cyrilzakka/clinical-trials huggingface dataset:
Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

The purpose of this study is to assess the efficacy and safety of Iguratimod combined with Tofacitinib in the treatment of csDMARD-IR patients with active moderate-to-severe rheumatoid arthritis

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Iguratimod (25mg, twice daily) combined with Tofacitinib (5mg, twice daily) or placebo (25mg, twice daily) combined with Tofacitinib (5mg, twice daily).

Eligibility Criteria:
Inclusion Criteria:

Patients who meet the following inclusion criteria will be eligible to participate in the study:

1. Male or female aged 18-65 years old;
2. Weight not less than 40kg;
3. Since the diagnosis of RA, the course of disease was ≥6 months;
4. Patients who meet RA standards in 1987 and 2010 ;
5. RA patients with moderate to high disease activity (DAS28 \> 3.2) at the time of screening;
6. Active RA (≥6 joints swelling \[66 joints count\]; ≥Tenderness of 6 joints \[68 joint counts\]; ESR\>28 mm/h or C-reactive protein (CRP) \>1.0 mg/dL);
7. Poor response or intolerance to at least one DMARD, including csDMARDs, bDMARDs, but not tsDMARDs;
8. Previous use of any JAK inhibitor was discontinued for six months before enrollment;
9. For patients who have used DMARDs, the washout criteria must be met;
10. Written informed consent;

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

* Pregnant or lactating women;
* Platelet count \< 10\^9/L, or white blood cell \< 3\*10\^9/L, or absolute neutrophil count \< 1.2\*10\^9/L, or Hemoglobin \< 9 g/dL or hematocrit \<30%;
* According to Cockcroft-Gault, the glomerular filtration rate was ≤40 ml/min.
* ALT\>1.5×ULN, AST\>1.5×ULN, Cr\>135umol/L;
* Subjects with serious cardiovascular, renal, hematologic or endocrine diseases;
* A history of autoimmune rheumatic diseases other than Sjogren's syndrome;
* Subjects with uncontrolled infection;
* Subjects receiving live vaccines within 6 weeks prior to study entry;
* history of alcohol or drug abuse and abstinence for less than 6 months prior to the first use of the study drug;
* Subjects participating in other clinical study within 3 months prior to study entry;
* Have a history of malignant tumor;
* History of recurrent herpes zoster, diffuse herpes zoster;
* People who are allergic to any of the study drugs;
* Other conditions in which the investigator deemed the patient inappropriate for trial entry;
Virtual Dignity Therapy for Palliative Care Patients with Advanced Cancer

The purpose of this study is to determine if it is feasible and acceptable to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer.

This study is an investigator-initiated, single site Mayo Clinic Rochester prospective minimal risk pilot study to determine feasibility and acceptability of Virtual Dignity Therapy. The Dignity Therapy intervention is a brief, individualized psychotherapy that aims to relieve psycho-emotional and existential distress and improve the experiences of patients whose lives are impacted by serious illness. This therapy offers patients an opportunity to reflect on their life with a trained facilitator and share their thoughts and memories with family and other people in their life. This therapy consists of a total of 3 sessions, with each session 2-4 weeks apart, in which the investigator provides questions focused on life review. The sessions are recorded and transcribed. The interventionist will work with patients to edit the document and provide a final generativity document for patient to keep and give to loved ones.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* English fluency
* No diagnosed dementia
* Diagnosis of advanced cancer
* Expected prognosis \> 6 months
* Provide informed consent
* Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

* Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
* Recent suicide attempt or psychiatric illness severe enough that hospitalization has been necessary in last 6 months
* Active delirium
* Participation in concurrent legacy offerings through the palliative care clinic

Inclusion Criteria for caregivers:

* Age ≥18 years
* English fluency
* Provide informed consent
* Supported patient through Dignity Therapy
The Effect of NHE and KT on the Hamstring Strength and Sprint Performance in Collegiate Sprinters

The invesitgators performed a randomized controlled trial on collegiate sprinters to explore the combined effect of the NHE and KT and randomly allocated the subjects into the experimental (NHE+KT) or control (NHE) group by an independent researcher using the sealed envelopes method.

To calculate the sample size, a Cohen's d effect size of 0.4, an alpha level of 0.05, a test power of 0.95 were configured to G\*Power software, at least 34 samples were computed. Considering the dropouts, 40 male collegiate sprinters were enrolled, explained the procedures of this study and voluntarily written informed consent. Inclusion criteria was that participants must be male, aged 18 years or older, training at the university level at least 4 times per week, with no history of lower limb injury within the last 6 months and no previous experience of the NHE or KT. Participants who had lower limb mobility limitation or injury especially HSI within 6 months and associated musculoskeletal, respiratory or cardiovascular diseases and was allergic to kinesio tape were excluded.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be male, aged 18 years or older, training at the university level at least 4 times per week, with no history of lower limb injury within the last 6 months and no previous experience of the NHE or KT.

Exclusion Criteria:

* Participants who had lower limb mobility limitation or injury especially HSI within 6 months and associated musculoskeletal, respiratory or cardiovascular diseases and was allergic to kinesio tape were excluded.
Activity Monitoring in Frail Elderly Patients

The purpose of this stuydy is to assess the bias and repeatability of the DynaPort MicroMod in measuring movement / physical activity in frail elderly.

