cyrilzakka/clinical-trials huggingface dataset:
Autologous Cytokine Induced Killer Cells (CIK) for Patients With Severe Psoriasis

to determine the therapeutic roles of CIK cells on patients with psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Have ever had a physician's diagnosis of chronic moderate to severe plaque psoriasis and be a candidate for treatment with CIK Are being treated with or initiating CIK therapy at the time of enrollment Be able to provide written informed consent Be willing and able to fully to participate for the duration of patient follow-up (5 years)

Exclusion Criteria:

* PUVA or Grenz ray therapy within 4 weeks prior to randomisation. UVB therapy within 2 weeks prior to randomisation. Systemic treatment with biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to randomisation.

Systemic treatment other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine, other immunosuppressants) within 4 weeks prior to randomisation.

Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation (medicated shampoos/emollients are not allowed during the double-blind phase). Shampoos containing corticosteroids, e.g. Clobex®, are not allowed within 2 weeks prior to randomisation.

Planned use of topical treatment for psoriasis of the trunk or limbs, besides study medication, during the study with the exceptions of: • emollient • medications used to treat psoriasis of the skin folds and/or genitals (any medication may be used for this purpose apart from Class 1-5 corticosteroids.

Topical treatment of the face with Class 1-5 corticosteroids within 2 weeks prior to randomisation.

Planned initiation of, or changes to, concomitant medication that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the double-blind phase of the study.

Treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation.

Planned use of chemical treatments of the hair (eg relaxers, 'perms', or colourings) during the double-blind phase of the study.

Current diagnosis of erythrodermic, exfoliative or pustular psoriasis. Patients with any of the following conditions also present on psoriatic areas of the scalp or trunk/limbs: viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, rosacea, acne rosacea, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers or wounds.

Other inflammatory skin diseases that may confound the evaluation of psoriasis of the scalp or trunk/limbs.
The Role of Dry Needling in Hallux Valgus

Forty Hallux valgus patients between the ages of 25-65 years, who are admitted to the Physical Medicine and Rehabilitation clinic with the complaint of 1st Metatarsophalangeal (MTF) pain and who meet the inclusion and exclusion criteria will be included. Hallux valgus (HV) angles will be measured by dorsoplantar radiography before the patients start the study. The HV angle was measured as the angle between the bisection line of the first metatarsal bone and the first proximal phalanx. Demographic data (age, gender, body mass index) will be recorded at the beginning of the study. Then, the initial Foot Functional Index (FFI) and Visual Analog Scale (VAS) scales were completed. The 1st MTF joint angle was also measured with a goniometer and recorded before starting the study. The patients were divided into two groups. The first group will be given 3 sessions of dry needling with Seirin branded 0.6\*50 mm acupuncture needles for trigger point in the abductor hallucis muscle and toe-spread-out exercise. The second group will receive only toe-spread-out exercises. After starting the treatment, FFI and VAS scores and 1st MTF angles will be measured and recorded weekly with a goniometer. At the end of the 3-week treatment, the FFI and VAS scores of the participants will be re-evaluated after 1 week and 1 month, and the participants will be re-evaluated with a goniometer. The hallux valgus angle will be re-evaluated with X-ray 4 weeks after the end of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* 25-65 years old with pain for more than 4 weeks
* Hallux valgus angle between 16-40 degrees
* Activity VAS value above 4

Exclusion Criteria:

* Patients diagnosed with rheumatologic diseases
* Those diagnosed with Diabetes Mellitus (DM), those with chronic liver and kidney failure
* Those who received anti-inflammatory-analgesic treatment in the last 1 week
* Diagnosed with inflammatory rheumatic disease
* Those with a history of foot surgery
* Those with mid or hindfoot deformity
* Those with 1st MTF joint problems other than hallux valgus
* Those with a history of orthotic use
* Previous history of central or peripheral nerve damage, lower extremity neuropathy
* Those diagnosed with Diabetes Mellitus
* Those with cognitive impairment
* Unassisted mobilization
Lipodystrophy Connect Patient Registry

Lipodystrophy Connect is an online survey tool designed to collect demographic data and health information from individuals with Lipodystrophy.

