV catheters, and drains. is one of the The purpose of the study is to find whether duration of exposure to Sevoflurane has any effect on the incidence of Emergence Delirium.


Eligibility Criteria:
Inclusion Criteria:

* age between 1-6 years of age
* receiving general anesthesia for non-surgical procedure

Exclusion Criteria:

* history of emergence delirium
* severe CNS disease
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas

The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are:

What are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)?

Participants will:

Take BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight

This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.

Eligibility Criteria:
Inclusion Criteria:

* must be age ≥18 years
* must have a diagnosis of relapsed or refractory mature B cell lymphoma
* must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)
* must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* must have a predicted life expectancy of ≥3 months
* must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566

Exclusion Criteria:

* has primary CNS lymphoma
* has ongoing toxicities from prior anti-cancer treatment \> Grade 1
* has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation
* has received any anti-cancer therapy (including radiation of curative intent) \<28 days prior to administration of BTM-3566
* has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).
* is pregnant or breastfeeding
Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study

The purpose of this study is to determine the safety and efficacy of the medication Baclofen for treatment of muscle cramps in patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
* Presence of muscle cramps on a regular basis

Exclusion Criteria:

* Allergy or hypersensitivity to Baclofen
* Active or untreated Portosystemic encephalopathy
* Active alcohol or substance abuse
* Age less than 18
* Pregnancy
* Concomitant use of narcotic pain medication, other muscle relaxer, or other anti-spastic agent
* Concomitant use of Tricyclic Antidepressant due to drug interaction
* History of chronic kidney disease defined by GFR \< 30 (using MDRD equation)
* Subject is institutionalized or a prisoner
* Inability or unwillingness to give informed consent
* Expected lifespan less than 3 months
* Severe or poorly controlled coexisting medical conditions or other significant issues as determined by the principal investigator to hinder the ability to adhere to study protocols
Muscle Evaluation Using Ultrasound in the Critically Ill

Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction.

Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients.

The aim of the present study is to constitute an image bank and to describe the muscle mass and function recovery in critically ill patients.

Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction.

Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients.

The aim of the present study is to constitute an image bank and to describe the mass and function recovery in critically ill patients.

Ultrasound and clinical data will be collected and analysed during the ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with at least one organ failure defined, organ failure being defined by a SOFA equal or above 3 for the organ, and an expected duration of ICU stay equal of above 3 days

Exclusion criteria:

- Pregnancy, age below 18, absence of consent
Chronic Kidney Disease in Pakistani Population

The Indo-Asian developing countries are facing an epidemic of chronic diseases including hypertension, diabetes and chronic kidney disease (CKD). Diagnosis of early CKD is essential for institution of effective and timely prevention of its complications; costly late stage treatment for end stage renal disease is currently an unfeasible option in these populations. GFR estimates of kidney function provide a common reference standard for all people and are therefore readily applicable by physicians and understood by patients. However, the existing GFR equations yield widely discrepant results in the Indo Asian population, and none of the currently available estimating equations have been validated in this population.

The main objective is to develop a tool which can be used for screening subjects at high risk for developing CKD (with hypertension and diabetes) as well as the general population.

The proposed study is being conducted at the Aga Khan University in collaboration with Tufts-New England Medical Center and Imperial College, UK. It is a population based cross-sectional study using a 2-stage cluster design. The study would be performed on 650 adult subjects from the general population in Karachi.

A new GFR equation specific to a Pakistani population would be developed and validated using the gold standard of measured Insulin GFR. The performance of the new equation will be compared to the existing ones developed in other populations with respect to bias, precision, and accuracy.

The project is likely to contribute significantly to moving the field to kidney disease forward, and its results are likely to have far reaching implications for understanding of CKD and, ultimately, its prevention in Indo-Pakistani populations worldwide.

Eligibility Criteria:
Inclusion Criteria:

* All individuals aged 40 years and above

Exclusion Criteria:

* Shortness of breath on minimal to moderate exertion
* Acute fibril illness
* Doctor diagnosed liver disease
* Doctor diagnosed rheumatological disease
* Heart attack within past three months
* Pregnancy
* Mentally incompetent to give informed consent
* Too frail to travel to clinic
* Bed ridden subjects