cyrilzakka/clinical-trials huggingface dataset:
A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19

This is a dose-finding, inferentially seamless Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314 in Ambulatory Patients with COVID-19.

Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 32 ambulatory adult patients with COVID-19. This phase of the study is designed to assess the safety, tolerability, PK, and PD of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 208 ambulatory adult patients with COVID-19. This phase of the study is designed to assess the efficacy and safety of IBI314, administered by single IV infusion at dose levels that meet none of the termination criteria for dose escalation in Phase 1 of the study.

Eligibility Criteria:
Main Inclusion Criteria:

1. First onset of COVID-19 symptoms \<7 days at randomization, symptoms such as fever and/or chills, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.
2. Have a positive SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test using an appropriate sample such as nasopharyngeal (NP), nasal, oropharyngeal, or saliva within 72 hours prior to randomization. A historical record of a positive result from a test conducted ≤72 hours prior to randomization is acceptable.
3. Male or female patients ≥18 years of age at the time of signing informed consent.
4. Agree to use an adequate method of contraception throughout the study period and for 90 days after the dose of study drug is administered.
5. Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test at screening.

Main Exclusion Criteria:

1. according to protocol v3.0, Note: Patients with mild-to-moderate disease who are placed in a facility where required by local guidelines can be enrolled.
2. Have oxygen saturation (SpO2) ≤93 % on room air at sea level or a ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) \<300, respiratory rate ≥30 per minute, heart rate ≥125 per minute.
3. Have evidence of multi-organ dysfunction/failure.
4. Systolic blood pressure \<90 mmHg, diastolic blood pressure \<60 mmHg, or requiring vasopressors.
5. Require or anticipated impending need for endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
Symptomatic Treatment of Acute Uncomplicated Diverticulitis

The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.


Eligibility Criteria:
Inclusion Criteria:

* Computed tomography-diagnosed acute uncomplicated\* diverticulitis

  * No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.

Exclusion Criteria:

* Already commenced antimicrobial medication
* Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)
* Suspicion of generalized peritonitis
* Organ dysfunction
* Another infection requiring antimicrobial medication
* Pregnancy
* Age \< 18 years or \> 90 years
* Missing written consent
Connectomics in Psychiatric Classification

Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with dementia.

This study extends the assessment of brain connectivity and function, being conducted in the Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has made significant improvements in MRI instrumentation, data acquisition, preprocessing, and analysis. These improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on individuals aged 45-85 years who have a diagnosis of dementia, or are healthy controls. Additionally, similar to the HCP, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.

Eligibility Criteria:
Inclusion Criteria:

* Ages 45-85
* Has consented to participate or has an LAR present that has consented to participate
* DSM-5 diagnosis of Dementia

Exclusion Criteria:

* Any genetic disorder, such as cystic fibrosis or sickle cell disease
* Multiple Sclerosis
* Cerebral Palsy
* Loss of consciousness for \>30 minutes
* Pregnancy
* Hospitalization for stroke, brain aneurysm, brain hemorrhage, or subdural hematoma
Measurement of Antioxidant Activity and Oxidative Stress in Patients Undergoing Ophthalmic Surgery.

This trial hypothesized that novel laser refractive surgery techniques (LASIK, KLEx) or laser-assisted cataract surgery (FLACAS) could suppress postoperative inflammation and improve recovery in patients by reducing oxidative stress generated by the surgical procedure. It is also intended to verify whether the new laser technology is necessary for clinical use in groups with low antioxidant activity through the detection of antioxidant activity in the eyes of patients.

Simultaneously measure total reactive oxygen species (ROS), antioxidant capacity (TAC) and ascorbic acid (AA) in aqueous humor (cataract surgery only) or tears. All patients underwent the same examination at our institution, including uncorrected visual acuity (UCVA), intraocular pressure (IOP), as well as central corneal thickness (CCT) with pneumatic tonometer, apparent refraction with autorefractor, and corneal curvature with keratometer. The axial length (AXL), anterior chamber depth (ACD) and lens thickness (LT) were measured by optical biometer.

