cyrilzakka/clinical-trials huggingface dataset:
Ghrelin and Beta Cell Function in Diabetes

Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this research study is to determine the role of this gut hormone in the regulation of insulin secretion from the pancreas and glucose disposal after we eat. The investigators hypothesize that ghrelin has an effect on the pancreas and on how our body handles glucose after we eat. The investigators will compare insulin secretion and glucose changes during meal ingestion while either acyl ghrelin (AG) or saline (salt solution) is being infused through your vein on separate study days. AG is a form of the ghrelin hormone that has a small modification to it that allows it to bind to a specific receptor. The investigators hypothesize that AG has an effect on how the body handles glucose after a meal. AG has been approved by the U.S. Food and Drug Administration (FDA) for human research only. This study will also involve the use of a medicine called arginine, which is a naturally occurring product and found in many nutritional supplements. Its use in this study is investigational. The use of arginine helps maximize insulin release from the pancreas so the investigators can better examine whether AG affects insulin secretion.


Eligibility Criteria:
Inclusion Criteria:

T2DM study subjects to be considered for the study must meet the following inclusion criteria:

1. Established T2DM with good to moderate glycemic control
2. HbA1c \< 8.5%
3. Diabetes treatment with metformin, sulfonylurea, thiazolidinediones or combination of these medications; with no use of insulin during the study period
4. BMI ≤ 45.0 kg/m2

Control study subjects will be matched for age- (± 2 years), BMI (± 1.5 kg/m2) and gender and must meet the following inclusion criteria:

1. HbA1c ≤ 5.7%
2. Fasting plasma glucose ≤ 95 mg/dL
3. BMI ≤ 45.0 kg/m2

Exclusion Criteria:

All subjects will be excluded for the following reasons:

1. History of myocardial infarction or arrhythmia within the past year, abnormal electrocardiogram (ECG) with evidence of ischemia or arrhythmia, history or symptoms of congestive heart failure
2. Uncontrolled hypertension
3. History or active liver or renal disease (AST or ALT \>2x upper limits of normal, calculated glomerular filtration rate \[eGFR\] \<60 at screening)
4. History of pituitary or adrenal disorders or neuroendocrine tumor
5. Anemia defined as hematocrit \<33% at screening
6. Active cancer diagnosis or currently undergoing cancer treatment
7. History of anorexia nervosa or previous gastrointestinal tract surgery
8. Pregnancy or lactation

Control subjects will be excluded for the following reasons:

1. History or clinical evidence of impaired fasting glucose or impaired glucose tolerance on a 75 g OGTT, established diabetes mellitus, or taking medications prescribed for diabetes
2. Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids, metformin)
Primary Tube Versus Trabeculectomy Study

The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years
* Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
* No previous incisional ocular surgery

Exclusion Criteria:

* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
* Pregnant or nursing women
* No light perception vision
* Active iris neovascularization or active proliferative retinopathy
* Iridocorneal endothelial syndrome
* Epithelial or fibrous ingrowth
* Chronic or recurrent uveitis
* Steroid-induced glaucoma
* Severe posterior blepharitis
* Unwilling to discontinue contact lens use after surgery
* Previous cyclodestructive procedure
* Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a superior trabeculectomy
* Functionally significant cataract
* Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery
POLARx Post Approval Study (POLARx PAS)

To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillation (AF).


Eligibility Criteria:
Inclusion Criteria:

* Subjects indicated for drug refractory, recurrent symptomatic PAF treatment with the Cryoablation System, per physician's medical judgement, and as per standard of care
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;

Exclusion Criteria:

* Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU as legally approved conditions;
* Any prior LA ablation;
* Known or pre-existing severe PV Stenosis;
* Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
* Presence of any pulmonary vein stents;
* Subjects with active systemic infection;
* Subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma

This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Partially controlled mild-moderate atopic asthma
* Receiving inhaled corticosteroids
* Non-smoker or former smoker
* Males and females aged 18 to 55 years inclusive
* If female, must be of non-childbearing potential

Exclusion Criteria:

* History of acute severe asthma attacks
* History of COPD
* Other serious respiratory or other medical condition which may interfere with the outcome of the study
Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis

The purpose of this study is to evaluate the effectiveness and safety of 2.5, 5 and 10 mg doses of mifepristone against a placebo in women with laparoscopic diagnostic of endometriosis.

The hypothesis of the study is that the 5 mg mifepristone dose is safe and effective and should be used in future studies on medical treatment of endometriosis.

This is double-blind randomized clinical trial.

Examinations undertaken Thorough gynecological examination, pelvic ultrasound examination, diagnostic laparoscopy before starting treatment in order to determine the localization, extent and degree of severity of the endometrial lesions and a score was assigned in accordance with the revised American Fertility Society (AFS) classification.19 Blood samples were taken for hematological tests and hepatic function. Endometrial biopsy was performed if endometrial thickness as calibrated by ultrasound was \>8 mm or if there had been abnormal bleeding in the past 3 months. After 90 and 180 days of treatment an ultrasound examination of the pelvis was carried out and then followed by diagnostic-therapeutic laparoscopy and endometrial biopsy.

