cyrilzakka/clinical-trials huggingface dataset:
Glucagon-like Peptide-1 in Type 1 Diabetes

The hypotheses to be tested in this application is: GLP-1 will acutely protect arterial endothelial function and reduce pro-atherothrombotic and pro-coagulant effects of repeated hypoglycemia in T1DM.

The naturally occurring hormone GLP-1 when co-administered during hypoglycemia (low blood sugar) in non-diabetic individuals can reduce the deleterious effects of hypoglycemia on the vasculature. We have shown that IV infusion of GLP-1 during a single moderate episode of hypoglycemia can preserve endothelial function and protect the vasculature from pro-coagulant and pro-inflammatory effects in healthy individuals.

It is unknown whether GLP-1 could protect the vasculature during episodes of repeated hypoglycemia and whether GLP-1 would have protective effects in T1DM individuals.

Eligibility Criteria:
Inclusion Criteria:

* 40 (20 males, 20 females) individuals with type 1 diabetes aged 18-50 yr.
* HbA1c \< 11.0%
* Body mass index \< 40kg • m-2
* No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)

Exclusion Criteria:

* Subjects unable to give voluntary informed consent
* Pregnancy
* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
* Subjects taking any of the following medications will be excluded: non-selective beta blockers,
* sedative-hypnotics, anticonvulsants, antiparkinsonian drugs, antipsychotics, antidepressants,
* mood stabilizers, CNS stimulants, opioids, hallucinogens
* Subjects unwillingness or inability to comply with approved contraception measures
* Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
* Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.
* Pneumonia
* Hepatic failure /jaundice
* Abnormal results following screening tests and physical examination that are clinically significant
* Acute cerebrovascular/ neurological deficit
* Fever greater than 38.0 C
* Screening Laboratory Tests Exclusion Criteria
* Hematocrit lower than 32
* WBC lower than 3 thou/ul or greater than 14 thou/ul
* Liver function tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. \> 80 U/L)
* TBil \> 2 mg/dl
* Creatinine \> 1.6 mg/dl
* Alkaline phosphatase \> 150U/L
* Hepatic transaminase \> 2x normal
Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer

This is a prospective, single-center, non-randomized, non-controlled study

Immunotherapy with immune-checkpoint inhibitors (ICIs) has enabled a leap forward in the treatment of various types of cancer within the past decade. However,only 12.46% of patients with cancer are expected to respond to ICIs.Our team have recently developed a multi-specific antibody technology platform for the microenvironment of solid tumors.

In this study, we are going to study the tumor immune microenvironment of breast cancer patients by patient-derived organoids or PDX model，to design multi-specific antibody drugs for different tumor immune microenvironment，to look forward to improve the effectiveness of immunotherapy for breast cancer and solve the problem of drug resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Women between 18 and 70 years old；
2. Primary lesion \>2cm on imaging examination, or suspected axillary lymph node metastasis on imaging examination；
3. Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments；
4. Subjects signed informed consent；

Exclusion Criteria:

1. A history of prior or concomitant malignancies;
2. Advanced stage breast cancer (stage IV)；
3. Suspected or confirmed lesion was surgically removed；
4. Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；
Guided Surgery Versus Sinus Graft

The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and more
* sinus lift
* enough remaining bone for image guided implant placement

Exclusion Criteria:

* pregnancy
* chronic disease
Mediterranean Diet Interventions for Eating Behavior and Cognitive Performance Among Older Adults in the Community

The object is to investigate the effects of a modified Mediterranean diet learning intervention program with a Mini-flipped game strategy on dietary behavior and cognitive function of elderly people in the community. The six communities were randomly assigned to the experimental group and the control group. The intervention group will last for 8 weeks. An eight-week Mediterranean diet learning program applying mini-flipped game-based learning strategies could improve dietary behavior and global cognitive function among elderly people living in the general community.

Background：The world is facing an aging population, with an increase in the number of people with mild cognitive impairment and dementia, creating a huge burden of medical costs for individuals, families, and society. Previous studies have shown that the Mediterranean Diet delays cognitive decline, but older adults are less likely to follow the Mediterranean Diet and have less knowledge about the risk of dementia and protective factors of the diet. This study will integrate the Asian version of the Mediterranean Diet Pyramid and local ingredients from Taiwan to design a nutritional health education and game intervention for the Mediterranean Diet.

Purposes：To investigate the effectiveness of developing a Mini-flipped Game-based Learning strategy to promote dietary behavior and cognitive function in the community elderly with a modified diet learning intervention.

