cyrilzakka/clinical-trials huggingface dataset:
Clinical, Genetic and Epigenetic Characterization of Patients With FSHD Type 1 and FSHD Type 2

The aim of the study was to compare the severity of illness between groups of patients (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2).

Despite advances in research on the subject, answers are still needed on these diseases.

We also aim to determine whether the chromosomal genetic abnormality is involved in other diseases and the frequency of this mutation in the population of patients FSHD.

This study will increase our knowledge of the two forms of FSHD who present a common pathophysiological mechanism and may occur together in the same family with a worsening of the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1 and type 2 seems to have clinical consequences requiring appropriate management


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years and \<75 years
* FSHD patients 1 or 2 with or without genetic confirmation

Exclusion Criteria:

- Patient with all conditions considered by the investigator interfering with the proper conduct of the study.
Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes

This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion Criteria:

* In accordance with approved label
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination with letrozole in the first-line treatment of Japanese patients with ER(+) HER2(-) ABC. The Phase 2 portion is a single-country, non-randomized, open-label, single-cohort, multi-center clinical trial to evaluate the efficacy and safety of PD-0332991 in combination with letrozole for the first-line treatment of postmenopausal Japanese patients with ER(+) HER2(-) ABC.


Eligibility Criteria:
Inclusion Criteria:

Phase 1

* In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically or cytologically at original diagnosis, that is refractory to standard therapy or for whom no standard of care therapy is available.
* In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease) not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
* Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group \[ECOG\] score of 0 or 1.
* Resolved acute effects of any prior therapy to baseline severity or Grade ≤1

Phase 2

* Adult women (≥ 20 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
* Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast cancer based on local laboratory results.
* Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group \[ECOG\] score of 0 to 2.

Exclusion Criteria:

Phase 1

* Active uncontrolled or symptomatic CNS metastases.
* Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse
* Active or unstable cardiac disease or history of heart attack within 6 months

Phase 2

* HER2 positive tumor based on local laboratory results utilizing one of the sponsor approved assays.
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
* Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.
Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Dacryocystorinostomy (DCR) is an operation that is indicated for lacrimal duct obstruction. As a result of the lacrimal duct obstruction, tears are retained over the obstacle and repeated lacrimal infections occur. During DCR, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently drained into the nasal cavity. The most common cause of unsuccessful surgery is intranasal stoma scarring. One of the methods that can increase the success rate of surgery is the introduction of silicone stent into the lacrimal duct during DCR, so-called bicanalicular intubation of the lacrimal system. The aim of the study is to compare long term effectiveness of DCR with and without bicanalicular intubation.

Dacryocystorinostomy (DCR) is an operation that is indicated for lacrimal duct obstruction. Lacrimal duct obstruction can be caused by inflamation and trauma or might be the consequence of previous surgery in the lacrimal duct region. As a result of the lacrimal duct obstruction, tears are retained over the obstacle and repeated lacrimal infections occur. During DCR, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently drained into the nasal cavity. The results of DCR are generally excellent and the success rate (regression of complaints) varies between 85-95% depending on the condition of the lacrimal pathways before surgery. Yet there is a constant effort to improve the results of operations. The most common cause of unsuccessful surgery is intranasal stoma scarring. It is caused by an inadequately formed bone window, an individual tendency to healing and scar formation, but a frequent cause is the insufficient opening of the tear bag or the formation of scars between the nasal septum and the lateral nasal wall. One of the methods that can increase the success rate of surgery is the introduction of silicone stent into the lacrimal duct during DCR, so-called bicanalicular intubation of the lacrimal system. Silicone stent remains in the lacrimal system for 12 weeks and prevents scarring. Results of previous studies are not clear whether bicanalicular intubation is beneficial. The aim of the study is to compare long term effectiveness of DCR with and without bicanalicular intubation.

