cyrilzakka/clinical-trials huggingface dataset:
Energy Specific Far Infrared Radiation Treatment for AIDS

The investigators are proposing that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of killer cells to fight and destroy the human immunodeficiency virus.

Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (AIDS or Aids) is a collection of symptoms and infections resulting from the specific damage to the immune system caused by the human immunodeficiency virus (HIV) in humans. The late stage of the condition leaves individuals prone to opportunistic infections and tumors. Although treatments for AIDS and HIV exist to slow the virus' progression, there is no known cure.

The investigators are postulating that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of CD4+ T cells and other killer cells to fight and destroy the human immunodeficiency virus.

The primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 20μm wavelength) on HIV/AIDS.

Eligibility Criteria:
Inclusion Criteria:

* 1 Year and above

Exclusion Criteria:

* None
Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Gastrointestinal Cancer

This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) combined with immune cells (IC01) in subjects with advanced Gastrointestinal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form must be obtained prior to any research procedures;
2. Age: 18 Years to 70 Years;
3. The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (200 ml) for the treatment, and who signs the informed consent form independently;
4. Histologically confirmed diagnosis of gastrointestinal cancer;
5. Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
6. Karnofsky Performance Status (KPS) score ≥ 70
7. Expected survival ≥ 3 months
8. Adequate organ function defined as: ANC≥3.5×10\^9/L, PLT≥50×10\^9/L, ALB≥25g/L, AST≤2.5×ULN, ALT≤2.5×ULN, TBIL≤1.5×ULN
9. If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result.

Exclusion Criteria:

1. Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment;
2. Patients who have not recovered from adverse reactions related to above-mentioned procedures;
3. Patients with two types of primary solid tumors;
4. Patients with brain metastases or bone metastases;
5. Patients with poorly controlled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association Class II or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on treatment;
6. Patients with other serious organic diseases or mental disorders;
7. Patients with systemic or active infection;
8. Patients with positive HIV test result;
9. Patients who have received an organ transplant;
10. Patients who are breastfeeding or pregnant.
Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

Objective: To investigate the incidence of lateral neck node occult metastasis and to show the usefulness of sentinel lymph node biopsy (SLNB) in the detection of lateral neck node metastasis in thyroid carcinoma, the investigators used a radioisotope to detect the sentinel lymph node.

Summary Background Data: Although occult lymph node metastasis to the lateral neck compartment is common in papillary thyroid carcinoma, the incidence and patterns of lateral neck node metastasis in papillary carcinoma are not known.

On the day of the operation, patients underwent preoperative lymphoscintigraphy after the intratumoral injection of a Tc-99m phytate 1 mCi in 0.1-0.2 mL 0.9% NaCl under ultrasonographic guidance. Total thyroidectomy or lobectomy with central neck dissection preceded SLN detection to avoid interference by primary tumor radioactivity. After total thyroidectomy or lobectomy, the dissections were performed toward the internal jugular chain beneath the sternocleidomastoid muscle. A handheld, collimated gamma probe and lymphoscintigraphy were used to scan the lateral compartments (through skin and under the SCM) for "radioactive" lymph nodes. Removed SLNs were submitted immediately for frozen biopsy. If any of the SLNs were positive for metastasis on the frozen sections, MRND was performed immediately. In cases for which the frozen section was negative but the final pathology report detailed microscopic positivity in the lateral sentinel nodes, RAI ablations were performed without additional MRND.

Eligibility Criteria:
Inclusion Criteria:

* Cases with tumors larger than 1 cm in size or with suspicious central neck node metastasis in Papillary thyroid cancer

Exclusion Criteria:

* The patient with definite metastatic lymph node in lateral neck compartment
Anatomical Right Posterior Sectionectomy of the Liver by IOUS-Guided Finger Compression

The use of intraoperative ultrasound (IOUS) allows us to perform new conservative hepatectomies. The investigators previously reported the systematic subsegmentectomy by IOUS-guided finger compression for segments 2-3, which is currently applied for patients with hepatocellular carcinoma (HCC)on cirrhosis. The investigators herein describe a novel technique, which consists in the systematic right posterior sectionectomy by IOUS-guided finger compression.

A novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to accomplish a right posterior sectionectomy is described. Dissection or encirclement of the sectional pedicles for resection area demarcation is thus avoided. Ten patients underwent this technique successfully without mortality or major morbidity. IOUS-guided finger compression of sectional portal pedicle feeding the right posterior section is a feasible, safe, and effective method.