Methods：This study was a cluster-randomized controlled trial. The six communities were randomly assigned to the experimental group and the control group.The intervention group completed an eight-week, mini-flipped, game-based learning program reinforcing compliance with the Mediterranean diet, consisting of one 40-minute session per week. The control group members maintained their usual daily diet and were given a booklet on nutrition and health. All participants will be assessed at baseline(0 weeks) and post-test(8 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and older
* No visual, hearing, or mental impairment, and could speak Mandarin.
* Are willing to participate in the study and fill out the volunteer consent form.

Exclusion Criteria:

* Diagnosis of cognitive dysfunction, brain injury with loss of consciousness for more than 30 minutes, or other central nervous system disorders. The presence of impaired sensory problems.
* Severe illnesses such as heart, liver, and lung failure, end-stage renal disease, total paralysis, terminal cancer or chemotherapy, and a diagnosis of mental illness
Observational Study on Quality of Life of Patients Receiving Nab-paclitaxel/Gemcitabine First Line Therapy, Including a Translational Program

Current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine vs. gemcitabine mono therapy, but no data are available yet on the quality of life (QoL) under this combination therapy. In the framework of a German multicenter prospective, observational study ('QoliXane'), detailed QoL-data are now collected. QoL development under treatment will be analyzed and data will be compared to existing data of the gemcitabine mono therapy.

QoL and course of therapy are collected using the EORTC C30 questionnaires once a month over a 6-month period. Additionally patients are requested to answer a supplementary questionnaire addressing e.g. fears related to QoL deterioration and side effects of chemotherapy. Primary endpoint is the proportion of patients with maintained Global Health Status/QoL at 3 months (10 points threshold). 600 patients shall be enrolled at about 90 study sites in Germany.


Eligibility Criteria:
Inclusion Criteria:

* metastatic pancreatic carcinoma
* no previous therapy in the metastatic stage
* planned firstline therapy with nab-paclitaxel and gemcitabine

Exclusion Criteria:

* previous therapy in the metastatic stage
* patient unable to understand the study and to give informed consent
* patient unable to answer quality of life questionnaires
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility

The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 20% at screening
* Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening
* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
* Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at screening and baseline ≥ 1.5 points

Exclusion Criteria:

* History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
* History of allergic bronchopulmonary aspergillosis
* Respiratory infection within 4 weeks of screening or 1 week of baseline visit
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
* Subject has previously used any anti-interleukin-17 (IL17) biologic therapy
* Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
* Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
* Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
* Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
Hydroxychloroquine Efficacy in Chronic Urticaria

This study is for those people with difficult to treat hives. We are investigating whether or not a different medication, hydroxychloroquine, works to treat a certain type of hives. Hydrochloroquine is currently approved by the Food and Drug Administration (FDA), for treating arthritis, therefore it is considered investigational in this study.

Hypothesis: Hydroxychloroquine will prove to have an efficacious response in terms of Urticarial Symptoms, on patients with chronic urticaria.

Our research question is: Is hydroxychloroquine an efficacious medicine to use in patients with chronic urticaria? Answering this question should help allergists treat chronic urticaria with a more evidence based approach. To date there has one been one prospective trial evaluating hydroxychloroquine in hives, and although it showed a trend towards efficacy (0.05\<p\<0.10), it was not statistically significant. There have been case series, and anecdotal reports which seem to demonstrate efficacy of chloroquine in chronic urticaria. Because of these reports hydroxychloroquine is often the first medication used in patients with chronic hives that are refractory to standard therapy of antihistamines. We believe an evidence based answer to this question will be an important step towards improved treatment of this disease.

We plan to ascertain the efficacy of hydroxychloroquine by completing a randomized double blinded placebo controlled study of treatment in patients with chronic urticaria. We will be measuring an Urticarial Score to evaluate hive symptoms. We will be measuring them at baseline, and at the end of the study to note change in drug vs placebo.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion:

  1. Age \>18, Age\<65
  2. Chronic Urticaria refractory to treatment with standard anti-histamines
  3. Minimum Urticaria Score

Exclusion Criteria:

* Exclusion:

  1. Pregnancy
  2. Vasculitis
  3. Trigger Induced Urticaria
  4. Food intolerance
  5. Malignancy
  6. Kidney or liver dysfunction
  7. Systemic diseases
  8. Hypersensitivity to hydroxychloroquine
Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines

This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe glabellar frown lines
* Female or male, 30 to 65 years of age in good general health
* Women of childbearing potential must agree to use an effective method of birth control during the course of the study
* Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
* Muscle weakness or paralysis, particularly in the treatment area
* Active skin disease or infections or irritation at the treatment area
* Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
* Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body
Korean Post-marketing Surveillance for Orencia®

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.

Time Perspective: Prospective / Retrospective(On-treatment)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA

Or

* Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA

Exclusion Criteria:

* Children aged \<6 years
* Pregnant or lactating women
* Patients who are participating in another study
* Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug
* Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study
* Patients who have a positive hepatitis virus test
* Patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug
Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

This study will evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis.

