cyrilzakka/clinical-trials huggingface dataset:
The Effects of Core Stabilization Exercises in Addition to Balance Exercises in Adult Hemophilia Patients on Balance, Quality of Life, Lower Limb Muscle Strength and Functional Level

The aim of this study is to investigate the effects of core stabilization exercises in addition to balance exercises on balance, quality of life, lower extremity muscle strength and functional level in adult hemophilic patients.

The aim of this study is to investigate the effects of core stabilization exercises in addition to balance exercises on balance, quality of life, lower extremity muscle strength and functional level in adult hemophilic patients.

Eligibility Criteria:
Inclusion Criteria:

* Hemophilia Patients

Exclusion Criteria:

* Acute Bleeding
Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment

This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG).

Participants with undiagnosed neuromuscular symptoms will be targeted via social media paid advertisements to recruit them to our study landing page (weblink: https://bit.ly/unearthrootcause). Two assessment tools were developed by the study team: the Impact of Daily Living (IDL) Survey and the MG Exercise Assessment. Both tools were designed using supporting literature, accepted guidelines, and a rigorous review via a panel of practicing neurologist key opinion leaders experienced in treating MG patients.

Adult participants who don't have specific diagnosed neurologic conditions will first be screened for eligibility based on the results of the IDL survey which will query participants on the presence or absence of habits/symptoms characteristic of MG. Those who qualify will complete the MG Exercise Assessment in which participants are provided video instructions to perform a series of 10 physical tests to examine if specific muscle groups undergo inducible fatigue. The results of the MG Exercise Assessment are reviewed by a neurologist to determine if participants would benefit further from an in-person neurologist evaluation for MG by a provider. Each participant is provided with a report of the neurologist's evaluation. Participants will be followed for 1 year through bimonthly communications to determine if and when they followed up with a clinician and if they received a confirmed diagnosis of myasthenia gravis.

Eligibility Criteria:
Inclusion Criteria:

* Reside within the 50 states of the United States at the time of enrollment
* Age 19 or older if reside in Nebraska or Alabama, Age 21 or older if reside in Mississippi, Age 18 years or older if reside in any other state
* Active email account
* Fluency in English (spoken / written), as demonstrated by the ability to read and sign the Informed Consent Form

Exclusion Criteria:

* Live in an overseas territory of the United States
* Inability or unwillingness to provide written informed consent
* Diagnosed myasthenia gravis
* Diagnosed multiple sclerosis
* Have speech impairment, eye/arm/leg weakness due to diagnosed brain cancer, or stroke
A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis

This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age
* rheumatoid arthritis (RA) of \>6 months duration
* able to receive outpatient treatment
* on methotrexate for at least 12 weeks before entering study, at a stable dose of 7.5-25 mg/week for the last 8 weeks
* oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) permitted, if at a stable dose for 4 weeks before study start

Exclusion Criteria

* major surgery (including joint surgery) within 8 weeks prior to screening, or planned surgery within 6 months after entering study
* history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA
* inadequate response to anti-tumor necrosis factor (TNF) agent during the 6 months prior to baseline, or inadequate response to \>2 anti-TNF agents
* initiation of treatment with lipid lowering agents within 12 weeks prior to baseline
Effects of Single Oral Dose Dapagliflozin QT Study

The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males


Eligibility Criteria:
Inclusion Criteria:

* Healthy males age 18 to 45 years of age, who are not currently taking any medications
* Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)

Exclusion Criteria:

* No personal or family history of significant heart problems
* No use of over the counter medications within 7 days of the study
* No use of prescription medicaiton within 1 month of the study
Smoking by IV Pulsed Nicotine

To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.

Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, participants will be tested under 5 conditions: 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). The main outcome measures will be self-report drug effects and urges to smoke cigarettes.

The investigators hypothesize that the abuse potential and alleviation of smoking urges are produced by nicotine as a function of nicotine dose and delivery rate.