Lipodystrophy is a heterogeneous group of rare and inherited syndromes characterized by the complete or partial loss or absence of subcutaneous adipose tissue. People living with lipodystrophy lack the fat tissue required for normal metabolic function. To enhance knowledge of the underlying biology of these conditions and to institute effective clinical treatments, the Lipodystrophy community has developed a mechanism for individuals with any of the Lipodystrophy conditions to enroll in a Lipodystrophy registry called Lipodystrophy Connect. The objective of such a registry is to create a platform that connects all of the Lipodystrophy community, including persons with Lipodystrophy, family members, healthcare providers, researchers, drug companies, advocacy groups, federal research organizations, and regulators. A patient registry will provide the foundation for a resource to meet the current and future needs of the Lipodystrophy community as well as accelerate the rate of research and development of therapies that improve the quality of life of those with Lipodystrophy. Lipodystrophy Connect is an online survey tool that collects basic demographic information and health information from people with any rare form of Lipodystrophy.

Eligibility Criteria:
Inclusion Criteria:

* Adults, \> 18 years of age, with a diagnosis or suspected diagnosis of lipodystrophy, who are willing and able to provide informed consent, or for whom a legally authorized representative gives permission on behalf of the person to participate.
* Minors (less than 18 years of age) with a diagnosis of lipodystrophy with a parent(s) or legally authorized representative who provides informed consent to participate and enter registry information on behalf of the minor. Note: Minors who are 7-17 years of age will be asked to provide assent to participate.
* Adults \> 18 years of age, without lipodystrophy, who are willing and able to provide informed consent and are family members of patients diagnosed with familial partial lipodystrophy (FPL) or congenital generalized lipodystrophy (CGL) and want to provide information about themselves.

Exclusion Criteria:

* A person who does not have a suspected or confirmed diagnosis of Lipodystrophy.
* A person who has a known diagnosis of HIV-associated Lipodystrophy.
TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck

This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.

This is a single arm Phase II study of adjuvant radiation for locally-advanced p16+ oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N2b, M0 disease (per AJCC 7th ed) with \<5 positive lymph nodes, will be eligible. Patients will have undergone TORS primary site resection and ipsilateral neck dissection. Patients will undergo radiation dose reduction and target volume reduction.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years old
* Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry
* Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 7th Ed)
* Pathologic N0, N1, N2a, or N2b disease (per AJCC 7th Ed), with \< 5 positive lymph nodes
* ECOG Performance Status 0-1

Exclusion Criteria:

* Prior radiation therapy to the head and neck
* Presence of T4 disease
* Presence of N2c or N3 neck disease (per AJCC 7th Ed)
* \>= 5 lymph nodes
* Presence of distant metastatic disease
A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone

This is a retrospective observational real-world study, which evaluates the efficacy and safety of denosumab and non-denosumab therapies in the treatment of Chinese populations of surgically unsalvageable or severe post-surgery morbidity associated giant cell tumor of bone (GCTB), collectively referred to as unresectable GCTB, during 2013-2021 in three medical centers, serving as the external control for a single arm phase Ib/II trial on JMT103 treatment of GCTB. 301 patients were enrolled and divided into 2 groups according to their actual previous exposures. Group 1 (n=135) was denosumab group. Group 2 (n=166) included two types of exposures other than denosumab: other anti-GCTB drug therapies, or no therapy on GCTB patients. The dosage, route, frequency and other administration methods was collected according to the actual previous treatment records. The primary outcome measure was the tumor response rate \[radiographic tumor response (CR/PR evaluated by ICDs or EORTC criteria) within 12 weeks, or at least 90% reduction of osteoclast like giant cells compared with baseline\]. The key secondary endpoint was the tumor response rate \[radiographic tumor response (CR/PR evaluated by ICDS or EORTC criteria), or at least 90% reduction of osteoclast like giant cells compared with baseline\]. Other secondary Outcome Measures include: proportion of patients whose tumors was surgically resectable; median duration of tumor response (DOR), disease control rate (DCR), and time to disease progression (TTP); and types and proportion of key adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* 1. Both genders, aged 18 years or above;
* 2. Patients pathologically diagnosed of giant cell tumor of bone (GCTB), and are surgically unsalvageable, or salvageable but surgery was associated with severe morbidity based on physician's judgement;
* 3. For patients received denosumab or other anti-GCTB medications, one of the two is required: imaging data (including X-ray, CT, MRI or PET-CT) prior to and at least once followed to administration, or pathological data on surgically resected GCTB; for patients with no medication, imaging data or pathological data on surgically resected GCTB is required.

