cyrilzakka/clinical-trials huggingface dataset:
Validation of a New Method to Measure Cardiac Output: Comparison With Thermodilution

Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among them the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous pulmonary ThD in measuring CO in hemodynamically unstable patients.

Hemodynamic monitoring is important in critically ill patients. It is often used to assess a cardiovascular derangements, to help diagnosing the causes and to monitor the response to therapy.

Pulmonary thermodilution (ThD) is still considered the gold standard reference method for cardiac output (CO) measurement \[1\]. Its invasiveness, however, often limits or delays its application \[2, 3\]. In the last decades new less invasive hemodynamic monitoring systems have been developed. The majority of such new devices allows for continuous monitoring of CO and other hemodynamic variables \[4\].

Among the various less invasive techniques, the PiCCO (Pulse-induced Contour Cardiac Output) relies on the concept of the "pulse contour methodology" for providing beat-to-beat CO assessment. This method needs transpulmonary ThD calibration. This is a well validated dilution technique \[5\]. Another minimally invasive system is the Pressure Recording Analytical Method (PRAM). Unlike other systems with pulse contour analysis, the PRAM does not need external or internal calibration factors since it analyzes the pressure waveform at a frequency of 1000 Hz and computes the patient's cardiovascular system impedance using a mathematical algorithm based on the physical theory of perturbations. It only requires a connection to a femoral or radial artery catheter for the acquisition and analysis of the arterial pressure traces \[6\]. This new method has been validated under different experimental and clinical settings \[6-9\]. Limited data are available under conditions of hemodynamic instability \[10-12\]. So far, its accuracy and reliability in assessing CO in hemodynamically unstable patients needs yet to be clarified.

Eligibility Criteria:
Inclusion Criteria:

Hemodynamic instability in:

* septic shock
* pneumonia
* polytrauma
* chronic obstructive pulmonary disease
* heart failure
* post operative cardiosurgical patients

Exclusion Criteria:

* Atrial fibrillation
* Pacemaker or implantable cardiac defibrillator
* Aortic or mitral valve disease
* Intra-aortic balloon pump
CommunityRx-Dementia

Caregivers of home-dwelling people with Alzheimer's Disease and related dementias (ADRD) are one of the most rapidly growing populations in the United States. Among ADRD caregivers with unmet health-related social needs, this study aims to evaluate the effects of the CRx-D intervention versus usual care on caregiver self-efficacy.

The CRx-D intervention is a caregiver-centered adaptation of CommunityRx (CRx), an information-based intervention that systematically matches people to nearby community resources for health-related social needs. We are conducting a single-blind randomized controlled trial and enrolling caregivers through UChicago-affiliated clinic sites. Caregivers will be screened and asked about unmet health-related social needs at the outpatient visit. Eligible, self-identified caregivers will complete an in-person baseline survey on-site (face to face), followed by phone surveys at 7, 30, 90 days, and 12 months. Caregivers randomized to the intervention will receive tailored information on community resources for their identified health-related social needs. They will also be given access to an online community-resource tool and shown how to use it, so they can search for additional resources in their community beyond the point-of-care and outside of the clinic. All caregivers (regardless of research arm) will also receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.

The anticipated sample (n=414) includes pretest participants (n=20), RCT participants enrolled in the 12-month RCT (n=344) and additional men caregivers enrolled in a 3-month RCT (N=50).

Eligibility Criteria:
Inclusion Criteria:

* Resides in the target geographic region of the study (living in 1 of the 35 target zip codes)
* Self-identifies as a caregiver of a home-dwelling person with Alzheimer's Disease or related dementia using an adaptation of the BRFSS caregiver module
* Has access to a cell phone and provides the research interviewer with the cell phone number
* Agrees to receive text messages from the study
* Has a personal email address.
* Self-report their gender identity to be male or trans male/trans man (only for additional 50 caregivers enrolled in the 3-month RCT)

Exclusion Criteria:

* Past enrollment in the CommunityRx-C study
* Recollection of previous receipt of a HealtheRx
The Efficacy of Laser Assisted Hair Removal in the Treatment of Acne Keloidalis Nuchae; a Pilot Study

Laser causes elimination and miniaturization of hair shafts that are the principal contributor to inflammation in Acne Keloidalis Nuchae (AKN).