Elderly subjects will be recruited from a residential-care complex in Zwolle, the Netherlands. All subjects will be asked to fill in the Groningen Frailty Index. We aim to select patients with varying GFI scores to ensure that we include patients with different degrees of frailty. The participating subjects will be asked to wear the DynaPort MicroMod during six hours. Two research employees will observe all activities of the participating subjects in their home environment. The participant will be instructed to act like it is a normal/usual day. Every 5 minutes the type of activity at that moment and movement intensity of the last 5 minutes (METs scale) is manually entered onto a case report form (CRF) by the two employees. The timing has to be exact in order to compare the data to the data of the DynaPort MicroMod. Type of activity is described as well as categorised into lying, sitting, standing or walking. Movement intensity is categorised according to a MET-value (Metabolic Equivalent of Task).

Sensitivity, specificity, and percentage of overall agreement will be calculated for each type of activity (standing, sitting, lying, walking) and for intensity. The primary analysis will be the comparison between walking and not walking (lying, sitting or standing). An overall agreement/sensitivity/specificity of 90% or higher is considered as sufficient agreement. The Bland and Altman method will also be used as multiple observations are recorded per patient, the limits of agreement will also be calculated with the Bland and Altman method for repeated measures.

Eligibility Criteria:
Inclusion Criteria:

* Age: 75 years and older
* Frailty: GFI (Groningen Frailty Index) score ≥ 4

Exclusion Criteria:

* Living in a nursing-home
Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation

The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome among patients with pharmacoresistant epilepsy.

In recent years it has been shown that many different brain stimulation techniques are effective in seizure reduction in epilepsy patients as well as in animal models of epilepsy. VNS is the method most often used with at least 45.000 patients implanted with this device worldwide. However, prediction of seizure outcome after VNS implantation is not possible in an individual patient so far. Recently, tDCS is increasingly used as a method to reduce seizure frequency in epileptic patients. Therefore it is hypothesized, that a positive effect after a single tDCS, in terms of short time seizure reduction and reduction of epileptic discharges in the EEG, could be predictive for epilepsy outcome after VNS implantation.

In the proposed multicenter prognostic study we test the predictive value of tDCS for each patient with refractory epilepsy 1 week up to 2 months before VNS implantation. The effects of tDCS will be verified via a 15 minutes long routine EEG examination, performed immediately before and after tDCS, together with seizure diary and seizure severity scale, assessed 1 month before and 1 week after tDCS. A 6 months long observation period will follow the VNS implantation. At the end of the 6 months period seizure diary and seizure severity scale of the last month will be performed to measure VNS therapy outcome. On the basis of the described variables, immediate up to 1 week long tDCS effects will be correlated to 6 months long VNS therapy outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age: 12 years and above
* At least 2 years disease history
* Refractory epilepsy:

  * Seizures are not completely responsive to longlasting antiepileptic treatment. At least 4 antiepileptic medicaments failed in mono or combined anticonvulsive regimen.
  * At least 4 seizures per week in the last month, despite adequate antiepileptic regimen.
  * Epilepsy surgery is not indicated or not accepted by the patient or by the parents of the patient.
* A stable anticonvulsive regimen, defined as unchanged dose and type of the antiepileptic medication in the last month before tDCS and before VNS implantation.
* Seizure diary is available and completed.
* VNS implantation is planned within the next 2 months.

Exclusion Criteria:

* Acute, symptomatic seizures (caused by tumor, stroke, acute encephalitis)
* Uncontrolled medical problems (e.g. cardiovascular, nephrotic oder severe, chronic or severe acute disease)
* Increased intracranial pressure for whatever reason
* Implantation of metallic material (e.g. pacemaker, cochlear-implant)
* Diseased or damaged skin over the scalp (e.g. Dermatitis)
* Pregnancy
* Known or supposed non-compliance
* Age: less than 12 years
PRO for Fighting FT in Ovarian Cancer

Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for OC patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.

PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT.The primary aim of the study is to compare PROFFIT financial score (items 1-7 measuring the financial distress) across different lines of treatment for OC patients undergoing anticancer medical treatment. Primary comparison will be based on PROFFIT questionnaire fulfilled at baseline, before starting each line of treatment.

In addition, among secondary aims of this study, we aim to verify whether FT is associated with quality of life response (items 29-30 of the EORTC QLQ-C30 questionnaire and items 55-56 of the EORTC QLQ-OV28 questionnaire), with patient-self reporting toxicity of treatments (selected symptoms of the PRO-CTCAE library response), and with overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided;
* Women ≥18 years;
* Histologically or citologically confirmed diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer stage IC-IV according to FIGO staging system;
* Patients who are close to begin any type of medical treatment against ovarian cancer.

Exclusion Criteria:

* Major cognitive dysfunction or psychiatric disorders;
* Patients with epithelial ovarian, fallopian tube or peritoneal cancer candidate exclusively to follow-up;
* Patients who have received more than 4 previous lines of medical treatment (maintenance treatments do not represent a line).
Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections

Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy.

The investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for treatment of their infection. Additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). The main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter and expected to continue hemodialysis for 3 months will be eligible for enrollment.

Exclusion Criteria:

* The following patients will be excluded from study entry:

  1. patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent and
  2. patient is allergic to NAC, tigecycline, minocycline, or heparin.

The following patients will be excluded from randomization:

1. patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors,
2. patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema,
3. patient is pregnant or will become pregnant,
4. the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.
Simplified Versus Conventional Complete Dentures

The purpose of this randomized, double-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures fabricated using the conventional and simplified techniques.

40 completely edentulous patients, aged 40-85 years, with no relevant medical conditions, seeking complete dentures at a university hospital were included in this study. Those were randomly divided into two groups (n=20). Each group received two sets of dentures, the Group (S) were given the dentures constructed using the simplified technique first while the Group (C) received the dentures constructed using the conventional technique. After 1 month of the first set of dentures delivery, participants were asked to rate their general satisfaction on a 10-cm visual analogue scale in addition to their satisfaction regarding comfort, retention, stability, efficiency of mastication and speaking. Participants were also asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT). Thereafter, each group of patients were given the set of dentures constructed using the other technique, given instructions and recalled after 1 month to evaluate the alternate set of dentures. 2 Prosthodontists performed all the clinical procedures and 1 laboratory technician performed the laboratory procedures. The results of the study were analyzed using Wilcoxon-signed rank test at significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria: Inclusion Criteria

1. Patients seeking new conventional complete dentures for first time or as replacement of their previous complete dentures
2. Patients aged 40-85 y.
3. Patients who had been completely edentulous for at least 6 months
4. Patients who had well developed to moderately resorbed maxillary and mandibular ridges
5. Patients who had no denture fissuratum or any traumas from previous dentures
6. Patients who had no relevant medical issues, disorders of the masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect the response to treatment, oral pathology, xerostomia, or tied tongue condition.
7. Patients had medical and dental insurance to cover the fees for construction of dentures by a Prosthodontic specialist
8. Patients who signed consent form

   -

   Exclusion Criteria:

   -
Registry Study of Genesys HTA for Treatment of Menorrhagia

This is a clinical registry of an FDA approved device system called the Genesys Hydro ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be inserted, by a trained physician, into the uterus, where it will fill and circulate fluid that is warm enough to change the characteristics of the uterine lining. This is done with the anticipated result of improving menstrual bleeding symptoms.

The purpose of this FDA-mandated registry is to obtain clinical experience on the use the Genesys HTA™ system, under normal clinical conditions, and document its safety and technical reliability.


Eligibility Criteria:
Inclusion Criteria:

* Subject must meet the approved indication for use to be considered for this registry.

Exclusion Criteria:

* All subjects contraindicated for the treatment of the Genesys HTA System per the Directions for Use will be excluded:

  1. The subject is pregnant or wants to be pregnant in the future
  2. The subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia
  3. The subject has active pelvic inflammatory disease or pyosalpinx
  4. The subject has hydrosalpinx
  5. The subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath
  6. The subject has an anatomical condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium
  7. The subject has an intrauterine device in place
  8. The subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment
Metabolic Responses to Bariatric Surgery

Research the genetic and biomechanical markers of human adipose tissue on patients with morbid obesity. Additional tissue/fluid collection is also gathered during the time of surgery.

Study participation by invitation after complete pre-surgical work up at UC Davis Health System. Patients will be invited to participate if they meet all inclusion criteria's after completing all necessary clinical visits including lab studies, counseling, and participation in educational programs. During the pre-operative visit patients interested in participation will complete all necessary consent documentation. Pre-operative labs (blood and urine) will be collected along with additional blood, urine, and fecal samples will be collected pre-operatively. During surgery (Roux-en-Y Gastric Bypass surgeries only) tissue collection will include subcutaneous \& omental fat, jejunum, and liver biopsy. Post surgery patient will be observed for weight loss and resolution of co-morbidities. At designated times post surgery when lab studies are ordered additional blood/urine samples will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Meet NIH Criteria for Bariatric Surgery
* Between the Age of 18-55
* Dyslipidemia controlled with medication
* Impaired glucose metabolism or type 2 diabetes

Exclusion Criteria:

* Uncontrolled Metabolic syndrome (uncontrolled diabetes, htn, dyslipidemia), one or all conditions.
Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease

The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Molecular markers that can accurately predict the efficacy of UST are urgently needed to provide theoretical basis for guiding individualized treatment. Therefore, this study intends to explore the impact of intestinal epithelial fucosylation levels on the efficacy of UST in patients with Crohn's disease(CD), aiming to provide predictable molecular markers for UST to accurately treat CD.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with moderate to severe Crohn's disease
2. Receiving treatment with ustekinumab
3. Received colonoscopy and collected intestinal tissue samples before and after treatment

Exclusion Criteria:

1. Pregnancy
2. Hypersensitivity to any component of ustekinumab
3. Cognitive or developmental disabilities prevent you from completing this study
4. Combined with diseases such as RA, diabetes, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis and tumors