cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure

This study is a randomized clinical trial among colorectal surgery patients that will compare the efficacy of two different discharge protocols - current standard of care follow-up at two weeks post-op versus a 3-day phone call intervention. The overall aim of the study is to identify areas of improvement for discharging and following patients within 30 days of colorectal surgery.

This study will be a prospective clinical trial, in which colorectal surgery patients will be randomly assigned to a control or experimental group. Patients will be consented and randomized prior to discharge.The control group will be discharged with standard of care follow-up instructions described by The Ohio State University Wexner Medical Center (OSUWMC), and scheduled to come in for a standard follow-up clinic visit within 2-3 weeks. The experimental group will also be scheduled for a 2-3 week post-op follow-up appointment, but will also receive a phone call 3-days post procedure. During this phone call, the patient will be asked questions using a study-specific questionnaire that is based on the most frequent indications for readmission after colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled 2-3 week post-op appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately. To determine if patients had visited an ED or been readmitted to a hospital within 30 days of colorectal surgery, both the standard of care and intervention groups will receive a phone call 30-days post-discharge. At this time we will also conduct the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey to measure patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years old
* Patients who underwent colorectal surgery at The Ohio State University Wexner Medical Center

Exclusion Criteria:

* Patients under 18 years old
* Patients with limited ability to communicate
* Patients who do not have a telephone
A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and free from clinically significant illness or disease
* Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
* A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2

Exclusion Criteria:

* Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, neurological, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
* Clinically relevant abnormal medical history, physical findings or laboratory values
A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.

It is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered SKLB1028 as a single agent given daily for 28 days. Cohorts of 3 patients receive SKLB1028 until dose limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD is determined. Patients not experiencing DLT or significant disease progression could continue receiving SKLB1028 up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be provided.
* Males and females age ≥ 18 years;
* Histopathologically documented primary or secondary AML, as defined by WHO criteria, confirmed by pathology review at treating institution, meeting at least one of the following:

  1. Refractory to at least 1 cycle of induction chemotherapy, or
  2. Relapsed after at least 1 cycle of induction chemotherapy, or
  3. Patient is not, according to the clinical judgment of the Principal Investigator, a candidate for induction chemotherapy due to age, comorbidity, or other factors;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
* In the absence of rapidly progressing disease, the interval from prior treatment to time of SKLB1028 administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents;
* Serum creatinine ≤1.5 × ULN;
* Total serum bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's syndrome or leukemic organ involvement;
* Serum AST or ALT ≤ 3.0 × ULN unless considered due to leukemic organ involvement;
* Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study;

Exclusion Criteria:

* Histologic diagnosis of acute promyelocytic leukemia;
* Clinically active central nervous system leukemia;
* Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher;
* Bone marrow transplant within 100 days prior to study;
* Active, uncontrolled infection;
* Major surgery within 4 weeks prior to study;
* Radiation therapy within 4 weeks prior to study;
* Left ventricular ejection fraction ≤1 × ULN,or﹤50%. Clinically significant ECG QTc prolongation (Male: \>450ms, Female: \>470ms).Significant cardiac disease.
* Human immunodeficiency virus positivity;
* Active hepatitis B or C or other active liver disease;
* Women who are pregnant, lactating;
* Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study.
Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed the previous double-blind,randomized study.
* Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so.

Exclusion Criteria:

* Dose of prednisone\>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation.
* Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.
A Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A +/- High-Energy Visible Blue Light Exposure

The objective of this study is to assess the level of pigmentation following an acute exposure of skin to light regimens representative of portions of the natural sunlight spectrum and that contain Deep UVA wavelengths with or without HEV Blue Light, as compared to non-irradiated control skin.


Eligibility Criteria:
Inclusion Criteria:

* Uniform skin color over the whole test area (the lower back) with minimal variation between test sites.
* At least 3 subjects per skin type, as defined by self-reported reaction to sun exposure and Chromameter measurements.
* Generally in good health.
* Able to read, write, speak, and understand English.
* Intends to complete the study and is willing and able to follow the subject responsibilities.

Exclusion Criteria:

* In another study without approval by the study site.
* Has known allergies or negative reactions to common topical skincare products or UV light.
* Has a history of abnormal responses to sunlight or UV radiation.
* Has used a tanning bed/lamp, has had extended sun exposure of the test area, or has participated in a UV exposure study within the past 4 weeks.
* Has a current illness/condition/situation, a medical history of a disease/condition, or a skin condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, etc.) that could confuse the study results, interfere with participation, or increase health risk to the subject, as determined by the study investigator.
* Has shaved/waxed the test area within 2 weeks before Visit 1.
* Has used any products in the test area within 24 hours before Visit 1.
* Has sunburn, suntan, scars, tattoos, active dermal lesions, nevi, or other conditions in the test area that could confuse the study results or increase health risk to the subject, as determined by the study investigator.
* Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
* Is immunosuppressed (such as HIV-positive, transplant patients, undergoing chemotherapy or radiotherapy, etc.).
* Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results
* Has a personal or family history of skin cancer.
* Skeletal protrusions and/or extreme areas of curvature in the test area.
* Is pregnant, nursing, or planning to become pregnant.
* Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma

The study evaluates impact of high dose radiation on overall survival in patients with unresectable nonmetastatic cholangiocarcinoma. The study randomizes patient between systemic chemotherapy alone and systemic chemotherapy and high dose radiation

Currently the standard of care of unresectable non-metastatic cholangiocarcinoma is chemotherapy which has a median survival of 11.7 months (ABC-02 study). While this study included almost 60% of patients with cholangiocarcinomas (intrahepatic, extra hepatic and hilar), almost 73-76% of patients in each arm had metastases to begin with. And while the overall survival of the entire cohort was significantly improved by gemcitabine plus cisplatin compared to cisplatin alone, the hazard ratios for intrahepatic {0.57 (0.34-0.94)}, extra hepatic {0.73 (0.43-1.23)} and hilar cholangiocarcinomas {0.59 (0.32-1.09)} were all insignificant. Even though concurrent chemoradiation+/= brachytherapy has been used for management of cholangiocarcinomas for more than 3 decades the lack of level I evidence prevents from it being recommended as the first line management across multidisciplinary clinics.

While either modality alone rarely yields survival of more than 12 months, recent reports of improved median survival with combination of high dose radiation and systemic chemotherapy necessitates investigation into role of combination of high dose (chemo) radiation and systemic chemotherapy.

All patients with diagnosis of nonmetastatic unresectable cholangiocarcinoma who fulfill the study eligibility criteria will be evaluated for study participation. Patients will undergo upfront randomization into one of the study arms (systemic chemotherapy alone vs Systemic chemotherapy+ High dose radiation) The study stratification criteria will be done according the primary site i.e. Intrahepatic vs Extrahepatic.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Performance Status 0-2
* Tissue diagnosis of adenocarcinoma of the biliary tract. Wherever tissue diagnosis is not feasible in spite of repeated attempts a multidisciplinary consensus on clinicoradiological diagnosis of cholangiocarcinoma (CA 19-9= 100mg/ml with a radiological evidence of malignant stricture) should be made and patients consent should be available for treatment without tissue diagnosis.
* Unresectable disease as determined by hepatobiliary surgical team.
* No evidence of peritoneal or distant metastasis.
* No radiological evidence of paraaortic nodal disease.
* Child A or Child B (score 7)
* Ability to tolerate radical treatment.

Exclusion Criteria:

* Multicentric intrahepatic cholangiocarcinoma (however adjacent satellite lesions are permitted)
* Inability to deliver safe radiation due to high tumor/ liver ratio.
* Active cholangitis.
* Expected Survival\<6 months.
* Unresolved biliary tract obstruction.
* Inability in deliver systemic chemotherapy (persistent bilirubin\>3)
Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis

Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis

Diagnosed EKC patients will be devided into two groups,first group will undergo povidone-iodine 2% eye drop four times a day and the control group will be treated only by artificial tear drops,they will be examined 3 months later and evaluations and data collections for the final comparison will be done.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected for viral conjunctivitis

Exclusion Criteria:

* Allergic to iodized materials
* Age under 17
Diaphragm Stretching Increases Spine and Thoracic Mobility

Physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to spinal pathologies. The aim of this study was to evaluate the effect of diaphragmatic stretching on spine and thoracic movement in healthy adults.

Spinal pain is a well recognized condition associated with significant personal and community burdens. Recent studies estimated the prevalence between 6 and 22% in neck pain, from 4-72% in thoracic pain and from 1.0% to 58.1% in low back pain, which increases with age. During the last decades numerous researches have been conducted on stretching effects, evidencing an increased muscle control, flexibility and range of motion. The main purpose of this investigation is to examine the effects of diaphragm stretching in spine and thoracic mobility in healthy subjects in order to apply the results in a specifics pathologies in future studies.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Age: between 18 and 65 years old.

Exclusion Criteria:

* Pathological subjects
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients

The lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in schizophrenia is associated with negative consequences. Unfortunately, there no clear guidelines for the pharmacological treatment of this dual diagnosis population. Preliminary results suggest that second-generation antipsychotic drugs (mainly clozapine) may relieve drug cravings in schizophrenia. We performed a 12-week pilot study to evaluate the impact of quetiapine, a second-generation antipsychotic, on substance abuse parameters, psychiatric symptoms and side effects in patients schizophrenia and comorbid substance use disorders. Our expectation was a 20 % decrease in drug cravings from baseline to end-point.


