cyrilzakka/clinical-trials huggingface dataset:
China Rheumatoid Arthritis Registry of Patients With Chinese Medicine

A multi-center registration study of clinical characteristics of rheumatoid arthritis (RA) patients with Chinese medicine.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilled the rheumatoid arthritis classification criteria of 2010 American College of Rheumatology (ACR)/the European League Against Rheumatism (EULAR) .
* Aged 18 years and older.
* Be willing to accept CM therapies defined as Chinese herbal medicine, Chinese patent medicine, external treatment, acupuncture and moxibustion, etc

Exclusion Criteria:

* Refuse informed consent.
Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers

This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of personally signed and dated informed consent document.
* Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
* Subjects must avoid high intensity UV light exposure (eg, active sunbathing, tanning beds/booths or sunlamps) from the first dose of study drug and for the duration of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Screening blood pressure \>140/90 mm Hg.
* Screening laboratory abnormalities as defined by the protocol.
* Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer

Phase I trial to study the effectiveness of low-dose radiation therapy to the abdomen combined with docetaxel in treating patients who have recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose of docetaxel in combination with low-dose abdominal radiotherapy in patients with recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer.

II. Determine the safety and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of docetaxel.

Patients receive docetaxel IV over 30 minutes once daily on days 1, 8, 15, 22, 29, and 35. Within 3 hours after beginning docetaxel, patients also receive low-dose abdominal radiotherapy twice daily (at least 4 hours apart) on days 1, 2, 8, 9, 15, 16, 22, 24, 29, 30, 35, and 36. Treatment continues in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ovarian, peritoneal, or fallopian tube carcinoma
* Radiographic, clinical, or pathologic evidence of relapse
* Recurrent or persistent disease after chemotherapy (may be enrolled at first or subsequent relapse)

  * Received prior taxane OR platinum agent
* Performance status - GOG 0-1
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT/SGPT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No grade 2 or greater neuropathy (sensory or motor)
* No septicemia
* No severe infection
* No circumstance that would preclude study completion
* No prior radiotherapy to the abdomen or pelvis
* Patients with ureteral obstruction must undergo stent or nephrostomy tube replacement prior to study entry
Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)

The purpose of this study is to assess whether an AI based counseling service can be beneficial for patients to assist in management of gestational diabetes.

Gestational diabetes mellitus (GDM) affects approximately 6-9% of pregnancies globally, posing significant risks to both maternal and neonatal health. Standard management includes dietary counseling, glucose monitoring, and insulin therapy when necessary. However, the rising prevalence of GDM and limited healthcare resources necessitate innovative solutions to supplement traditional care. Generative Pre-trained Transformers (GPTs), a type of large language model (LLM), offer personalized, real-time counseling and support. Recent advancements in AI have shown promise in various healthcare applications, but the efficacy of GPT-based counseling in GDM management remains underexplored. This study builds on preliminary evidence suggesting that AI can enhance patient engagement and outcomes, aiming to validate these findings in a controlled trial.

The integration of AI, specifically GPTs, into healthcare can revolutionize patient management by providing continuous, tailored support. This study aims to evaluate whether GPT-based counseling can improve glycemic control and patient satisfaction in GDM management, compared to traditional counseling alone. By placing AI within the context of prenatal care, this research seeks to address gaps in current GDM management practices and offer scalable, personalized solutions.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45
* Diagnosed with GDM in pregnancy
* Able to use a smartphone
* Fluent in English or Spanish

Exclusion Criteria:

* Pre-existing diabetes
* High-risk pregnancies due to other medical conditions
* Inability to consent
* Non-English and/or Non-Spanish speakers
* No smartphone access
A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
* Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA
* Positive serum RF
* Current treatment for RA on an outpatient basis
* Contact your local site that is listed for more inclusion criteria

Exclusion Criteria:

* Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
* Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome)
* Functional Class IV as defined by the ACR classification of functional status in RA
* History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome)
* Contact your local site that is listed for more exclusion criteria
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)

This is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for up to 12 months


Eligibility Criteria:
Inclusion Criteria:

1. Histologically documented diagnosis of GBM.
2. Immunohistochemical documentation of expression of PDGFR.
3. Unresectable, recurrent disease by MRI and spectroscopy

Exclusion Criteria:

1. Treatment with any other investigational agents within 28 days of first day of study drug dosing.
2. Concurrent chemotherapy.
3. Concurrent radiotherapy.

Other protocol-defined exclusion criteria may apply.
PSYCHOLOGICAL CARE AND HYPNOSIS IN PATIENTS WITH CANCER

The general aim of the research that we propose to implement is to study the potential benefits of hypnosis in the psycho-social care of patients with cancer. The main goal of this study is to measure the effects of hypnosis sessions on quality of life, anxiety and patient adjustment strategies. The effects of these interventions will be the subject of quantitative measurement via standardized scales in pre- and post-intervention situations of the potential effects of hypno-therapeutic intervention in cancer patients and


Eligibility Criteria:
Inclusion Criteria:

* Patient with any kind of cancer and followed by a psychologist

Exclusion Criteria:

* Patient with neurological trouble
* Patient with psychiatric decompassation
The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty

In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal anesthetic outcome by logistic regression analysis.