Eligibility Criteria:
Inclusion Criteria:

* at least 20 years old
* corneal refractive surgery or cataract surgery patients

Exclusion Criteria:

* patients with eye infections
* presence of severe retinal disease
* presence of severe eye injury or severe ptosis
Evaluation of the Mechanisms of Weight-bearing of the Hemiplegic Limb During Table Tennis Sessions in the Framework of Post-stroke Rehabilitation : Pilot Study

This is an experimental, observational, prospective study designed to develop medical knowledge.

The primary objective of the study is to analyze the weight bearing of the hemiplegic side according to the different areas of interest during the practice of table tennis.

This study is part of a usual framework of management of post-stroke hemiplegic patients with an additional passage to the movement laboratory to collect additional data collection, via the use of force plateforms, considered here as non-interventional.

The passage to the movement laboratory consists in the practice of a table tennis session including three game situations. Before to the table tennis session, the subject placed on the force plateforms, performs a spontaneous bipodal station followed by a maximum voluntary support transfer on the hemiplegic limb. During the table tennis session, the subject is filmed and his load on the hemiplegic side during the game situations is evaluated using the force platforms.

In addition of the table tennis session three questionnaires are administered to the patient in order to know :

* The static and dynamic balance in order to identify persons at risk of falling: Berg Balance and Evaluation Scale
* The degree of autonomy of the patient: Modified Rankin Score
* The Stroke severity: NIHSS score


Eligibility Criteria:
Inclusion Criteria:

* Patients treated at the Hopale Foundation for a stroke rehabilitation program
* Patients following the balance and coordination protocol - Minimum age of 18 years
* BERG score \>40
* Subject has played table tennis at least once prior to the stroke.
* Patient is a member or beneficiary of a social security plan.
* Patient who has received informed information about the study and has given his/her consent
* Ability to understand French instructions.

Exclusion Criteria:

* Cognitive disorders notified in the medical file
* Subject under judicial protection :

  * Subject under guardianship
  * Subject under curatorship
  * Subject under protective measure
* Pregnant or breastfeeding woman
* Patient with cognitive disorders preventing the comprehension of instructions
Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome

Patients with the MELAS syndrome experience devastating mental impairment. This study will evaluate the effectiveness of the drug dichloroacetate (DCA) to reduce the symptoms of MELAS.

Although many organ systems are affected by mitochondrial (mt) DNA point mutations, the nervous system is particularly vulnerable. Maternally inherited mtDNA point mutations may cause chronic progressive encephalopathies and mental retardation. Patients with MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes) syndrome have the A3243G point mutation and elevated brain lactate levels. Research has shown that lactic acidosis is associated with progressive impairment in patients with MELAS. This study will evaluate the effectiveness of DCA in lowering lactate levels and slowing the progression of MELAS.

Patients with the A3243G mitochondrial mutation and who have had either a stroke or a seizure will be enrolled in this study. Patients will be randomized to receive either DCA or a placebo. At a predetermined time point, patients receiving DCA will be switched to placebo and patients receiving placebo will be switched to DCA. Patients will have study visits every 3 months for 3 years. Study visits will include neurological exams, cognitive testing, nerve conduction tests, and MRIs. Study medicine, testing, hospitalization for research purposes, and travel expenses will be fully covered by the study.

Eligibility Criteria:
Inclusion Criteria

* A3243G mtDNA point mutation or maternally related to someone who has the mutation
* Symptomatic with MELAS, including previous seizure or stroke
* Certain laboratory values
* Ability to comply with the study protocol
Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With COPD

It is still not clearly known whether doing the walk test in a course is different from doing it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in this study, we will have an alternative for this test in places where there is not enough room, benefiting the assessment of COPD patients' functional capacity. In the literature, there are still some controversies about performing the test on a treadmill or in a corridor and whether there is interference with the distance walked. Our hypothesis is that there is no interference with the distance walked, and thus we have one more option to perform the test in case there is no 10-meter corridor available.

