cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate Acute Respiratory Virus Infections in Participants at High Risk for Severe Illness

The purpose of the study is to describe the rate of occurrence of clinical diagnosis of acute respiratory infection (an infection that affects normal breathing) and different types of respiratory pathogens (harmful organisms) of new respiratory infections in a population at high risk for severe illness.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent form (ICF) indicating understanding the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study
* Participants at high risk for severe respiratory infections due to their immune-suppressive status and who fit in one or more of the following categories: a) Participants with hematologic malignancy (HM) including, but not limited to, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), multiple myeloma (MM): i) Newly diagnosed, within 6 months of treatment initiation; including anticipation of cytotoxic and immunomodulatory therapy such as chimeric antigen receptor T (CAR-T) ii) Hematologic relapse within 6 months from anticipating treatment initiation for relapse iii) Participants with a history of HM who have maintained the immunosuppressive status in the opinion of the investigator and after consultation with the sponsor (that is, study responsible physician or scientists) b) Participants with a history of HM who have received hematopoietic cell transplant (HCT) within 1 year for autologous recipients or within 3 years for allogeneic recipients. c) Participants with a non-HM who have received HCT within 1 year for autologous recipients or within 3 years for allogeneic recipients. This can include, but is not limited to, participants who have received HCT due to lymphoproliferative disorders, solid tumors, primary immunodeficiency, bone marrow failure syndromes, hemoglobinopathies, sickle cell disease, or autoimmune disorders. d) Participants who have developed chronic graft vs host disease (GVHD) after HCT and are currently on immunosuppressive therapy
* Must be able to read, understand, and complete questionnaires
* Must be willing and able to connect current electronic health records from one or more providers

Exclusion Criteria:

* Has a clinical condition other than those specified in inclusion criterion 3 which, in the opinion of the investigator, could prevent, confound, or limit the protocol-specified assessments (for example, asthma and allergies)
* Is, in the opinion of the investigator, unlikely to adhere to the requirements of the study or is unlikely to complete the full course of observation
* Cannot communicate reliably with the investigator
* Has moderate-severe allergies that add complexity to the assessment of acute respiratory infection (ARI) episode
* Is currently enrolled in an interventional study that could interfere with the assessment of respiratory viral dynamics
Is There a Link Between Inflammation and Endocrinopathies in Turner Syndrome?

Liver abnormalities are common in Turner syndrome. The physiopathology of these abnormalities is unknown for the moment but their potentially serious evolution requires additional explorations.


Eligibility Criteria:
Inclusion Criteria Experimental group:

* Turner syndrome

Inclusion Criteria Control group:

* healthy subjects
Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis.

Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years old." Ten percent of the population will get this disease during a lifetime." At Bispebjerg hospital it is one of the most common acute surgeries performed. Though at Bispebjerg hospital the surgery is only performed on adults as there is no pediatric ward. The surgical technique is primarily laparoscopic surgery, where the patients have their appendix removed while in general anaesthesia. During the last three years Bispebjerg hospital has had an average of 287 patients per year undergoing laparoscopic surgery. From January to the September 2012 a total of 211 patients have had the operation, with 29% having the operation performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only performed in cases where laparoscopic surgery is impossible, this is often due to adhesions, scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery are usually smaller than that from an open appendectomy, but it gives the patient three smaller scars divided on three abdominal quadrants instead of one larger scar on one quadrant.

The investigators want to conduct a clinical trial with fifty six patients undergoing laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is possible to improve the post-operative pain management within this very large group of patients undergoing acute surgery. In detail, the investigators wish to explore whether the use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery due to acute appendicitis, can anesthetize the patients completely or partially, so they can avoid morphine intake completely or partially during the post-operative phase (12-24 hours). The research project will be a randomized, double-blinded, controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Patients undergoing diagnostic laparoscopy for acute appendicitis
* American Society of Anaesthesiology group 1-3
* General Anaesthesia

Exclusion Criteria:

* Inability to cooperate
* Inability to understand and talk danish
* Allergic to ropivacaine
* Drug and alcohol abuse
* Pregnancy or nursing
Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma

This study is for patients with advanced ovarian cancer that has reappeared after treatment with conventional therapy. The purpose of this study is to determine if the combination of docetaxel and gemcitabine will be effective in reducing or eliminating the tumor(s) in patients with ovarian cancer.

