cyrilzakka/clinical-trials huggingface dataset:
Cone Beam CT Guided Transbronchial Cryobiopsy

Interstitial lung diseases (ILD) are common in clinical practices and need multidisciplinary assessment of clinical presentations, radiological and histological features. Transbronchial cryobiopsy (TBCB) is one of the most important invasive procedures for ILD when a confident diagnosis cannot be made by clinical and radiological assessment. TBCB could lead to higher incidence of risks. The pneumothorax and severe bleeding seemed to be more common in patients with TBCB.

Cone-beam computed tomography (CBCT) could provide 3-dimensinal (3D) CT images which were close to the image qualities of conventional CT. The probe-to-pleura relationship could be accurately established by the 3D CT scan and the cryobiopsy safety profile might be improved under the guidance of CBCT. In this study, we conducted a prospective study to observe the safety and diagnostic efficacy of CBCT guided TBCB for the DPLD patients.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35%

Exclusion Criteria:

* acute exacerbation within one month, bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients with pulmonary hypertension, respiratory failure, liver, kidney disfunction, and cardiac insufficiency, PLT less than 50 x 109/L
Skin Conduction Device and Patient Diary for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes

RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary.

PURPOSE: This clinical trial is studying a skin conduction device and a patient diary for measuring hot flashes in postmenopausal women with hot flashes.

OBJECTIVES:

* Determine the differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary in postmenopausal women with hot flashes.
* Assess the recordings made by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period in these patients.

OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 24 hours.

Patients complete hot flash diaries over 24 hours. Patients undergo treadmill exercise over 30 minutes and record hot flash activity using the skin conductance device during 10 minutes of sweating. Patients also complete the Comfort, Bother, and Weight Questionnaire at the completion of the study.

PROJECTED ACCRUAL: A total of 3 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of bothersome hot flashes, defined by their occurrence ≥ 4 times/day

  * Daily hot flashes that have been present for ≥ 1 month

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal
* ECOG performance status 0-1
* No history of allergic or other adverse reactions to adhesives
* No other medical condition known to cause sweating and/or flushing
* No implanted pacemakers or metal implants
* No reliance on electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors)

PRIOR CONCURRENT THERAPY:

* Not specified
Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.

This trial is a multicenter prospective cohort study to explore timing of colorectal cancer surgery after COVID-19 infection so that can assist clinicians and patients. Currently, there is less evidence on perioperative outcomes after COVID-19 vaccination and the omicron variant. Therefore, it is necessary to update previously published consensus which recommends that patients should avoid elective surgery within 7 weeks of COVID-19 infection remain, unless the benefits of doing so exceed the risk of waiting. Aiming at the above problems, we plan to carry out a multicenter prospective cohort study to develop perioperative management according patients' different conditions.


Eligibility Criteria:
Inclusion Criteria:

* undergoing colorectal cancer surgery
* infected with COVID-19 but nucleic acid test result is negative
* the patients compliance is good
* signed the consents voluntarily

Exclusion Criteria:

* undergoing emergency surgery(intestinal obstruction, intestinal perforation, intestinal hemorrhage, et al.)
* The patients' situations which judged by situations is not suitable to participate in the clinical trial
Zanubrutinib for HLH

This study is a prospective single-arm clinical study, focusing on Hemophagocytic lymphohistocytosis，to evaluate the clinical efficacy and safety of zanubrutinib.


Eligibility Criteria:
Inclusion Criteria:

1. Unlimited gender, age ≥ 14 years old;
2. HLH was diagnosed according to HLH-04 diagnostic criteria;
3. Before the study, there was no severe liver function injury; Serum creatinine ≤ 1.5 times the upper limit of normal value;
4. Sign informed consent

Exclusion Criteria:

1. Allergic to zebutinib;
2. Currently active important cardiovascular diseases with clinical significance; The functions of important organs such as heart and lung unrelated to HLH were seriously abnormal;
3. Known human immunodeficiency virus (HIV) or active hepatitis B (HBV) or hepatitis C (HCV) infection;
4. Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial;
5. Serious mental illness;
6. Active massive hemorrhage of internal organs;
7. Uncontrollable infection;
8. At the same time, participate in other clinical researchers
Fall Prevention in a Geriatric Nursing Home Setting Using the Music of Nolwenn Leroy

Falls are the largest cause of death in the elderly and those with dementia have even a higher incidence of falling. The purpose of this study is to determine whether listening to the Music of Nolwenn Leroy is effective in fall prevention in those elderly patients who are residents in a Geriatric Nursing Home Facility. The music of Nolwenn Leroy has been shown to be effective in fall reduction in a different setting (Posturographic Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov Identifier: NCT00121693) )with results better than listening to Mozart of any other music.