Subjects Women with laparoscopic confirmed diagnosis of endometriosis who volunteered to take part in the study. Inclusion criteria: a) age between 18 and 45, b) certain diagnosis of endometriosis of any degree corresponding to the American Fertility Society (AFS); c) patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to other gynecological illness and d) acceptance of the use of barrier contraceptive methods during the study. Exclusion criteria: a) breastfeeding, b) hormonal or surgical treatment for the endometriosis less than 4 months previous to study, c) diabetes, d) severe arterial hypertension, e) hepatopathy, f) renal malfunction, g) endocrinopathy, and f) any other contraindication regarding the use of antiprogestins.

Eligibility Criteria:
Inclusion Criteria:

* Women with laparoscopic confirmed diagnosis of endometriosis
* Age between 18 and 45
* Certain diagnosis of endometriosis of any degree corresponding to the American Fertility Society (AFS)
* Patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to other gynecological illness and
* Acceptance of the use of barrier contraceptive methods during the study

Exclusion Criteria:

* Breastfeeding
* Hormonal or surgical treatment for the endometriosis less than 4 months previous to study
* Diabetes
* Severe arterial hypertension
* Hepatopathy
* Renal malfunction
* Endocrinopathy
* Any other contraindication regarding the use of antiprogestins.
Stuttering and Anxiety

Stuttering was defined as a common neurodevelopmental speech disorder characterized by repetitions, prolongations, and interruptions in the flow of speech. In other words, stuttering is a speech disorder characterized by involuntary disruptions to speech which impede the capacity to communicate effectively.

Physiological and emotional anxiety has been reported in persons who stutter. It has been reported that as high as 44% of clients seeking treatment for stuttering could be assigned a co-occurring social phobia or social anxiety diagnosis.

According to the Diagnostic and Statistical Manual of Mental Disorders, social anxiety disorder is characterized by marked or intense fear of social or performance-based situations where scrutiny or evaluation by others may occur. Feared situations often include speaking in public, meeting new people, and talking with authority figures.

There are several reasons to expect that stuttering may be associated with social anxiety disorder. To begin with, stuttering is accompanied by numerous negative consequences across the lifespan which may increase vulnerability to social and psychological difficulties. These consequences are intensified during the school years when children become more involved in social and speaking situations. As a result, children and adolescents who stutter frequently experience peer victimization, social isolation and rejection, and they may also be less popular than their non-stuttering peers.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 6 years to 16 years
* Gender: both sex is included in the study
* Intelligence quotient ≥ 85

Exclusion Criteria:

* Intelligence quotient \< 85
* Age below 6 years or above 16 years
* Presence of other speech, language or physical disorders
Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer

Primary objective:

- To evaluate the rate of responses to neoadjuvant therapy + radiotherapy

Secondary objective:

- tolerability (toxicity) and time to progression


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* Patients with measurable, histologically proven rectal cancer.
* No history of previous malignancy but adequately treated skin / cervical cancer.
* Adequate haematological, renal and liver function.

Exclusion Criteria:

* No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.
Spinal Cord Stimulation in Chemotherapy Induced Neuropathy

This is an observational based pilot study evaluating the use of spinal cord stimulators for the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.

Cancer treatment, for many patients, results in painful side effects. As evidence mounts demonstrating the risks associated with long term opioid therapy, non-opioid modalities need to be developed. Spinal cord stimulators are implanted devices that modulate the pain signaling system in the spinal cord. This research hopes to determine if the use of a spinal cord stimulator in patients with chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.The primary endpoints will be the number of patients who undergo permanent implantation. The endpoints will measure pain with the Brief Pain Inventory Short Form visual analog scale. The sleep quality will be measured using the Pittsburgh Sleep Quality Assessment.

Eligibility Criteria:
Inclusion Criteria:

• The patient has persistent, severe peripheral neuropathy secondary to chemotherapy

Exclusion Criteria:

• Refusal to undergo a spinal cord stimulator procedure
Molecular Diagnosis of Lung Cancer Via Bronchoscopy: The Significance of Bronchial Liquid Biopsy (ctDNA and ctRNA)

The management of lung cancer is a major public health challenge. Molecular anomaly testing is recommended from the early stages for optimal and personalized care of all lung adenocarcinomas and non-smoker lung cancers. The search for these anomalies relies on increasingly advanced and sensitive analysis techniques, particularly Next-Generation Sequencing (NGS), which can simultaneously detect various molecular abnormalities in both DNA and RNA, including point mutations, complex mutations, rearrangements, and amplifications. These techniques are predominantly performed on biopsy specimens embedded in paraffin. However, these biopsies may require invasive and sometimes iatrogenic procedures, and their feasibility, quantity, and quality of the samples can be limited. The turnaround time for analysis results from the time of biopsy is typically around 2 to 3 weeks.