Eligibility Criteria:
Inclusion Criteria:

* Patients with as schizophrenia spectrum disorder
* Patients with a comorbid substance use disorder

Exclusion Criteria:

* Patients already on quetiapine or clozapine
* Patients hospitalized or acutely ill
* Total score lower than 65 on the PANSS
* Pregnancy
* Female subjects of childbearing potential without adequate contraception
* Abnormal liver function (hepatic enzymes more than 3 times the upper normal limits)
* Any clinically meaningful unstable renal, hepatic, cardiovascular, respiratory, cerebrovascular disease or other serious, progressive physical disease.
Transformation of Somatosensory and Visual Coordinate Systems

Manipulation of object is a multisensory experience that includes tactile motion between the object and the fingerpad, visual motion elicited by the motion the object and the movement of the hand, and the active motor commend to control upper limb and hand conformation. It remains to be determined how such a complex interaction between touch and vision could be achieved effortlessly. In the present study, we will investigate how the motion information is transformed between touch and vision using the most novel approaches in human psychophysics, neuropsychology and monkey neurophysiology. Specifically, we will present tactile motion on primate fingerpads using a recently developed ball stimulator with a design in which we vary the direction of motion with respect to the skin surface and also vary the hand conformation and position. This setup allows us to systematically sample the possible scenarios involving coordinate transformation between the somatosensory and visual systems in conditions that could occur in hand exploration and object manipulation in daily life. We will present these tactile stimuli on normal human subject as well as stroke patients such as patients with spatial hemineglect. Finally, we will record from macaque monkeys in cortical areas that are thought to underlie the transformation of coordinates, such as the primary somatosensory cortex and posterior parietal cortex. The results of the present study will contribute to the understanding of multisensory integration and the rehabilitation for patients with impaired use of spatial information.


Eligibility Criteria:
For stoke patients

Inclusion Criteria:

* stroke patients
* stable medical condition
* can cooperate in evaluation

Exclusion Criteria:

* peripheral neuropathy
* limb ambulation
Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation

Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. The primary endpoint is the feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven diagnosis of a hematologic malignancy
* Scheduled to undergo allogeneic SCT from a matched sibling donor or an unrelated donor who is 10/10 or 9/10 HLA match. Transplant eligibility is per standard and institutional criteria.
* Age 18-60 years
* Willing and able to provide informed consent

Exclusion Criteria:

* Documented or reported contrast allergy
* Estimated glomerular filtration rate (GFR) \< 60
* Deemed too sick by clinician to leave the floor for imaging
* "Nothing-per-mouth" status for other clinical reasons

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this trial.
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression

The aim of this trial is to investigate the effects of a single bout of aerobic exercise on sleep in patients with depression.

PRIMARY OBJECTIVE:

The primary objective of this study is to evaluate whether a single bout of aerobic exercise improves sleep efficiency more than a control condition in patients with depression.

SECONDARY OBJECTIVES:

Secondary objectives are to assess the effects of a single bout of aerobic exercise on 1) sleep continuity, 2) sleep architecture, 3) pre-sleep arousal, 4) subjective sleep quality, 5) daytime sleepiness, 6) nocturnal blood pressure, 7) heart rate variability, and 8) the frequency and severity of adverse events.

DESIGN:

This will be a two-arm parallel group, randomized, outcome assessor blinded, controlled, superiority trial. According to sample size calculation a total of 92 patients will be randomized using minimization. The trial will take place in the first five days of the patients' psychosomatic in-patient rehabilitation in the clinic OBERWAID, St.Gallen, Switzerland. The study visits are scheduled is as follows:

Day 0-2: Screening, inclusion, and graded exercise test to determine exercise intensity of intervention

Day 3: Questionnaires for background information

Night 1 (day 3-4): Baseline polysomnography and sleep related questionnaires

Day 4: Randomized allocation (control or exercise condition) and performing corresponding intervention

Night 2 (day 4-5): Follow-up polysomnography and sleep related questionnaires

Day 5: Daytime sleepiness questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Inpatient psychosomatic rehabilitation in the clinic OBERWAID, St.Gallen, Switzerland
* Age: ≥18 and ≤65 years old
* Primary diagnosis of depression (F32, F33) without psychotic episode according to International Statistical Classification of Diseases, 10th edition

Exclusion Criteria:

* Regular use of hypnotic agents (patients were included if no hypnotic agents were taken 2 weeks prior to study participation)
* Factors precluding exercise testing or training
* Use of beta-blockers (with the exception of Carvedilol \& Nebivolol)
* Use of opioids
* History of epilepsy
* Restless legs syndrome defined by ≥7 points on the restless legs syndrome screening questionnaire (RLSSQ)
* Moderate or severe sleep apnea defined by an oxygen desaturation index (ODI) ≥15 in the first polysomnography.
* Morbid adiposity with BMI \>40
Impact of Myofascial Release on Preventing Dysphagia in the Elderly Community

The goal of this clinical trial is to explore the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation.

The goal of this clinical trial is to explore the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.
* Dysphagia

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Difficulty in mobility.