Although the spread of spinal anesthetic drug is unpredictable, patients factors (age, gender, height,weight, body-mass index), spinal anatomy, anesthetic drug dose, and lumbosacral cerebrospinal fluid volume are known to be the determinants of sensory block level. Among these determinants, the influence of body-mass index (BMI) on spinal anesthesia is controversial, and there is no specific guideline showing the relative priority of these determinants.

Therefore, in these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the relative influence of these determinants on spinal anesthetic outcome by logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
* American Society of Anesthesiologist Physical Status classification I \~ III

Exclusion Criteria:

* Bupivacaine allergy
* medical history of spinal surgery
* Diabetic neuropathy
* active infection at the lumbosacral area
* other contraindication of spinal anesthesia
Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

Diabetes increases the incidence and severity of periodontal inflammation and disease, and periodontal disease causes an increase in the severity of diabetes by worsening glycemic control and increasing insulin resistance.The Transmucosal Herbal Periodontal Patch (THPP) is a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on gingival tissue.The primary objective of this study is to determine the efficacy of the Transmucosal Herbal Periodontal Patch (THPP) compared with placebo patch (PP) in reducing gingival inflammation at the site of placement in diabetic patients. We also aim to determine if the THPP decreases gingival inflammation throughout the mouth and the safety of THPP compared with placebo patch when applied to the mucosa in the treatment of gingival inflammation in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18 and 85 years
* Patients must have a minimum of 3 posterior teeth in all quadrants
* A mean gingival index (GI) of \>1.5 on the posterior teeth
* Diagnosis of Diabetes type 1 or 2, adequately controlled by diet and/or medications, as determined by the patient's physician

Exclusion Criteria:

* Allergy to any herbal medications
* Pregnancy or lactation
* Periodontal treatment in the last three months
A Phase I/II Study of Mitoxantrone Liposome Combined With Chidamide in Relapsed/Refractory Peripheral T-cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous group of aggressive non-Hodgkin lymphoma (NHL) originating from mature thymus T cells.Mitoxantrone Hydrochloride Liposome Injection can accelerate the entry of mitoxantrone into cells, reduce the efflux of mitoxantrone, ensure the concentration of intracellular drugs, reverse the drug resistance mechanism, and enhance anti-tumor activity.We will explore the dose-limiting toxicity (DLT) of Mitoxantrone Hydrochloride Liposome Injection combined with Chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma, estimate the maximum tolerated dose (MTD) of the combination, and determine the phase II recommended dose RP2D.In the phase II study, we will evaluate the safety and efficacy of the combination regimen.

This study was a single-arm, open, multicenter phase I/II clinical study. An estimated 87 to 96 patients with relapsed or refractory PTCL will be enrolled. This program is divided into two parts:

The phase I study is expected to enroll 9 to 18 patients with relapsed or refractory PTCL who will be treated with Mitoxantrone Hydrochloride Liposome Injection combined with Chidamide.The phase II study is expected to enroll 78 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients participated voluntarily and signed informed consent；
* PTCL confirmed by histopathology；
* There must be at least one evaluable or measurable lesion that meets Lugano2014 criteria；
* The ECOG score is 0 to 1；
* ANC≥1.5×10\*9/L，PLT≥75 × 10\*9/L；HB≥80 g/L；TBIL≤1.5ULN；ALT or AST≤2.5 ULN； Scr≤1.5ULN；
* Use contraception during treatment and for one year after the end of treatment.

Exclusion Criteria:

* Patients with central nervous system (CNS) involvement and/or hemophagocytic syndrome；
* The estimated survival time is less than 6 months；
* History of allergy to anthracyclines or liposomes; Previous recipients of mitoxantrone or mitoxantrone liposome;Previous treatment with doxorubicin or other anthracyclines had a cumulative dose of doxorubicin \> 360 mg/m2（For other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin, and the maximum cumulative dose of liposomal doxorubicin is 2460mg/m2）；
* The use of Chidamide is contraindicated;
* Impaired heart function or significant heart disease;
* Hepatitis B, hepatitis C active stage infection;
* Had undergone major surgery within 4 to 6 weeks prior or expected to undergo major surgery during the study;
* severe infection;
* Poorly controlled high blood pressure or diabetes;
* A history of active visceral bleeding within the previous 3 months
* A history of malignancy within five years;
* History of mental illness;
* A history of substance abuse or dependence;
* pregnant or lactating woman;
* The investigators did not consider it appropriate to participate in this study.
Prospective Multicenter Study With the Endomina® Triangulation Platform

This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice

This is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. This registry is designed to further assess on a larger scale safety and efficacy of the endomina® and TAPES devices. Patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be willing to provide written informed consent
* Adult patients (between ≥ 18 years (legal age in Europe) and 65 years of age at time of ESG)
* Patients who require endoscopic gastroplasty and who are selected by multidisciplinary team/investigators to be treated with the endomina® device and accessories according to the Instructions for Use (IFU)

Exclusion Criteria:

* Patients with impaired hemostasis or pre-existing conditions that may lead to fragile mucosa (i.e., any contraindication to suturing the stomach)
* Any malformation from mouth to esophagus (including pharynx)
* Any contraindication to general anesthesia, including patients with cardiorespiratory dysfunction or respiratory failure
* Woman who are pregnant, at the time of the procedure or planning (trying) to become pregnant, or nursing within 12 months after the procedure.
* Impending surgery 60 days post intervention of the treated section of the GI tract
* Participation in another clinical study evaluating another medical device, another procedure or a medication that did not reach its primary endpoint
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.