In recent years, alongside the improvement in the sensitivity of molecular analysis techniques, liquid biopsy has emerged as a valuable approach, particularly in the analysis of circulating tumor DNA (ctDNA). ctDNA is a non-invasive diagnostic biomarker that has been validated for detecting targetable molecular anomalies similar to those detected by "conventional" biopsies. ctDNA can be detected in plasma through a simple blood draw, as well as in cerebrospinal fluid, urine, saliva, or any other "liquid" sample from the patient. The concordance between mutations identified in the tumor and those detected in the blood exceeds 90% specificity in numerous studies. However, the sensitivity of ctDNA detection varies depending on the stage of the disease and the sensitivity of the detection technique used.

The utility of bronchial ctDNA is currently underexplored. However, there is a rationale for investigating ctDNA as close as possible to the cancerous lesion at the bronchial level. Bronchial ctDNA could play a role in molecular diagnosis for distal lesions not visible through endoscopy and could also help reduce costs and turnaround time for molecular diagnosis in larger tumors.

The objective of this study is to evaluate the utility of liquid biopsy (ctDNA and ctRNA) during bronchoscopy in the molecular diagnosis and management of bronchial carcinomas. This is a prospective multicenter French study that will include 50 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients Referred for Bronchoscopy at TNN or PSL for Diagnostic Evaluation or Follow-up of Known or Suspected Lung Cancer.
* Age \>18 years.
* Informed, Written, and Signed Consent.
* Participants must be covered by a national health insurance scheme.

Exclusion Criteria:

* Patient Refusal
* Patient benefiting from legal protection measure
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated.

B Lymphocytes of patients with systemic sclerosis will be assessed in term of interaction with fibroblasts from patients with systemic sclerosis and compared to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

patients

* systemic sclerosis according to ACR-EULAR 2013
* written consent
* available insurance

Healthy "blood" and healthy "biopsy" controls

* written consent
* available insurance

Exclusion Criteria:

patients

* overlap with other connective tissue diseases
* immunosuppressants in the past 12 months
* corticosteroids ≥10mg/d
* pregnancy or breast feeding

Healthy "blood" and healthy "biopsy" controls

* systemic sclerosis according to ACR-EULAR 2013
* another connective tissue diseases
* immunosuppressants in the past 12 months
* corticosteroids ≥10mg/d
* pregnancy or breast feeding
* With dysimmune inflammatory diseases (except thyroiditis)
* Presenting an infection in progress or within the previous 15 days
Anlotinib in Advanced Solid Tumors With FGFR Alteration

This clinical trial aims to evaluate the efficacy, safety of Anlotinib in advanced solid tumors with FGFR alteration.


Eligibility Criteria:
Inclusion Criteria:

Patients should be histologically diagnosed with advanced solid tumors; Patients with FGFR mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;

Exclusion Criteria:

Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.
Early Cancer Detection Test - Lung Cancer China

Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. LDCT is more and more popular accepted as an effective screening methodology but leads to numerous indeterminate pulmonary nodules for physicians to distinguish too. The value of autoantibody test in risk assessing of IPNs as well as early detection of lung cancer in high risk population has been demonstrated in clinical practice and trial but mainly in Caucasian. Purpose of this study is to understand the sensitivity, specificity and accuracy of candidate autoantibodies, and consequently explore the autoantibody combination with best clinical performance in Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 or above.
* Individuals complying with either of the following

  1. diagnosed as lung cancer (histopathologically confirmed);
  2. diagnosed as benign pulmonary nodule (confirmed by pathology or by follow-up based on 2018 Chinese Consensus on Pulmonary Nodule Diagnosis and Treatment);
  3. without pulmonary nodule but with lung cancer risk factor, age \& gender matched recruited lung cancer patients.
* Participant is willing and able to provide necessary information required in CRF.
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* History of any cancer;
* Lung cancer patient who received or is receiving any treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women

The overall objective of this study is to evaluate whether the addition of secondary distribution HIV self-test kits to existing partner notification guidelines increases the proportion of male partners who access facility-based HIV testing services, when compared to the partner notification strategy alone

Pregnant women 18 years of age or older who enter antenatal care at Chipata Level 1 Hospital in Lusaka, Zambia will participate.

HIV-positive and HIV-negative pregnant women will be randomized to one of two groups: partner notification alone or partner notification plus secondary distribution of HIV self-test kits. Women will return to the clinic 30 days after enrollment for an exit visit during which time information about their experience with the partner notification strategies will be collected.

A random sample of women and health care workers will also participate in qualitative interviews.

Eligibility Criteria:
Inclusion Criteria

* 18 years of age or older
* Pregnant at time of enrollment based on antenatal record
* Documented HIV status (either positive or negative) in antenatal record
* Reports at least one current sexual partner
* Willingness to provide her own contact information
* Ability and willingness to provide informed consent
* Intent to remain in current geographical area of residence for the duration of follow-up activities
* Willingness to adhere to study procedures

Exclusion Criteria

* Women who express concerns about IPV or social harms as a result of participation during the screening process will not be included.
* Women who have previously enrolled in the study will not be permitted to enroll again.