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from AKN
Study of Single Platelet-Rich Plasma Local Injection Vs. Single Corticosteroid Local Injection in Carpal Tunnel Syndrome

This clinical trial aims to evaluate the effect of a single local platelet-rich plasma injection Versus local steroid injection in treating mild idiopathic carpal tunnel syndrome regarding pain relief and function improvement and electrophysiological studies of the median nerve as a baseline and during a follow-up period of 3 months.

The main question\[s\] it aims to answer are:

* Does platelet-rich plasma injection provide better pain relief for CTS symptoms than steroid injection?
* Does platelet-rich plasma improve parameters of median nerve conduction study than local steroid?

Participants will have:

* A complete history and clinical examination, including sensory and motor examination and provocative tests for CTS.
* Visual analog scale (VAS), Symptom severity scale (SSS), and functional severity scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) before local injection and three months after local injection by the same investigator.
* Nerve conduction studies (NCS) for median and ulnar nerves were carried out before local injection and three months after local injection by the same investigator.

Researchers will compare the efficacy of a single PRP local injection compared to a single corticosteroid local injection for treating mild idiopathic CTS using nerve conduction studies (NCS), Visual Analog Scale (VAS), and Boston Carpal Tunnel Questionnaire (BCTQ) as objective and subjective outcome measures.

Carpal tunnel syndrome (CTS) is the most known entrapment neuropathy. Diagnosis of CTS is clinical, which could be confirmed by nerve conduction study (NCS). Non-operative management is the first line of treatment, including splitting, antiinflammatory, and neurotonics.

There is evidence of improvement in CTS after local corticosteroid injection, but complications are still recorded \[5\]. Platelet-rich plasma (PRP) is a novel, promising treatment providing growth factors for nerve regeneration and inflammation relief. This field needs further evaluation and analysis compared to traditional local steroid injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild primary CTS complaining of paresthesia in the palmar aspect of lateral three and half fingers of the hand. They are selected clinically and confirmed according to Padua's Neurophysiologic Severity Scale (PNSS) for CTS

Exclusion Criteria:

* Patients were excluded if they had moderate-to-severe NCS findings, space-occupying lesions within the carpal tunnel, traumatic CTS, pregnancy, diabetes mellitus, rheumatoid arthritis, or previous CTS surgery.
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)

The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%) with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in patients with glaucoma and ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma and ocular hypertension

Exclusion Criteria:

* History of ocular surgery within 3 months
* Administration contradiction to timolol and dorzolamide
Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

Following screening period (up to 28 days in length), a total of 40 subjects are planned to be enrolled into this study from multiple sites in the United States, Australia, New Zealand, and Moldova. Eligible subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) or placebo via a computer-generated interactive web response system (IWRS). Each of the NX-13 treatment groups will comprise 12 subjects and 4 subjects will be randomized to receive placebo. The study will include a maximum of 25% of subjects who have had prior exposure to biologic therapy for UC.

Dosing will extend over a 28-day period at each dose level. Subjects will receive the first dose of study drug in clinic on Day 1 (Visit 2) and Day 28 (Visit 4/EOT) but will self-administer IP at home once daily for the remaining dosing days. The study duration will be approximately 63 days: Screening Period (28 days) + Treatment Period (28 days) + Safety Follow-up (7 days after last dose). There will be a follow-up visit on Day 35 (Visit 5).

Eligibility Criteria:
Key Inclusion Criteria:

* male and female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC ≥ 90 days before screening;
* active UC defined as a total Mayo Score of 4 to 10 (inclusive), at baseline, with a Mayo endoscopic subscore (MES) ≥ 2 confirmed by a central reader;
* baseline fecal calprotectin ≥ 250 μg/g;
* biologic-naïve or having stopped biologic therapy ≥ 8 weeks before the start of the study;
* 5-aminosalicylates must be stable for ≥ 1 month prior to randomization.