* double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial.
* Experiment duration: 04 days.
* 03 visits (days 0, 2 and 4).
* Efficacy will be evaluated for back pain relief based on visual analog scale.
* Adverse events evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Consent of the patient or legal guardian.
* Men or women aged between 18 and 65.
* Diagnosis of acute low back pain with moderate to severe pain (Visual Analog Scale greater than 4 cm)

Exclusion Criteria:

* fracture confirmed by X-ray
* Diagnosis of infection, fever,
* Pregnancy, lactation;
* Diagnosis of fibromyalgia;
* Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory
Inhibitory Control and Eating Disorders

Executive functions are part of the high-level cognitive processes essential to the proper functioning of human cognition. They consist mainly of flexibility, updating and inhibition. Some studies have shown a correlation between executive disorders (impaired executive function) and psychiatric disorders such as obsessive-compulsive disorder or phobias. These executive disorders are related to dysfunctions of the fronto-striatal loops.

In addition, other studies have investigated the link that may exist between eating disorders such as anorexia or bulimia nervosa and executive functioning. Anorexia nervosa, bulimia nervosa and binge eating disorders are eating disorders characterized by a dysfunction in food intake with restriction of food or compulsions as well as strong concerns about the body schema. Concerning the executive functioning, these studies highlight a lack of cognitive flexibility for patients with anorexia nervosa and bulimia nervosa but also dysfunctions depending on the type of pathology (anorexia nervosa or bulimia nervosa). These studies also highlight the beneficial effects of cognitive remediation on people with eating disorders.

However, the investigation of the inhibitory control has not yet been specifically studied. Moreover, since eating disorders are structurally different, a comparison between several pathologies would be interesting to consider.

The aim of this study is to determine if a dysfunction of inhibitory control can be highlighted in people with eating disorders. This study would also allow further researches about cognitive remediation suitable for the specific difficulties encountered in these diseases.


Eligibility Criteria:
Inclusion Criteria:

* Woman aged 19 to 40 years old
* Patient with a BMI between 13 and 40 kg/m2
* Outpatients of the Refering Center of Eating Disorders ('Hospices Civils de Lyon' in Lyon) suffering of an eating disorder diagnosis (Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder)
* Patient who agrees to participate to the study.

Exclusion Criteria:

* Patient with psychiatric comorbidity severe (DSM V) and not stable (during the 8 weeks before inclusion)
* Patient with psychotropic treatment (started or modified during the 8 weeks before inclusion)
* Major patient protected by a measure of legal protection
* Patient younger than 19 years old
* Participation to another study at the same time
Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area

Onchocerciasis is a neglected tropical disease associated with epilepsy, particularly in areas of high Onchocerciasis volvulus transmission. Onchocerciasis-associated epilepsy is characterised by seizures that start between the ages of five to 18 years. The tropical disease can be controlled through community-directed treatment with ivermectin (CDTi). Mahenge, in Tanzania, had a high prevalence of onchocerciasis and epilepsy despite more than 20 years of annual CDTi. Hence, the Tanzanian Neglected Tropical Diseases Control Programme has switched from annual to bi-annually CDTi since 2019. After this switch, the CDTi coverage increased and was sustained in both ivermectin rounds in 2021, and the number of new epilepsy cases decreased. The latter were persons who did not take ivermectin the year they had the first seizures. Hence, all ivermectin-eligible children at risk of onchocerciasis should take ivermectin at least annually. Overall, increasing the frequency and coverage of the CDTi programme should be considered in onchocerciasis-endemic areas with a high prevalence of epilepsy.

Background: Community-directed treatment with ivermectin (CDTi) is used to eliminate onchocerciasis. However, despite 25 years of annual CDTi in Mahenge, Tanzania, the prevalence of onchocerciasis and onchocerciasis-associated epilepsy remained high in certain rural villages. Therefore, in 2019, bi-annual CDTi was introduced in the area. This study assessed the impact of the programme on the incidence of epilepsy in four villages.

Methodology: Door-to-door epilepsy surveys were conducted prior to (2017/18) and after (2021) implementing bi-annual CDTi. All household members were screened for epilepsy symptoms using a validated questionnaire, and suspected cases were examined by a medical doctor to confirm/reject the diagnosis of epilepsy. The prevalence and annual incidence of epilepsy, including nodding syndrome, were calculated with 95% Wilson confidence intervals with continuity correction. The latter was also done for CDTi coverage in 2021.

Eligibility Criteria:
Inclusion Criteria: whole population -

Exclusion Criteria: No

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