Spirometry tests will be performed using ULTIMA CPX equipment. Volunteers will perform the tests twice, on different days (see protocol description), in a corridor and on a treadmill, until reaching their limit of tolerance. In the test performed on the treadmill and in the one performed in the corridor, subjects will simultaneously use the VO 2000. And the volunteers will fill out the Saint George's Respiratory Questionnaire (SGRQ).

Eligibility Criteria:
Inclusion Criteria:

* clinically stable
* not dependent on oxygen to exercise
* diagnosis of COPD according to the GOLD

Exclusion Criteria:

* cognitive deficit or musculoskeletal
* in process of exacerbation
* have performed pulmonary rehabilitation
Focus Group in Collecting Feedbacks From Indoor Tanning Bed Users for Social Media-Delivered Intervention Development

This research trial collects feedbacks from indoor tanning bed users via focus group for the development of social media-delivered intervention. Conducting a focus group with people using indoor tanning bed and having access to Facebook may help doctors to better understand people's perspective and thoughts about the various Facebook messages.

PRIMARY OBJECTIVES:

I. To elicit feedback from young adult women who use indoor tanning beds on preliminary intervention content.

OUTLINE:

Participants attend a focus group session and review printed copies of planned posts for the to-be-developed Facebook intervention over 90 minutes to 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Use of an indoor tanning bed at least 10 times in the past 12 months
* At least daily use of Facebook
Prognostic Impact of Adjuvant Therapy in Primary Hepatic Sarcomatoid Carcinoma

In recent years, researchers have conducted extensive studies on adjuvant therapy following surgical resection of liver cancer, exploring its potential benefits and seeking effective treatment strategies. Given the rarity and high aggressiveness of primary hepatic sarcomatoid carcinoma, there is a lack of reliable clinical evidence on whether postoperative adjuvant therapy can benefit patients, resulting in the absence of established standard guidelines. Therefore, we conducted a single-center retrospective study to assess the potential benefits of postoperative adjuvant therapy for patients of primary hepatic sarcomatoid carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. patients who underwent liver resection
2. patients' postoperative paraffin pathology and immunohistochemistry results were reviewed to identify those diagnosed with PHSC

Exclusion Criteria:

1. patients who received other anti-tumor treatments before surgery, such as radiofrequency ablation (RFA), transarterial chemoembolization (TACE), radiation therapy (RT), and systemic therapy;
2. patients diagnosed with other specific types of sarcomas;
3. patients with concurrent other malignancies during the course of PHSC;
4. patients who were lost to follow-up or lacked essential clinical data.
A Prospective Patient Registry of Patients Exposed to Bedaquiline

The purpose of this study is to describe the medical indication and utilization of expert medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility based on minimum inhibitory concentrations (MICs) reported for baseline and subsequent isolates, BDQ drug utilization data to include dose, duration, past treatment history, past medical history, concomitant medications, and health care site of treatment, drug distribution mechanisms used in the administration of BDQ, patient outcomes (clinical and microbiologic) and adverse events among BDQ-treated participants, including deaths.

This is a prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group) observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions) study of participants treated with BDQ. Participants will be enrolled by their healthcare provider once the healthcare provider decides to treat with BDQ or after BDQ treatment initiation but prior to observation of any participant outcomes. All participants meeting the inclusion criteria and providing informed consent for participation in the study will be enrolled in this study. The registry enrollment period will be open for 36 months with an additional 24 months BDQ treatment-free follow-up for safety assessment for the last participants enrolled during the 36 months enrollment period. Participants' follow-up data will be collected at each visit from the healthcare provider during the course of BDQ and for an additional 24 months after the last BDQ dose or until the participant is lost to follow-up. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants capable of providing informed consent, which must be obtained prior to collection of any patient outcomes and documented laboratory and clinical variables to meet the study objectives
* Participants who have documented enrollment in the bedaquiline patient registry (BPR) prior to the start of BDQ treatments and documented initiation of BDQ treatment after enrollment
* Participants who have documented initiation of BDQ treatment prior to enrollment and have no documented patient outcomes and documented laboratory and clinical variables to meet the objectives of the study

Exclusion Criteria:

* No specific exclusion criteria will be applied in this study other than those scenarios that follow from the inclusion criteria
Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection

The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6\~10mm).