Docetaxel is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancer; gemcitabine is approved by the FDA for the treatment of pancreatic and lung cancer. Neither docetaxel nor gemcitabine are approved for the treatment of ovarian cancer. Both drugs have been shown to decrease the size of ovarian cancer tumors.

Primary Objective:

1. To determine the response rate, time to progression and survival (secondary) of the combination of docetaxel and gemcitabine administered on a weekly basis to patients with platinum-resistant ovarian cancer

Secondary Objective:

1. To determine the toxicity of this combination regimen in patients with platinum-resistant ovarian cancer
2. To evaluate the toxicity and safety profile of a short course (one dose) of premedication with steroids to patients receiving weekly gemcitabine and docetaxel

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Treatment repeats every 21 days until PD, unacceptable toxicity, or patient's withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of epithelial ovarian ca
* Must have platinum-resistant disease. (Defined as progression during the most recent platinum-based chemotx or relapse \< 6 months after the most recent platinum-based chemotx regimen.)
* Measurable or evaluable disease. (Patients whose dz is manifested only as an elevated CA-125 \[greater than or equal to 100\] are eligible. If an elevated CA-125 is the only manifestation of dz, it must be confirmed on 2 separate times, at least 2 weeks apart. Patients with positive cytology only are not eligible.)
* Greater than or equal to 18 years of age
* GOG performance status less than or equal to 2
* AGC/ANC greater than or equal to 1.5; platelets greater than or equal to 100,000; hemoglobin (Hgb) greater than or equal to 8.0.
* Creatinine less than or equal to 2.0
* Total bilirubin less than or equal to upper limit of normal (uln)
* SGOT and/or SGPT less than or equal to 2.5 x uln if alkaline phosphatase less than or equal to uln, or alkaline phosphatase less than or equal to 4 x uln if transaminases are less than or equal to uln. (If both SGOT/SGPT \>1.5 x uln and alkaline phosphatase \> 2.5 x uln, patient is not eligible.)
* Fully recovered from acute toxicities secondary to prior treatment (tx)
* Signed informed consent

Exclusion Criteria:

* Prior treatment with gemcitabine or docetaxel
* Underlying medical, psychiatric, or social conditions that would preclude patient from receiving treatment
* Peripheral neuropathy greater than or equal to Grade 2
* No prior tx with cisplatin or carboplatin
A Comparison Between Propofol and Etomidate in Hysteroscopy on Effect of Postoperative Sedation and Cognitive Function in Elderly Patients

To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly patients


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 60 and 80 years
2. Selective hysteroscopic operation
3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
4. Signed informed consent form
5. Expected operation duration is within 60 minutes

Exclusion Criteria:

1. Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis
2. Long use of hormone or history of adrenal suppression
3. Allergy to trial drug or other contraindication
4. History or expected difficult airway
5. Identified, suspected abuse or long use of narcotic analgesia
6. Neuromuscular diseases
7. Mentally unstable or has a mental illness
8. Dysfunction of communication
9. Trend of malignant hyperthermia
10. Pregnant or breast-feeding women
11. Attended other trial past 30 days;
Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss

Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the effects of weight loss on dyspnea are not completely understood. The objectives of this study were to examine the relationships between exercise parameters and dyspnea in obesity and assess the effects of weight loss.

The investigators compared pulmonary function, exercise performance and dyspnea in 34 patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched controls. The study also assessed within-group changes in physiology and symptoms in a subset of patients following participation in a weight management program.

Because obesity is a heterogeneous condition, with variable genetic associations, co-morbidities and distributions of adipose tissue, the study focused on patients with abdominal obesity who met diagnostic criteria for metabolic syndrome.

The study has two parts: first, the investigators compared dyspnea, pulmonary function and exercise measurements between obese patients and control subjects with normal weight; then, the investigators assessed the effects of medical weight loss in the obese group on these parameters. Baseline dyspnea was assessed using the baseline dyspnea index.The effect of weight loss on dyspnea was assessed using the transitional dyspnea index. The main physiologic measurement of interest was the inspiratory capacity (L, measured at rest and during exercise).