Exclusion Criteria:

* 1. No access to definite treatment information;
* 2. Bone metabolic diseases diagnosed before treatment: hypo-/ hyperparathyroidism, hypo-/hyperthyroidism, hypopituitarism, hyperprolactinemia, Cushing syndrome, acromegaly, Paget disease, etc;
* 3. Complication of malignant tumor receiving anti-tumor therapy.
PK and Safety of SI-722 in IC/BPS

This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, ≥18 and ≤80 years of age
* A score of 19 or greater on the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)

Exclusion Criteria:

* Urinary tract infection ≤30 days
* Treatment with intravesical therapy ≤60 days
* Treatment with any opioid therapy ≤7 days
* History of bladder hydrodistension ≤3 months
* Has cancer or a past history of any cancer ≤5 years
* Body mass index (BMI) ≥40 kg/m2
Operative Curriculum Gallbladder Surgery

The goal of this study is to implement and evaluate the need, feasibility and effectiveness of a resident-initiated, step-wise, graduated operative curriculum designed to enhance resident autonomy for laparoscopic cholecystectomy for general surgery residents.

The goal of this study is to improve resident autonomy and confidence through detailed and stepwise feedback and to also assess resident and attending perceptions regarding resident skill and autonomy.

Eligibility Criteria:
Inclusion Criteria:

* All Mayo Clinic general surgery residents and attendings across all campuses

Exclusion Criteria:

* None
A Study of Remimazolam Tosilate for Sedation in the ICU

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.


Eligibility Criteria:
Inclusion Criteria:

1. Patients or their guardians are able to provide a written informed consent；
2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria；
3. 18 Years to 80 Years Old, male or female；
4. 18 kg/m2≤BMI≤30kg/m2；

Exclusion Criteria:

1. Deep sedation is required, or continuous sedation is not needed during the study process；
2. Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
3. History of epilepsy or status epilepticus;
4. Myasthenia gravis or a history of myasthenia gravis;
5. Severe arrhythmias or heart disease; the circulatory system is unstable;
6. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness；
7. Subjects with a history of drug abuse;
8. Organ failure before randomization;
9. Abnormal values of the laboratory examination;
10. Allergic to relevant drugs ingredient or component;
11. Pregnant or nursing women;
12. Subjects who has participated in clinical trials of other interventions recently;
13. Other conditions deemed unsuitable to be included.
Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia

This is an investigator initiated prospective study to determine whether the use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic Swallowing Exam (VFSE) among patients with oropharyngeal dysphagia.

During a properly coordinated swallow, the oropharynx, larynx, and hypopharynx undergo a series of movements that serve to prepare and expand the pharyngoesophageal segment (PES), which is the inlet into the esophagus. Under normal circumstances, a food bolus is safely propelled from the oropharynx, through the PES, and into the esophagus. Surgical and radiation therapy in the head and neck, as well as deficiencies such as poor coordination, mistiming, or obstructing lesions may prevent the food bolus from safely entering the esophagus and instead diverting toward the trachea.

A number of patients with severe oropharyngeal dysphagia are not able to tolerate any diet without risking aspiration and subsequent pneumonia, often to a degree severe enough that they cannot manage to safely swallow their secreted saliva. These patients depend on a gastrostomy feeding tube in order to obtain adequate daily nutritional requirements and must suction or spit out their saliva to prevent aspiration and a sensation of asphyxiation. Despite these precautions, many of these patients ultimately suffer life-threatening pneumonia. Investigators will be testing if the use of use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic Swallowing Exam (VFSE) among patients with severe oropharyngeal dysphagia

Eligibility Criteria:
Inclusion Criteria:

* Patients with videofluoroscopic evidence of aspiration with Rosenbek Penetration Aspiration Scale (PAS) greater than 5 for all tested food consistencies
* Gastrostomy tube dependence
* Exhaustion of conventional treatment options (physical, medical, and surgical therapies)