Key Exclusion Criteria:

* Crohn's disease (CD), indeterminate colitis, or presence or history of fistula with CD;
* a history of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma;
* history of or at imminent risk of colectomy;
* history of or current colonic dysplasia ;
* recent history (within 2 years prior to randomization) or current adenomatous colonic polyps;
* treatment with an immunosuppressant within 3 months of randomization;
* bacterial or parasitic pathogenic enteric infection;
* live virus vaccination within 1 month prior to screening.
Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants

The purpose of this study is to evaluate enzyme availability in the central nervous system before and after CC-97489 administration in healthy participants


Eligibility Criteria:
Inclusion Criteria:

* Has a Body Mass Index (BMI) of 18.0 to 33.0 kg/m\^2, inclusive. BMI = weight (kg)/(height \[m\])\^2
* Must be healthy based on medical history, physical examination (PE), clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) at screening and check-in

Exclusion Criteria:

* Has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
* Is pregnant or breastfeeding
* Is part of the study site staff personnel or a family member of the study site staff

Other protocol-defined inclusion/exclusion criteria apply
CNS Changes Following Amputation

The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following congenital upper limb loss. The focus is on the brain's sensory processing and how neuronal changes may relate to clinical measures. By doing so, the hope is to gain insight into the contribution of critical periods to the plasticity of the sensorimotor processing stream. Both macroscopic and microscopic changes of the brain will be examined in individuals with upper limb amelia and compared to healthy controls. fMRI will be combined with behavioural testing to understand which clinical and behavioural determinants drive somatosensory representations along the entire somatosensory processing stream. Using advanced imaging techniques, the aim is to investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, gain a better understanding of the mechanistic underpinnings of functional reorganisation. Overall, the hope is to provide the first mechanistic insight into whether early life experiences are crucial for the development of the relay nuclei in the central nervous system and how these changes relate to clinical measures such as adaptive behaviours or pain.


Eligibility Criteria:
Inclusion Criteria - Patients:

* Age 18-75
* Upper-limb congenital amputees with complete absence of a hand
* Signed informed consent

Exclusion Criteria - Patients:

* Contraindications to magnetic resonance imaging
* Neurological impairment of body function impairments not induced by spinal cord injury
* BMI \> 40
* Pregnancy
* Claustrophobia

Inclusion Criteria - Healthy subjects:

* Age 18-75
* Signed Informed consent

Exclusion Criteria - Healthy subjects:

* Contraindications to magnetic resonance imaging
* Pregnancy
* Neurological illness
* Impairment of body function induced by a congenital upper-limb amputation
* Claustrophobia
* BMI \> 40
Vfend Special Investigation For Prophylaxis

Examine the safety and effectiveness of Vfend \[voriconazole\] for prophylaxix use under general clinical practices.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).

Exclusion Criteria:

* Patients who have been previously enrolled in this study.
the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma

A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.

The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.

lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL\< 25.65 umol/L, ALT and AST \< 2 times the upper limit of normal value;

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old, regardless of gender;
2. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;
3. KPS score ≥70;
4. Ccr≥ 50 mL/min, TBIL\< 25.65 umol/L, ALT and AST \< 2 times the upper limit of normal value;
5. ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L；
6. Patients can tolerate chemotherapy；
7. No active infection before chemotherapy;
8. The retrospective enrolled subjects are exempted from informed consent for data collection, and the prospective enrolled subjects voluntarily participate in this experiment and sign the informed consent form;
9. The researcher thinks that the subjects can benefit.

Exclusion Criteria:

1. Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);
2. Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;
3. Subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment;
4. severe mental or nervous system diseases;
5. Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or auxiliary materials of other preparations expressed by Escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions;
6. pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;
7. The researcher judges other subjects who are not suitable to participate.
TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence

The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR\* System (Tension-free Support for Incontinence) in women with stress urinary incontinence (SUI).

The primary variable for effectiveness is \> 50% improvement on the subjective symptom Visual Analog Scale (VAS) at Visit 3/Week 5 (35 days post-surgery) to be accepted.