Falls are a serious health issue and are the greatest cause of death in the elderly. The use of the music of Nolwenn Leroy in fall prevention has been reported at a major scientific meeting Posturographic Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov Identifier: NCT00121693) featured at the 7th Annual American Music Therapy Association Conference in Orlando, Florida, Nov 15-20, 2005 and is in publication in the indexed literature. Decreasing falls in a geriatric nursing home setting is associated with the saving of lives. We propose the utilization of the Nolwenn Effect in our resident geriatric population and comparing fall rates to those we have carefully recorded in the past.

Daily listening to selections from Nolwenn Leroy's CD "Nolwenn" have been played for one month in the community gathering areas of our fourth floor dementia unit in the morning for approximately 5-10 minutes. This unit has an increased rate of falls due to the characteristics of its residents and our one month retrospective study has demonstrated a statistical reduction in the rate of falls subsequent to the daily listening of Nolwenn Leroy music. We propose to expand the listening of music to the entire building and study the Nolwenn Effect on the fall rate of all residents over the calendar year 2006.

Preliminary observations have been associated with a decrease rate of falls on our dementia floor when compared to our previous fall rates. Our nursing staff is well trained in fall reporting and will continue to do so in the manner previously established before implementation of this study. This study is dependant upon the utilization of fall statistics previously established at our institution. The incorporation of these statistics will allow us to demonstrate a cost effective method of reducing falls that might save lives, evoke societal change and act as a model for other Geriatric Nursing Home settings.

Eligibility Criteria:
Inclusion Criteria:

* Full time resident in Geriatric Facility

Exclusion Criteria:

* All others
İmportance of Scattered White Spots Detected in the Duodenum and Their Relationship wıth Zonulin

With our study, we aimed to determine whether there is a correlation between zonulin, which plays a crucial role in intestinal barrier function and is implicated in the etiopathogenesis of many chronic and autoimmune diseases, and scattered white spots lesions associated with lymphatic stasis and inflammation in the duodenum.

During esophagogastroduodenoscopy (EGD), rarely encountered lesions in the duodenum present as scattered white spots (SWS) on the normal mucosa. Although not fully understood in terms of specific association with any particular disease and clinical significance, some studies have often observed chronic non-specific duodenitis (CND) and intestinal lymphangiectasia (IL) in lesions with SWS. This condition is thought to be related to lymphatic stasis.

Patients included 63 individuals with identified SWS during EGD and 30 patients with a normal appearance of the duodenal mucosa were selected as the control group. SWS lesions were categorized into two groups, grade 1 and grade 2, based on the degree of density and endoscopic appearance. Biopsies were taken from the duodenum, antrum, and corpus. It was examined for IL, CND, giardiasis, and villous atrophy. Venous blood samples were collected from all patients for serum zonulin levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients with scattered white patchy lesions in the duodenum on endoscopy and control group patients with normal duodenum on endoscopy.

Exclusion Criteria:

* active gastroenteritis
* acute kidney failure
* chronic kidney failure
* type-1 diabetes
* inflammatory bowel disease
* duodenal ulcer,
* duodenal tumor
* autoimmune diseases
Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis

The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. In the Feeling Hot 1 study the influence of environmental factors of overnight measurements are studied in a controlled setting. Healthy individuals will have visually aroused erections in different circumstances (naked, clothing, blankets) to determine the feasibility of this new measurement method for nocturnal erection detection in the search to modernize erectile dysfunction diagnostics.

Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal erection detection with the RigiScan. The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock. In the search of modernizing erectile dysfunctions diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. With the absence of a pressure component, the patient experience should improve. Literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. However, it is unclear what the influence of environmental factors such as blankets and clothing is on the increase in penile temperature during erection. The Feeling Hot 1 study explores the effects of these environmental factors in a controlled setting to gain insight into the possibility of using temperature sensing to detect nocturnal erections.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 18 - 29 years
* Capable of getting visually arousable erections

Exclusion Criteria:

* Test subject unwilling to sign informed consent
* Test subject with erectile dysfunction
* IIEF-5 score below 17
* Medical history consisting of sickle cell anaemia, atherosclerosis and/or diabetes type I/II
High-intensity Interval Circuit Training in People With Parkinson Disease

The goal of the study is to compare different types of high intensity circuit exercises over an 8-class training series in people with Parkinson disease. The main question it aims to answer is:

-Does including arm and hand exercises with leg exercises improve reaction time, balance, functional measures, gait speed and quality of life? This group will be compared to a group that only does leg exercises. Participants will be asked to participate in 8 high intensity circuit exercise classes.

People with Parkinson disease will be recruited from the community and randomized into 2 equal groups: high intensity interval circuit training with lower extremity (LE) and lower and upper extremity (LEUE) training. The study will be composed of a baseline assessment, 8 group class sessions, and a post-intervention assessment. The baseline assessment will include demographics, disease and fall history and outcome measure collection. Group class sessions will include concurrent group warmup, followed by an 8-station circuit performed with high intensity intervals, and a cool-down. The circuit will include 4 stations performed by both the LE and LEUE groups and 4 stations specific to each intervention group, including 4 additional LE exercise stations for the LE group and 4 UE specific stations for the LEUE group. The stations that differ will not be adjacent to one another nor specifically indicated as different. The stations that differ will mirror similar aspects of function (ie, strength, reaction time, etc.) for the UE and LE stations. Participants will be told exercise stations may vary within-session and week to week but will not be informed that only one group has UE exercise interventions. After conclusion of the class series, post-intervention balance and stepping outcomes will be reassessed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Parkinson's disease
* Hoehn and Yahr level of 1 to 3
* ability to walk independently with or without an assistive device
* obtain medical clearance to participate in moderate or vigorous exercise.

Exclusion Criteria:

* diagnosis of any neurological disease other than PD (including but not limited to stroke, dementia, and multiple sclerosis; mild cognitive impairment is not excluded)
* bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis)
* muscle or ligament tears
* uncontrolled hypertension
* uncontrolled diabetes
* severe cardiovascular disease that impairs walking or exercise
* a major change in medication during the study training period (pre-test to post-test)
B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

This case-control study investigated B-vitamin and homocysteine in relation to the presence or the absence of type 2 diabetes and clinical signs of polyneuropathy.

Blood samples were collected and clinical investigations were performed at the same time.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with or without diabetes.

Exclusion Criteria:

* Usage of supplements containing B-vitamins, methotrexate treatment, cerebral or cardiac events in the last three months
* Liver or renal dysfunction.
Ain Shams University Experience: Clinical Determinants of Hospitalized COVID-19 Patients

COVID-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. So, it is important to investigate the Egyptian clinical characteristics and different factors that determine the patient's 'outcome

Investigators will convey the Ain Shams University experience as the first university in Egypt to designate one of its hospitals (Ain Shams University Obour Hospital) for management of confirmed COVID19 cases. investigators will try to identify the characteristics of the disease as regards the clinical, laboratory and imaging abnormalities and to assess the outcome determinants. It is a retrospective observational cohort study at Ain Shams University Obour Hospital. All adult patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2)will be included.

Clinical criteria, laboratory data, radiological findings, hospital course and patient outcome will be anonymously collected from records.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).
* Standard of care arm of the ongoing clinical trials will be included in our study.

Exclusion Criteria:

* mild cases who don't need hospitalization
Safety Study of SGN-CD70A in Cancer Patients

This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell lymphoma including Grade 3b follicular lymphoma
* Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
* Confirmed positive CD70 expression on tumor tissue
* Eastern Cooperative Oncology Group performance status 0 or 1
* Adequate baseline hematologic, pulmonary, renal, and hepatic function
* Measurable disease

Exclusion Criteria:

* Prior treatment with anti-CD70 directed therapy unless CD70 expression is confirmed on tumor tissue obtained after the treatment
* Patients \<100 days since prior allogeneic stem cell transplant
* Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease progression on the prior treatment
Energy Cost for Holding a MedGem® Indirect Calorimeter

The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device.

Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute rest (washout) period. The two RMR evaluation periods are as follows:

1. RMR with MedGem® Indirect Calorimeter
2. RMR without MedGem® Indirect Calorimeter

Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects will be introduced to the ventilated hood to determine presence of claustrophobia prior to enrollment (i.e., signing of the consent form).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 y
* BMI 25-40 kg/m2

Exclusion Criteria:

* Diabetes mellitus
* Current smoker
* Presently on a weight loss regimen
* Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs
* Claustrophobia
* Pregnant or breastfeeding
* Congestive heart failure
* Chronic kidney disease
* Pacemaker or other metal implants
Developing of Virtual Reality Based Neurologic Examination Teaching Tool(VRNET)

The purpose of this study is to evaluate the effect of the virtual reality based neurologic examination teaching tool(VRNET) for medical students. VRNET is a new teaching tool for neurologic examinations by offering different neurologic signs of the face, with which medical students can experience more realistic patients.


Eligibility Criteria:
Inclusion Criteria:

* 4th grade medical students of emergency medicine clerkship who agree with participation on this study.

Exclusion Criteria:

* Disagree with participation on this study.
* Who are absent the last day of clerkship.
A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best

Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.


Eligibility Criteria:
Inclusion Criteria:

* Women of at least 18 years of age at the time of signing of informed consent
* Women with endometriosis confirmed by at least one of the two criteria:

  * surgery within the last 10 years
  * imaging within the last 12 months
* moderate to severe pelvic pain which will be assessed over a period of 28 days
* Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain
* Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device \[IUD\] or commitment to abstinence) and refrain from using hormonal contraception

Exclusion Criteria:

* Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study
* Altered bilirubin metabolism and liver function at Visit 1
* Requirement to use pain medications for reasons other than endometriosis
* Contraindications to using ibuprofen
* Signs of hyperandrogenism
* Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
* History of hysterectomy, tubal-ligation or bilateral ovariectomy
* Uncontrolled thyroid disorder
Evaluation of A Novel Methodology in the Assessment of Urethral Function Using [S,S]-Reboxetine in Healthy Volunteers

\[S,S\]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in healthy volunteers using a novel methodology


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects, aged 18-65 years.
* Subjects must be non-pregnant and non-lactating, and be either post menopausal (greater than 1 year without menses), surgically sterilized, or using another acceptable form of contraception.
* Subjects of child bearing potential must have confirmed negative pregnancy tests at screening and prior to commencing all study periods.

Exclusion Criteria:

* Evidence or history of clinically significant disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).
* Subjects with any clinically significant abnormality following review of laboratory data, urinalysis and physical examination.
A Phase 1b Study of the Safety of REN001 in Patients With Fatty Acid Oxidation Disorders

The purpose of this Phase 1b study is to assess REN001 safety in subjects with fatty acid oxidation disorders.

This is a Phase 1b, open-label, multiple-dose study of the safety and tolerability of 2 dose levels of REN001 in subjects with fatty acid oxidation disorders (FAODs) with confirmed mutations in the Carnitine palmitoyltransferase II deficiency (CPT2), Very long-chain Acyl-CoA dehydrogenase deficiency (VLCAD), Long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency (LCHAD) or Trifunctional Protein Deficiency (TFP). All subjects will provide written consent prior to commencing any study related activities or assessments. Potential subjects will be screened for study participation up to 8 weeks prior to the start of dosing.The study is divided into two parts, Part A and Part B. Part A has finished enrollment and further eligible patients will participate in Part B only.

Eligibility Criteria:
Inclusion Criteria:

Subjects must give written, signed and dated informed consent

Confirmed diagnosis of FAOD

A diagnostic acylcarnitine profile, in blood or cultured fibroblasts

A stable treatment regimen for at least 30 days prior to enrollment

Exclusion Criteria:

Unstable or poorly controlled disease

Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer

Have been hospitalized within 3 months prior to screening for any major medical event

Pregnant or nursing females