Eligibility Criteria:
Inclusion Criteria:

* patients with lacrimal duct obstruction
* 18 to 79 years of age
* capable of general anesthesia
* signing of the informed consent

Exclusion Criteria:

- inability to undergo general anesthesia
Predicting Tumor Origin Based on Deep Learning of Lymph Node Puncture Cytology

In this study, the investigators aimed to construct a deep learning diagnostic model that uses cytological images to predict primary unknown tumor origins in patients with tumors combined with lymph node metastases. After the model is constructed, the model will be validated by a large-scale test set to test the model performance. The investigators also propose to compare the performance of the constructed model in diagnosing cytology smears compared to human pathologists.


Eligibility Criteria:
Inclusion Criteria:

* From West China Hospital of Sichuan University (October 1, 2008-August 31, 2024) with corresponding clinical data, including age, sex, specimen puncture site, pathologic diagnosis, pathologic type, whether immunocytochemistry was added, clinical diagnosis, lesion site, co-morbidities, history of malignancy, treatment modality, occurrence of postoperative complications, total number of days of hospitalization postoperatively, and survival time;
* From the Department of Pathology of the First Affiliated Hospital of Zhengzhou University, the Sichuan Provincial Cancer Hospital, and the Cancer Hospital of the Chinese Academy of Medical Sciences (January 1, 2020-August 31, 2024) with corresponding clinical data, including age, sex, specimen puncture site, pathologic diagnosis, pathologic type, whether immunocytochemistry was added, clinical diagnosis, lesion site, co-morbidities, history of malignancy, treatment modality, occurrence of postoperative complications, total number of days of hospitalization postoperatively, and survival time.

Exclusion Criteria:

* Images lacking any supporting clinical or pathologic evidence to support a primary origin and its corresponding clinical information;
* Blank, poorly focused, and low-quality images containing severe artifacts and their corresponding clinical information.
Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing

The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.


Eligibility Criteria:
Inclusion Criteria:

1. Biologically male
2. Aged 18 or older
3. Fluent English speaker
4. Unprotected anal sex with a casual male partner at least once in the past 3 months
5. Heavy alcohol use during the past 2-weeks (\>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion)
6. Breath alcohol concentration (BrAC) of .000 at the time of enrollment
7. No history of complex alcohol withdrawal
8. HIV-negative

Exclusion Criteria:

1. Individuals who are HIV-positive
2. Individuals who participated in other phases of the research
3. Individuals who report being coerced to participate
EMMA-1 (Erbitux for Multiple Myeloma)

EMMA-1 is an open-label, non-randomized, two-stage phase II study. Patients with refractory multiple myeloma stage II or III or relapsed disease after at least one line of treatment will receive Cetuximab+/-Dexamethasone.

The planed treatment duration per patient is 16 weeks. Patients achieving a response or stable disease after 16 weeks of treatment may continue study medication for 6 more months (patients receiving Cetuximab alone) or for 3 more months (patients receiving Cetuximab plus Dexamethasone). Responding patients who relapse during follow-up period of two years may receive a second treatment with Cetuximab following initial study guidelines


Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma diagnosed according to the Durie-criteria in stage II or III (Salmon and Durie)
* Measurable disease
* Refractory or relapsed disease after at least one line of treatment
* Male or female \>= 18 years of age
* Life expectancy \> 12 weeks
* ECOG performances status 0-2
* If of childbearing potential, willingness to use effective contraceptive method for the study duration and 6 months post-dosing.
* No surgery, radiotherapy or chemotherapy or any investigational agent within 30 days of study entry
* Signed written informed consent

Exclusion Criteria:

* Asecretory multiple myeloma
* Patients eligible and willing to undergo high dose chemotherapy followed by autologous stem cell transplantation
* Prior allogeneic transplantation
* Prior antibody or EGFR-pathway targeting therapy
* Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency \> NYHA-II
* HIV Infection, Hepatitis B or C
* Brain disorders, psychiatric illness
* Insufficient bone marrow reserve (Leucocytes \< 1500/µl; Thrombocytes \< 50000/µl)
* Creatinine-Clearance \< 30 ml/min or Crea \> 3.0 mg/dl
* Bilirubin \> 2 mg/dl; ASAT, ALAT \> 100 U/l
* Pregnancy (absence confirmed by serum/urine beta-HCG) or breast-feeding
* FEV1 \< 50% of the reference value
* Active secondary malignancy
* Legal incapacity or limited legal capacity
* Having participated in another clinical trial or any investigational agent in the preceding 30 days
* Known allergic/hypersensitivity reaction to any compounds of the treatment
* Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
* Known drug abuse/alcohol abuse
A Randomized Trial to Assess the Efficacy and Safety of GO2KA1(Chitosan Oligosaccharide)on Blood Glucose Control

The effects of chitosan on blood glucose levels have been contradicting. Hypoglycemic effects of high molecular weight chitosan are related to diabetic models with hypoinsulinemia but have shown little effect on the blood glucose levels in hyperinsulinemia related diabetic models. Based on previous reports, high molecular weight chitosan either directly or indirectly related to insulin secretion in pancreas but has little effect on insulin resistance. In the present study, the effect of GO2KA1 (low molecular weight chitosan oligosaccharide) on blood glucose levels in Korean pre-diabetic adults, will be evaluated. The changes in postprandial blood glucose levels will be investigated in subjects with impaired fasting glucose or glucose tolerance.

In the detailed description we believe that it will be wise to discuss about the long-term study of the effect of GO2KA1(Chitosan oligosaccharide: oligosaccharides derived from chitosan) on pre-diabetic individuals (in addition to the postprandial blood glucose levels). In the present study, we will investigate the effects of GO2KA1 on the level of postprandial blood glucose in adult Koreans with impaired fasting glucose or impaired glucose tolerance. Postprandial blood glucose levels will be tested for 2 hours at every 30 min interval after 75g-OGTT and the experimental group will be pre-fed with 500 mg of GO2KA1. Primary outcomes will be included change in HbA1c, insulin, glycemic AUC, and lipids(total cholesterol, triglyceride, and HDL).

This clinical study will be conducted with 60 subjects after explanation and accommodation about experimental protocols and model. To test under same condition, smoking and drinking water will be completely prohibit from 1 hour before and during the experiment. At first day, control experiment will be conducted without oral take of GO2KA1 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* males and females 20-75 years old
* impaired fasting glucose (FPG 100\~125 mg/dL) or impaired glucose tolerance (PPG-2h 140\~200 mg/dL)
* able to give informed consent

Exclusion Criteria:

* having received a diagnosis of diabetes or receiving treatment for diabetes
* having a history of ischemic heart disease, stroke, liver cirrhosis, chronic pancreatitis, pituitary disease, thyroid disease, adrenal gland disease, mental illness, gastrectomy, or advanced malignant tumor
* receiving corticosteroid or thyroid hormone medication
* being judged by the responsible physician of the local study center as unfit to participate in the study
* abnormal liver or kidney function tests (ALT or AST \> 2 times the upper limit of normal
* elevated creatinine, males \> 125 umol/L, females \> 110 umol/L)
Efficacy of a Nursing Intervention in First-time Mothers

Experimental study will determine the efficacy of nursing intervention named Maternal support to become first-time mothers based on the theory of Ramona Mercer. Sequential explanatory design will be used. It is a mixed design with approach quantitative and qualitative in order to obtain a better approach of the phenomen. The approach quantitative will be randomized controlled clinical trial. The qualitative analysis of the content will be done according to Bardin.