Eligibility Criteria:
Inclusion Criteria:

* Must be female with objective, demonstratable signs of SUI or stress predominant mixed incontinence and requires elective, primary surgical intervention.
* Must be at least 21 years old.
* Must be postmenopausal (amenorrhea) for at least 1 year or surgically sterile (bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of pregnancy) or has a negative pregnancy test prior to study entry and has decided to cease childbearing.
* Agrees to participate in the study, including all study related procedures and evaluations and documents this agreement by signing the IRB/EC-approved informed consent

Exclusion Criteria:

* Have any other coexistent pathology requiring concomitant surgery that may impact this procedure i.e. surgeries that involve the anterior vaginal wall (e.g. anterior colporrhaphy, diverticula, anterior Prolift) Any allowable concomitant surgery must be performed prior to the GYNECARE TVT SECUR System surgery.
* Have intrinsic sphincter deficiency (ISD) \[Urethral Pressure Profile (UPP) with a maximum urethral closing pressure (MUCP) \< 20cm H2O or Leak Point Pressure (LPP) \< 60\].
* Have an active urinary tract infection (UTI) or vaginal infection at time of surgery.
* Have a fixed urethra (\< 30° mobility on Q-Tip Straining Test).
* Have had prior incontinence surgery.
* Have a post-void residual volume \> 100mL.
* Have co-existent pelvic organ prolapse that is symptomatic or extends beyond the hymen.
* Have lower urinary tract pathology in the form of a fistula or diverticulum.
* Have a malignancy or with a history of malignancy within the past 5 years, except for a basal cell carcinoma that has been treated with local excision and is no longer present.
* Are on anticoagulant therapy.
* Have received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment.
* Are deemed by the investigator as medically unfit for surgery or who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the GYNECARE TVT SECUR System IFU.
* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.
Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke

The investigators will conduct a single-blind, randomized controlled trial of 60 patients with subacute stroke. Patients will be randomly assigned into a control group and an intervention group. The intervention group will participate in immersion VR training for 3 weeks. The control group will receive for traditional rehabilitation training for 3 weeks. Then, the patients will be reevaluated to determine changes in upper extremity function, cognitive function, cortical and subcortical activation patterns, and performance of activities of daily living after the baseline assessment.


Eligibility Criteria:
Inclusion Criteria:

1. having had an ischemic stroke in the first time
2. age 30 to 80 years old
3. first stroke within 2 month
4. GCS score \>8
5. the upper-limb function BrunnstromⅡ、Ⅲ

Exclusion Criteria:

1. hemorrhage or transient ischemic attack(TIA)
2. important organs such as heart, lung, liver, kidney function decline or failure
3. previous history of brain neurosurgery or epilepsy
4. had severe cognitive impairments or aphasia, which made the participants unable to understand the instructions given by the investigators
5. with claustrophobia and body with metal (such as metal teeth, etc.) are not suitable for to MRI scanning
Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis (OA) of the knee for \>6 months
* moderate to severe pain immediately following a 50-foot walk
* knee pain primarily due to tibiofemoral OA and not from patellofemoral OA
* bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee
* willing and able to participate in regular exercise for four months
* free from musculoskeletal limitations that would preclude resistance exercise participation
* free of abnormal cardiovascular responses during the screening graded maximal walk test

Exclusion Criteria:

* unable to walk
* regular resistance exercise training (\>3X week) within the past 6 months
* specific low back pain or acute back injury
* spinal stenosis that precludes walking one block due to neurogenic claudication
* any major injury to either knee within the prior 12 months
* any surgery to either knee within the last 12 months
* lumbar radiculopathy
* vascular claudication
* significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee
* have had corticosteroid or viscosupplement injections within three months of study participation
* have added new over the counter or prescription pain medication within two months of study participation
The Effect of Laser-assisted Zona Thinning on the Implantation Rate in the Women of Advanced Age

The purpose of this study is to determine whether laser-assisted zona thinning improve the implantation rate of the women of advanced age in the first IVF/ICSI cycles

Registry procedures：

1. It's required to sign an informed consent form prior to the recruitment of all patients.
2. Data collection and entry need double check and supervision.

The outcome measures:

the implantation rate per embryo transfer miscarriage live birth

Eligibility Criteria:
Inclusion Criteria:

* Age: 35y ≤age≤46y
* Basal FSH value: FSH≤10IU/L
* Day-3 embryos transferred in the fresh IVF/ICSI cycles
* the number of embryos available to be transferred on Day-3: ≥one embryo

Exclusion Criteria:

* cycles with thawed/warmed embryos biopsied for PGD/PGS.
* cycles with oocyte donation transfer.
* the maximum number of previous unsuccessful IVF attempts: ≥ 3 cycles(transfer cycles)
* any cycles with the risk of OHSS, fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation, and other acute maternal problems.
* One or both spouses have an abnormal karyotype (including polymorphism)