Eligibility Criteria:
Inclusion Criteria:

* Patients with tumors at least at 1 cm distally to the bifurcation of the right portal vein (bifurcation of P5-8 and P6-7) eligible for right posterior sectionectomy, namely the anatomical removal of segment 6 and 7, were considered potential candidates to this procedure. Precisely, these criteria were adopted:

  * Patients with hepatocellular carcinoma (HCC) with infiltrative growing pattern in contact with P6-7;
  * Patients with any type of HCC in contact with P6-7 with distal bile duct dilation;
  * Patients with colorectal liver metastasis (CLM) in contact with P6-7.

Exclusion Criteria:

* Exclusion criteria for carrying out the herein described procedure was considered the presence of tumoral thrombosis in P6-7.
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms


Eligibility Criteria:
Inclusion Criteria:

* The patient has recurrent Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual for Mental Disorders, 5th Edition (DSM-5™), classification code (296.3x). The recurrent Major Depressive Episode (MDE) should be confirmed using the Mini-International Neuropsychiatric Interview (MINI).
* The patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥30 at both Screening and Baseline Visits.
* The patient has had the current MDE for ≥3 months

Exclusion Criteria:

* The patient has any current psychiatric disorder or Axis I disorder (DSM-5™ criteria), other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI).
* The patient has a current diagnosis of history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-5™ criteria).
* The patient suffers from personality disorders, intellectual disability, pervasive development disorder, attention deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-5™ criteria).
* The patient has a history of lack of response to previous treatment with vortioxetine (including current episode).

Other Protocol defined inclusion and exclusion criteria may apply
Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Age range 20 to 54 years, Body mass index of ≥19 and ≤26 healthy male volunteers
2. Able to participate in all procedure
3. SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min
4. Have given written informed consent

Exclusion Criteria:

1. Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease
2. Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia)
3. Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics)
4. Have history of drug abuse. A positive test for any drug(amphetamine, barbiturates, cocaine, opiates, benzodiazepines, THC, methadone, ect.) included in the urine drug screen.
5. Have herbal drug within 30days prior to the first IP administration, have ETC within 14days prior to the first IP administration, have OTC 7days prior to the first IP administration.
6. Have diet which may influence on the absorption, distribution, metabolism or excretion of drug(s), (Drinking over 1L of grapefruit juice within 7days prior to the first IP administration)
7. Have received an investigational drug within 60 days prior to the first IP administration
8. Have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first IP administration
9. Have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first IP administration.
10. A heavy caffeine/alcohol consumer or a heavy smoker(caffeine \> 5 units/days. alcohol \>21 units/week (1 unit=pure alcohol 10mL), Cigarette \> 10 Cigarettes/day) or alcohol abuse.
11. Positive for Hepatitis B, Hepatitis C, HIV or syphilis
The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs

Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies, the impact of these new kinds of insulin pumps on glycemic control and patient-reported outcomes (PROMs) is still unclear. Therefore, this study will evaluate the impact of the Medtronic MiniMed 670G, Medtronic MiniMed 780G and Tandem Control-IQ systems on glycemic control and PROMs in people living with type 1 diabetes under real-life conditions. In a multicenter real-world observational study, 350 adults and 100 children with type 1 diabetes who are treated with each of these systems in one of 17 Belgian centers, will be followed for a period of 24 months. The primary endpoint is the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dL) from before start to 12 months after start of hybrid closed-loop therapy.

Since not much is known about the impact of hybrid closed-loop on partners of adults living with type 1 diabetes, an optional substudy (INRANGE-PARTNER) will be performed investigating the quality of life in partners of adults of type 1 diabetes using hybrid closed-loop therapy. More specifically, the substudy will compare the quality of life of partners of type 1 diabetes patients both before and after implementation of hybrid closed-loop therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients with type 1 diabetes
* patients aged 6 years or older
* patients starting with hybrid closed-loop therapy (as part of routine clinical practice) in one of the 17 participating centers. Note: the decision about which patient to start, is left to the clinical judgement of the treating health care professional.
* patients who signed informed consent

Exclusion Criteria:

* patients without type 1 diabetes
* patients under 6 years of age
* patients not starting with hybrid closed-loop therapy in one of the 17 participating centers
* patients who did not sign informed consent
Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.

The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
2. Hill's grade II and III of the gastroesophageal junction
3. One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH \< 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of \< 6mmHg or total length of less than 4cm or abdominal length of less than 2cm

Exclusion Criteria:

1. Age \> 70 yrs of \< 18 yrs
2. Pregnancy
3. Any type of Hiatus hernia
4. Patients with underlying malignancy
5. ASA above grade III
A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma

This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma.