One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.

With sized polyp from 6mm to less than 10mm, it has been classified by the previous studies as a "small polyp".

Their potential for advanced neoplasia is usually size-dependent, but some recent studies found that, even in diminutive and small polyps, the rate of advanced neoplasia is relatively high about 9%-10%.

The investigators will prospectively investigate postprocedural outcomes, such as retrieval rate, procedural time, overall complication rate (Intraprocedural bleeding, postprocedural bleeding, and perforation) in colonoscopic polypectomy of small polyp between CSP and EMR.

Eligibility Criteria:
Inclusion Criteria:

* All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)

Exclusion Criteria:

* (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.
The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits

This study evaluates the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (BMI \> 40.0) African American women.

Stress has been identified as a major barrier to engaging in healthy lifestyle behaviors (e.g. diet and exercise) among African American women. African American women consistently lose less weight than their Caucasian counterparts in weight loss interventions. One reason for this disparity may be due to the failure of most weight loss interventions to address stress management adequately or in a culturally competent way.

The purpose of this study is to evaluate the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (BMI \> 40.0) African American women. The stress-focused weight loss intervention will incorporate stress management content throughout the entire intervention and will include content that is culturally tailored. The standard weight loss intervention will cover stress management techniques during one of the 14 sessions and the material will be more generic in nature (e.g. not culturally tailored).

Eligibility Criteria:
Inclusion Criteria:

* African American (self-identified)
* Female
* BMI \> 40 kg/m2
* Access to internet connection and phone for personal use

Exclusion Criteria:

* Unable to walk without the use of an assistance device
* Failure to pass the Physical Activity Readiness Questionnaire (PAR-Q) or unable to attain medical clearance from their doctor
* Substance abuse within past two years
* Schizophrenia
* Currently pregnant, pregnant within the past 6 months or plans to become pregnant in the next 6 months
* History of malignancy other than non-melanoma skin cancer, that has not been in remission or cured surgically for \> 5 years
* Participation in a weight loss program in the past 12 months
* \> 5% loss of body weight within the past 6 months
* Bariatric surgery recipient
* Heart attack in the past 6 months
* Stroke within the past 6 months

NOTE: Participants who "fail" the PAR-Q will be required to obtain medical clearance from their medical provider
A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), multicenter, placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), dose range finding study of JNJ-38518168 in patients with active RA despite concomitant MTX therapy. The study will consist a screening period, a 24-week placebo-controlled period and a 4-week follow-up period between the last dose and the last visit. The duration of participation in the study for an individual patient will be up to 34 weeks (including screening). The patients will be assigned to 1 of 4 treatment groups in a 1:1:1:1 ratio to placebo and JNJ-38518168 (3 mg or 10 mg or 30 mg). Safety assessments and evaluations to determine the efficacy of JNJ-38518168 to reduce the signs and symptoms of RA will be performed at study visits. Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Has had rheumatoid arthritis for at least 6 months prior to the date of signing the informed consent at screening
* Must be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening
* Must have active rheumatoid arthritis (at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline and Serum C reactive protein greater than or equal to 0.80 mg/dL at the time of screening
* Has been treated with and tolerated methotrexate treatment at dosages from 10 to 25 mg/week inclusive, for a minimum of 6 months with stable dose for at least 8 weeks prior to the date of signing the informed consent at screening

Exclusion Criteria:

* Has inflammatory diseases other than rheumatoid arthritis, including but not limited to adult onset Still's disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy
* Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled
* Has ever received any approved or investigational biologic agent for a rheumatoid indication
* Has been treated with any nonbiologic disease modifying antirheumatic drugs within 4 weeks prior to the first administration of study agent