Eligibility Criteria:
Inclusion Criteria:

* Individuals accepted into the behavioural weight management program at the Ottawa Hospital Bariatric Centre
* Age between 20 and 60 years
* BMI greater than 30
* Abdominal girth (for females) greater than 88 cm
* Abdominal girth (for males) greater than 102 cm
* Plus any two of the other criteria for Metabolic Syndrome:

  i.e. Blood Pressure greater or equal to 130/85; Fasting Glucose greater or equal to 6.1 mmol/L
* Controls-normal weight (NW) and sedentary

Exclusion Criteria:

* Smoker
* Any medical conditions which would affect exercise performance
* Use of medications that could affect exercise performance (i.e. Beta-blockers)
* Inability to pedal on a cycle ergometer and provide reproducible inspiratory capacity (IC) measurements
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI

The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation.

The hypothesis is that a prolonged HV-interval is associated with a high rate of complete AV-block following TAVI.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic aortic valve stenosis
* patients screened for TAVI
* written informed consent

Exclusion Criteria:

* unconsciousness, not able to consent
* \< 18 years
* permanent pacemaker
Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).

To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.

Eligibility Criteria:
Inclusion Criteria:1) Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.

2) Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.

3) Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.

4) Patients with secondary myelodysplasia following cytotoxic chemotherapy. Exclusion Criteria:- Organ dysfunction
Clinical Outcomes Following Total Joint Replacement With Corin Prostheses: Corin MetaFix Collared Stem

Assessment of the clinical performance and survivorship of the Corin Total Hip System with Trinity™ cup MetaFix™ Collared stem in a prospective study. The primary endpoint of the study is to evaluate the 3-year survivorship and clinical performance of the Corin Total Hip System using Trinity™ cup and MetaFix™ Collared stem. Additionally, the study follow up will continue until 10 years for subjects who consent to do.

The primary objective is the 3-year survivorship of the study devices.

The Secondary Objectives include:

* The improvement of clinical outcomes:

  * Oxford Hip Score (OHS) up to 10-year follow-up
  * Harris Hip Score (HHS) up to 10-year follow-up
  * Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up
* Safety performance monitoring including hip- and device-related AEs and the revision rate up to 10-year follow-up

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a THR

Exclusion Criteria:

-
Intended Use Study of the BD SurePath Plus™ Pap

This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to undergo colposcopy and biopsy/ECC. Subjects with abnormal cytology results with biopsy results of less than or equal to CIN1 or CIN2 untreated will be asked to return in 6-8 months for follow-up testing. Subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).

This is a pivotal, multi-center in vitro diagnostic study comparing the BD SurePath Plus Pap test to current practice (cytologic examination utilizing the BD SurePath liquid-based Pap test with conjunctive HPV testing) for the detection of cervical cancer and high-grade cervical disease (collectively referred to as CIN2+) in women.

The new BD SurePath Plus Pap Test combines a traditional Papanicolaou staining for cellular morphology, with brown nuclear immunostaining resulting from the over-expression of specific protein biomarkers, on one slide, to improve the detection of high-grade cervical disease and cervical cancer (collectively referred to as CIN2+).

Eligibility Criteria:
Inclusion Criteria:

Study subjects must give voluntary written informed consent to participate in this study.

- Females ages 18 - 35 years, inclusive; or women at high- risk for cervical cancer or its precursor lesions.

High-risk is defined as:

* Have had a previous high-risk HPV positive test in the last 5 years; or
* Have had an abnormal Pap test (ASC-US or higher) in the last 5 years; or
* Have not been screened for cervical cancer by either a Pap test or HPV test in the last 5 years.