This is a double-blind, placebo-controlled, research study to evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis. Patients will be randomized (assigned by chance like the toss of a coin) to receive 75 mg OP2000, 125 mg OP2000, or placebo once daily for 6 weeks. Study drug will be administered by subcutaneous (under the skin) injection and patients will be taught how to self-administer these injections. Following an initial Screening Visit, eligible patients will return to the clinic for initiation of study treatment and then again for follow-up visits after 1, 2, 4 and 6 weeks of treatment. A follow-up telephone call will be scheduled 2 months (and possibly also 4 and 6 months) after completing study treatment. Study procedures will include a flexible sigmoidoscopy at the Screening Visit and at the Week 6 visit.

Eligibility Criteria:
Inclusion Criteria:

* History of ulcerative colitis at least 3 months with biopsy and colonoscopy confirmation.
* Treatment with aminosalicylates at least 28 days, if tolerated.
* Duration of current flare-up at least 7 days.
* Must be able to self administer once-daily subcutaneous (under the skin) injections of study drug.

Exclusion Criteria:

* Disease limited to the rectum.
* Toxic megacolon.
* The use of anticoagulant drugs.
* A history of any bleeding disorder.
* A history of heparin-induced thrombocytopenia.
* Evidence of liver or kidney impairment.
* Women who are pregnant or breast feeding.
Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway

This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups.

The purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class II.

Eligibility Criteria:
Inclusion Criteria:

1. Skeletal class II division 1 malocclusion due to mandibular retrognathism.
2. Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥ 4.
3. Overjet ≥ 6 mm.
4. Patient in circumpubertal stage CVM2 and CVM3.

Exclusion Criteria:

1. History of orthodontic treatment.
2. Presence of craniofacial anomalies or TMJ disorders.
3. Systemic problems that may affect craniofacial growth.
4. Abnormal oral habits.
Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B in the Rural Area of Niakhar, Senegal

This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both health-related and socio-economic consequences.

The prevalence of chronic HBV infection in Senegal is among the highest worldwide (10% to 17%) but available prevalence estimates relie on studies conducted in specific subgroups (such as military, pregnant women or blood donors).

The prevalence of HBV chronic infection remains undocumented in the general population of Senegal, and its health-related and socio-economic consequences need to be estimated.

This research is based on a cross-sectional survey conducted in the general population with collection of biological, socio-behavioral and economic data at two levels (at the participants' home and in healthcare centers) in the area of Niakhar (located at 135 kms at the East of Dakar).

The research includes three phases as follows:

(i) Preliminary phase: information and communication about the research within the community, training of stakeholders and pilot survey

(ii) Collection of data in the general population

(iii) Communication of results on HBV status to participants and collection of additional data among HBV chronic individuals

Eligibility Criteria:
Inclusion Criteria:

(i) Living in a household of the research zone (individuals living within participating households for at least 6 months, even non permanently: seasonal workers or individuals studying outside the Niakhar zone)

(ii) Being aged of at least 6 months

(iii) Giving informed consent to participate in the research

Exclusion Criteria:

(i) Being an adult unable to sign informed consent

(ii) Being a child whose parents or legal guardian is not present in the household at the time of the survey
Dexmedetomidine vs Fentanyl in Controlling Labor Pain

As most woman experience agonizing pain throughout vaginal labor. Adjuvants were added to intrathecal bupivacaine aiming to improve the quality of analgesia. This study aimed to assess the efficacy and outcome of intrathecal dexmedetomidine and fentanyl in controlling pain during delivery.

Throughout vaginal deliveries, many women suffered from pain. providing suitable analgesia is crucial (Lupu et al., 2023). Spinal anesthesia can provide pain management (Parikh et al., 2018).

Various types of analgesics can be combined to get the needed duration of perioperative analgesia. Dexmedetomidine has been used with effective pain management outcomes (Shrestha et al., 2023). Fentanyl can help pain relief in short duration procedures (Show et al., 2022).

Eligibility Criteria:
Inclusion Criteria:

* women planned for spontaneous vaginal delivery.

Exclusion Criteria:

* cardiac, liver or kidney disease, allergy to local anesthetics or the studied drugs, any contraindication of regional anesthesia and intrauterine growth retardation or fetal compromise.
DURABILITY™ Iliac Study

The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries.


Eligibility Criteria:
Inclusion Criteria:

* Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
* Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
* Willing to comply with all follow-up evaluations at the specified times.
* Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

* Previous implantation of stent(s) in the target vessel.
* Received endovascular treatment of the target lesion within six months prior to the index procedure.
* Known hypersensitivity to contrast material that cannot be adequately pretreated.
* Known hypersensitivity to nickel-titanium.
* Life expectancy of less than 12 months