This study is complete with 13 enrolled and 10 completers

Eligibility Criteria:
Inclusion Criteria:

* Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year
* smoke ≥ 5 and less than 20 cigarettes per day
* urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker
* not seeking treatment at the time of the study for nicotine dependence
* in good health as verified by medical history, screening examination, and screening laboratory tests; and 6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
* regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
* current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
* use of e-cigarettes more than 10 days in the past 30 days
* urine drug screening indicating recent illicit drugs use (with the exception of marijuana)
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection

The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection.

All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective


Eligibility Criteria:
Inclusion Criteria:

* Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2.
* Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

* History of SARS-CoV-2 infection in the past 6 months
* Experiencing measured fever (documented temperature \>38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19
* Known medical history of active liver disease
* Chronic Kidney Disease or have known moderate to severe renal impairment.
* Known Human Immunodeficiency Virus (HIV) infection with viral load \> 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment
* Suspected or confirmed concurrent active systemic infection
* Active cancer requiring treatment with prohibited medication.
* Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
* Has received approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening
* Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38.
* Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
* Known or prior participation in this trial or another trial involving PF-07321332.
* Females who are pregnant or breastfeeding.
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)

To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects (aged 19\~45 years at the time of screening)
* Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1～25.8 (inclusive of limits).
* Subjects with a fasting plasma glucose (FPG) of 70～110mg/dL (inclusive of limits) at the time of screening
* Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.

Exclusion Criteria:

* Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.
* Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.
* Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS

Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.

Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The sample to be included will be 90 patients, 45 per group.

Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. Although there are other factors, the main cause of postoperative genitourinary dysfunction is intraoperative injury of the autonomic pelvic nerves. One of the regions with more risk is the Inferior Mesenteric Artery (IMA). The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.

Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, pre and postoperative quality of life. The sample to be included will be 90 patients, 45 per group.

Eligibility Criteria:
Inclusion Criteria:

* Males;
* Age greater (or equal) to 18 years
* Diagnosed of rectal adenocarcinoma at ≤ 15 cm from the anal margin (by rigid rectoscopy)
* Candidate for neoadjuvant (chemoradiotherapy).
* Scheduled laparoscopic radical TME surgery carried out by colorectal surgeons;
* ASA I, II or III;
* Informed consent present.

Exclusion Criteria:

* women
* Under 18 years old;
* Not Candidate for neoadjuvant (chemoradiotherapy);
* Emergency surgery;
* Recurrent neoplasms
* cT4
* Patient with a history of infra-abdominal, or pelvic surgery of the prostate, or radiotherapy prior to the current process;
* Patients with severe sexual dysfunction and neurological alterations before surgery
* Patients with neurogenic bladder before surgery.
* Not to sign the informed consent
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).

The study will consist of an estimated 200 subjects with HGD or LGD within BE who are deemed inoperable or refuse standard surgical treatment. A maximum of 20 investigational sites will participate with a maximum of ten subjects per site.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky performance status of 50-100%
* Life expectancy greater than 5 years
* Hematopoietic, Hepatic and Renal lab clearance
* Previous endoscopy with histological confirmation of LGD or HGD within BE
* For Group 2, deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough unbiased discussion of surgery.
* For Group 2, endoscopic ultrasound (EUS) evaluation demonstrating no evidence of invasion or metastatic lymph node involvement (T0N0M0 by EUS).