Taking into account the scientific literature related to studies in first-time mothers with healthy newborns, it can be concluded that the limited success of interventions that have been made suggests that the main areas of becoming a mother have not been addressed, either as part of the content or process of the interventions. This study will be conducted in 24 months. The sample size calculated will be 74 first-time mothers in total, which are allocated in two groups, intervention and control. Each group with 37 mothers.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum stage (for vaginal or for cesarean delivery)
* Mother of a healthy full term newborn.
* First-time mother.
* Self-declared support by her couple.
* Mother living in Bucaramanga metropolitan area

Exclusion Criteria:

* Multiple pregnancy.
* Mothers who cannot read or write.
* Diagnosis of postpartum depression, mental disorders, behavioral disorders.
* Mothers admitted to the intensive care unit after childbirth.
* Mothers with newborns hospitalized in the intensive care unit, intermediate care or minimal care.
Mantle Irradiation for Hodgkin's Disease

The purpose of this study it to evaluate the effectiveness of radiation therapy limited to above the diaphragm in patients with pathological stage IA-IIA Hodgkin's disease.

* Eligble patients will receive a course of radiation therapy directed to above the diaphragm only.
* Patients would have bloodwork and chest x-rays performed 4 times per year for the first two years, 3 times per year for the third year, and 2 times per year for the fourth and fifth years. After five years, yearly check-ups are performed.
* In addition to the above follow-up, patients will receive, once or twice a year for the first 5 years, an abdominal-pelvic CT scan and/or gallium scan.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically Stage IA-IIA Hodgkin's disease
* A negative staging laparotomy including splenectomy, biopsies of liver, paraortic nodal biopsies and palpitation of upper pelvic nodes
* 18 years of age or older

Exclusion Criteria:

* Patients with large mediastinal adenopathy
* Patients with LD histology
* Patients with "B" symptoms
* Positive laparotomy
* Subcarinal, hilar, or cardiac lymph node involvement
Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch

The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence from smoking in cigarette smokers motivated to quit.

Secondary objectives are to evaluate the clinical and biological safety of rimonabant associated with nicotine replacement therapy during a 9-week treatment period and to evaluate the effect of the combination on weight and craving.


Eligibility Criteria:
Inclusion Criteria:

* Smokers smoking at least 15 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* non tobacco cigarettes consumption
* chronic use of marijuana
* pregnancy
* breastfeeding
* any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change
Infraclavicular Block Properties in Diabetic Patients

Background and objectives: The investigators are performing this study to explore whether the presence of diabetes mellitus (DM) will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm and hand surgery.

The primary hypothesis is that the sensory block duration will be delaying in diabetic patients.

Methods: Ethics committee approval has been obtained and after written informed consents, 60 patients are planning to be enrolled to the study. Diabetic patients will be included in Group DM and non-diabetics are included in Group NODM. All patients will receive ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Our primary outcome is sensory block duration, and secondary outcomes are sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS)

≥4), postoperative NRS scores and rescue analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes will be assessed by blind investigators.

Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve blocks need to be investigated on human models, besides animal researches. The investigators have been performing this study to explore whether the presence of DM will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm, and hand surgery. The primary hypothesis is that the sensory block duration will be delaying in diabetic patients.

Methods: After obtaining ethics committee approval and written informed consent, 60 patients with American Society of Anesthesiologists (ASA) physical status I-IV and aged between 40 and 80 years are enrolled to the study. Diabetic patients will be included in Group DM and non-diabetics will be included in Group NODM. All patients will receive ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Postoperatively, patients will be administered diclomec SR 75 mg IM first and if still needed tramadol 100 mg IV as rescue analgesics (numeric rating scale (NRS) is ≥4). Our primary outcome is sensory block duration, and secondary outcomes are sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores, and rescue analgesic consumption through the postoperative first 2 days. All outcomes will be assessed by blind investigators.

Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for arm, elbow, forearm, and hand surgery American Society of Anesthesiologists (ASA) physical status I-IV No regional anesthesia contraindication

Exclusion Criteria:

Type 1 DM, Type 2 DM patients with only 'diet-controlled' therapy Difficulty with understanding the block and follow-up instructions Significant neurologic disorders Psychiatric or cognitive disorders History of substance abuse Acute and/or chronic opioid use Local anaesthetic hypersensitivity or allergy