Exclusion Criteria:

* Complete PES stricture
* Inability to follow commands
* Current malignant disease
* No gastrostomy tube present
* Less than two years of cancer-free survival (if applicable)
* Vulnerable populations: adults unable to consent, pregnant women, and prisoners
Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18-75 years (inclusive)
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
* Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator
* Subjects who are able to use effective contraception from the screening period to 6 months after the last dose

Key Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline
* Drug-induced psoriasis
* Ongoing use of prohibited treatments
* Any active infection (other than common cold) within 14 days
* Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization
* Have previously received any drug that directly targets IL-17 or IL-17 receptor
* Have concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab and adalimumab \<60 days; golimumab \< 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs \<6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization
* A history of inflammatory bowel disease or other serious autoimmune disease
* Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency
Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

Acute kidney injury is major complication after open heart surgery. The cause of acute kidney injury following open heart surgery is related to activation of sympathetic nervous system, decrease of renal blood flow, ischemia-reperfusion injury and systemic inflammatory response.

Infective endocarditis patients undergoing open heart surgery have systemic inflammatory response associated with infective endocarditis. And the inflammatory response can be aggravated by cardiopulmonary bypass. The incidence of acute kidney injury following open heart surgery due to infective endocarditis was 50% in a previous report. And this acute kidney injury was related to the poor outcome and high mortality. Thus, the preventive method to protect kidney function will be needed in the patients with infective endocarditis undergoing open heart surgery.

Dexmedetomidine is a selective α2-agonist and has sedative, analgesic, and CNS depressive effect. And several experimental study demonstrated the renal protective effect. Intraoperative dexmedetomidine administration can reduce the amount of anesthetics needed and suppress the sympathetic response resulted by surgical stimulation. And dexmedetomidine was reported to reduce the level of serum cortisol, epinephrine and norepinephrine during the operation. Thus, these effects of dexmedetomidine can be expected to reduce the incidence of acute kidney injury.

Therefore, the investigators hypothesized that dexmedetomidine has renal protective effect and this effect might be related to the suppression of inflammatory response. Thus, the investigators will evaluate the incidence of acute kidney injury and the incidence of major adverse kidney events (MAKE) after open heart surgery due to infective endocarditis and the level of inflammatory mediators.

The primary end point of this study is the incidence of acute kidney injury after open heart surgery due to infective endocarditis. And secondary end point is the incidence of MAKE, the level of cystatin C which is related to the renal function, the level of inflammatory mediator and the postoperative morbidities.


Eligibility Criteria:
Inclusion Criteria:

* patients with infective endocarditis
* patients who are scheduled to undergo open heart surgery

Exclusion Criteria:

* chronic kidney disease
* taking high dose steroid (\>10mg/day prednisolone or equivalent)
* age under 20 years
* cognitive dysfunction
* disabling mental change disorder
* unable to communicate or speak Korean
The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.

In this study, the investigators are going to examine the effect of metformin on obesity and metabolic disturbance in patients with schizophrenia who have taken clozapine.The metformin 500mg will be administrated per oral twice a day for 24 weeks and for control group, placebo will be given same route and process.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 \~ 65
* Patient with schizophrenia according to DSM-IV criteria
* Patient have signed on the informed consent, and well understood the objective and procedure of this study.
* Patient taking clozapine 3months or more
* Patient increased in weight more than 10 % of that of before antipsychotics use

Exclusion Criteria:

* Patient taking other antipsychotics with clozapine
* Patient in treatment of diabetes
* Patient in treatment of dyslipidemia
* Allergy or hypersensitivity to metformin
* Pregnant or breast-feeding female patient.
* Patient with severe medical condition
Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Oro-antral Fistula

Oroantral fistula (OAF) is a pathological communication between the oral cavity and the maxillary sinus. A variety of surgical techniques have been developed, with recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection. To increase the success rates of OAF closure procedures, the use of double-layered closure techniques has developed, but most of these techniques alter the original oral anatomy and may result in significant postoperative morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Large Oro-antral Fistula
* Recent or previously failed closure of oro-antral Fistula

Exclusion Criteria:

* Immuno-supressed patients
* fistulae smaller than 5 mm in size