Exclusion Criteria:

* Pregnant, not practicing adequate contraception, intending to become pregnant, or lactating at any time during the study (approximately 2 years).
* Esophageal stricture preventing passage of endoscope or catheter.
* Active esophagitis
* EMR performed less than 8 weeks prior to CSA treatment.
* EMR performed on greater than 90% circumference of any area of the esophagus.
* Any previous esophageal surgery, except fundoplication without complications.
* Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
* Concurrent enrollment in an investigational drug or device trial that clinically interferes with the LCS Dysplasia endpoints.
* Psychiatric or other illness deemed by the investigator as an inability to comply with this protocol.
* Medically unfit or other contraindication to tolerate upper endoscopy.
* Inability to tolerate therapy with a proton pump inhibitor (PPI).
* Refusal or inability to give consent.
* Other active malignancy (except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free).
* Concurrent chemotherapy.
* Prior radiation therapy which involved the esophagus.
* Prior adenocarcinoma involving the esophagus or stomach.
* Prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc.
Assessment of the Impact of COVID-19 Pandemic on Residents Training and Mental Health in Poland

The aim of study is to investigate the impact of SARS-CoV-2 on ophthalmology training programs among residents. To the best of our knowledge this study is the first of its kind in Poland. The impact of COVID-19 on ophthalmology training programs is largely unknown as there are only few studies assessing the above issue from the resident's point of view.

The novel coronavirus SARS-CoV-2, responsible for Coronavirus Disease 2019 (COVID-19), was first identified at the end of the year 2019 in Wuhan (China). A rapid spread of the disease resulted in global threat to public health. On 11 March 2020 the World Health Organization (WHO) announced the state of pandemic. In Poland, the first confirmed case of COVID-19 was reported on 4 March 2020 and subsequent growing number of patients has placed tremendous strain on healthcare system. The crisis situation prompted immediate action to divert healthcare resources for the treatment of patients with COVID-19 and to limit the spread of the infection. In accordance with the decision of the Minister of Health of March 13th, 2020, more than twenty hospitals were established to admit only the SARS-CoV-2 affected patients. Moreover, all hospitals were recommended to limit their planned activity and to perform only urgent and emergency services.

The investigators hypothesize that those changes in healthcare system and restrictions established in public area during pandemic caused significant difficulties in residency training considering clinical and surgical practice as well as didactic activities. In spite of gradual reopening the routine services over the last few months, social distancing rules are still in force. Accordingly, different methods of virtual teaching were introduced including, inter alia, organisation of courses, lectures and conferences in form of on-line meetings.

The aim of current study is to investigate the impact of SARS-CoV-2 on ophthalmology training programs among residents. To the best of our knowledge this study is the first of its kind in Poland. The impact of COVID-19 on ophthalmology training programs is largely unknown as there are only few studies assessing the above issue from the resident's point of view.

The investigators believe that this investigations will address this gap in the literature and could be used to initiate the new solutions in order to maintain successful residency training during pandemic. Opinions regarding the efficiency of e-learning methods and on-line meetings may be crucial to innovate the conventional teaching way permanently in the future.

Eligibility Criteria:
Inclusion Criteria:

* male and female in the age of 25-35 during residence training

Exclusion Criteria:

* lack of consent for participating in survey
Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)

The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle transposition (adiFLAP) for the improvement of cardiac function in patients with a chronic myocardial infarct. Preclinical studies in the porcine model of myocardial infarction have shown that AdiFLAP reduces infarct area.

This novel intervention consists of the pericardial isolation of adipose tissue maintaining its vascularization to create an adipose flap (adiFLAP) and its transposition fully covering infarcted myocardium.

Eligibility Criteria:
Inclusion Criteria:

* Established transmural myocardial infarction non candidate to revascularization (\>3 months-old)
* Candidate to coronary by-pass for other territories different from the previous transmural infarct.
* \> 18 years of age, male or female, capable of giving an informed consent.

Exclusion Criteria:

* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
* Severe valvular disease candidate for surgical restoration.
* Candidate to ventricular remodeling.
* Contraindication for NMR (creatinin clearance \<30 ml/min/1.73m2, metallic implants, claustrophobia).
* Severe renal or hepatic failure.
* Abnormal laboratory tests (no explanation at the time of inclusion).
* Previous cardiac intervention.
* High surgical risk (Euroscore 2).
* Pregnant or breast feeding women.