Exclusion Criteria:

* Subjects who are 36 years of age or greater who are not high risk, and/or:

  1. Have not had an abnormal Pap in the last 5 years; or
  2. Have not had a positive HPV test in the last 5 years; or
  3. Have been screened in the last 5 years without an abnormal Pap or HPV result
* Subjects known to be pregnant or planning to become pregnant prior to the potential six months follow-up visit (self-reported). Subjects who decide to become pregnant prior to the six-month follow up visit or found to be pregnant after the first visit, but prior to the six-month follow-up visit will be terminated from further study participation at that time
* Subjects who have had a prior complete or partial hysterectomy involving removal of the cervix.
* Subjects who have had an application of chemical compounds to the cervical area within the 24 hours prior to study entry, e.g., acetic acid, iodine, spermicide, douche, anti-fungal medications, etc.
* Subjects on whom conization, LEEP, laser surgery, or cryosurgery has been performed within the past five months.
* Subjects currently undergoing radiation and/or chemotherapy.
* Subjects under the age of 18.
* Subjects who have previously received a HPV vaccine with any number of doses.
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery.

In this proposed study researchers will:

1. Measure preoperative energy reserve capacity (fitness)
2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism

Primary Objective:

• To characterize the effects of neoadjuvant therapy (chemotherapy, radiation therapy, and/or immunotherapy) on functional capacity in esophageal and lung cancer participants as measured by gas exchange parameters (%predicted AT, %predicted P-VO2, VO2 at AT \& peak exercise, oxygen pulse, ΔVO2/ΔWR, ΔVE/ΔVCO2) obtained from CPET before and after neoadjuvant therapy.

Secondary Objectives:

• To characterize changes in CPET measures in participants treated with chemotherapy, radiation therapy, and/or immunotherapy followed by surgery and correlate these changes with postoperative outcome.

Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years of age or older.
* Participants with newly diagnosed esophageal and lung cancer undergoing neoadjuvant chemotherapy, radiation therapy, and/or immunotherapy.
* Participants who have signed the consent form to participate in the study.
* Participants must have been evaluated in the Perioperative Evaluation and Management (POEM) Center or by a staff Anesthesiologist.
* All laboratory and diagnostic evaluations required or used to evaluate the patient must be completed. All participants must be approved to undergo anesthesia by the standards of the POEM Center.
* No samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults or prisoners) will be allowed from participation.

Exclusion Criteria:

* Participant is under age 18.
* Participant is unwilling to sign consent.
* Participant is unable to exercise (bedridden or wheel chair bound).
* Participant is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC.
* Participant's condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.
* Participant has had a myocardial infarction within three months of the preanesthetic evaluation or presents with new or unstable angina.
* Participant has a history of a cerebrovascular accident or transit ischemic attacks within three months of the preanesthetic evaluation.
* Participant has a history of a pulmonary embolic event within three months of the preanesthetic evaluation.
* Participant is known to have acute or chronic deep vein thrombosis.
* Participant is pregnant.
Community Support Program for Lung Cancer Screening

The research study aims to create a program for lung cancer screening attendance

The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improving adherence to LCS follow-up guidelines in an urban environment. The project aims to collaborate with community partners to develop an infrastructure and iterative process to provide social support to community members that facilitates obtaining their follow-up LDCT for LCS. It utilizes novel population level data that includes geospatial analysis of neighborhood-level data of patients residing in Philadelphia who have received a LDCT for LCS. This allows for targeted community level interventions and the ability to evaluate impact on a population level.

A Community Support Program Representative will reach out to eligible patients via telephone. The CSP Representative and Patient Navigator will communicate with consented patient directly, assist with travel and the appointment. The PN will log the date of the appointment, zip code of the patient and the adherence (or lack of) of the appointment completion. We will utilize Lyft transportation vouchers to provide rides to participants from their home location in West Philadelphia to and from the Penn Medicine downtown hospital locations on the day of their LDCT.

Eligibility Criteria:
Inclusion Criteria:

* Upcoming or missed follow-up LDCT (low dose CT)
* West Philadelphia resident
* Between 18-89 years' old

Exclusion Criteria:

* No upcoming LDCT
* Lives outside West Philadelphia
* Outside age range
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.


Eligibility Criteria:
Inclusion Criteria:

1. Must provide written, signed informed consent for this study.
2. Must have been enrolled in a previous clinical study of RGX-314 in the treatment of nAMD and must have received an SCS injection of RGX-314 in that study.
3. Must be willing and able to comply with all study procedures.

Exclusion Criteria:

1. None