This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study. The purpose of this study is to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma and not adequately controlled with current stable medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers.Subjects will be randomized to receive AK120 or placebo subcutaneous injection.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female subjects aged ≥18 years old and ≤75 years old;
2. Asthma was diagnosed ≥ 12 months before screening, current stable treatment with medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers ≥ 3 months;
3. Blood eosinophil≥ 200 cells per microliter within 6 months before screening;
4. During the screening, 40% of the predicted normal value \< pre-bronchodilator FEV1 \< 80% of the predicted normal value, within 12 months before randomization, reversible airflow restriction was recorded;
5. Asthma was inadequately controlled;
6. For women with childbearing potential, they are not pregnant or lactating, and the subjects and their partners voluntarily take effective contraceptive measures judged by the investigators during the treatment and at least 3 months after last dose.

Key Exclusion Criteria:

1. Subjects with lung diseases other than asthma, which may affect the subject's health or end point evaluation of the study;
2. Subjects had severe exacerbation events or systemic glucocorticoids usage within 1 month before randomization;
3. Respiratory tract infection and any serious infection within 1 month before randomization;
4. Subjects with parasitic infection, active tuberculosis infection, Hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis positive confirmation test;
5. Known or suspected history of immunosuppression;
6. History of malignant tumors;
7. A history of smoking: those who had quit smoking for ≤ 6 months before screening, or smoking history \> 10 pack per year;
8. Previous treatment with interleukin-4 (IL-4) or interleukin-13 (IL-13) inhibitors, and inadequate washout period of other biologic therapy;
9. Allergen immunotherapy within 3 months before randomization;
10. Progressive or uncontrolled other diseases or any other conditions or abnormal laboratory tests for which the investigator assess that the subjects are not suitable to enrol in the study.
Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder

Premenstrual Dysphoric Disorder (PMDD) is a severe form of premenstrual syndrome (PMS) affecting up to 8% of reproductive age women. It is characterized by physical and psychological symptoms that occur in the luteal phase of the menstrual cycle, prior to the onset of menses, and leads to negative impact on the psychosocial functioning of affected individuals.

Selective serotonin reuptake inhibitors are usually used to treat PMDD but they have several side effects so it is important to use complementary treatment such as tryptophan-rich diet and acupuncture for women with PMDD . The purpose of the current study is to determine the combined effect of tryptophan-rich diet and acupuncture on depression related to premenstrual dysphoric disorder

This study will be conducted on 39 participants suffering from premenstrual dysphoric disorder (PMDD). They will be recruited from Horus University, New Damietta, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* All females will be clinically diagnosed with premenstrual dysphoric disorder (PMDD) as confirmed and referred from the gynaecologist.
* All females will be firstly assessed by Hamilton Depression rating scale (HDRS) for two months to confirm depression related to PMDD before participating in the study.
* Their ages will be ranged from 20 to 30 years.
* Their BMI will be ranged from 20 to 25 kg/m.
* Being virgin.
* Having regular menstruation for the last 6 months (every 28- 35 days with no intermittent bleeding).
* All females have a sedentary lifestyle.
* Voluntary acceptance of participation in the study

Exclusion Criteria:

* Using hormonal contraception (such as oral contraceptives and injections).
* Menstrual irregularity.
* Using diuretics or psychiatric medications.
* Using chronic non-steroidal anti-inflammatory drugs.
* Pre-diagnosed with any other psychological problems not related to PMDD.
* Follow any exercise programs.
Diabetic Care Self-Management Mobile Health Application Among Diabetes Mellitus Clients in Malaysia

The main purpose of this study is to explore the effect of Diabetic Care Self-Management Mobile Health Application in behavioral modification i.e foot care behaviour and dietary behaviour among diabetic clients in Malaysia. Diabetic Care Self-Management Mobile Health Application is a mobile health (mHealth) application program aiming for primary care in health prevention and promotion activity. The program is developed by the researcher through the literature review conducted. The program is evaluated through a randomized controlled trial study design.


Eligibility Criteria:
Inclusion Criteria:

* Past readings of A1c more than 6.5% (Ministry of Health Malaysia, 2015).
* Has at least Stage 1 or above for the risk of foot ulcer development. The risk will be identified through diabetic foot screening. The screening will be carried out by using Inlow's 60 Second Diabetic Foot Screen.
* Age of 18 to 65 years old. Since the study is using mobile health applications, technology literate is an important factor to see the effect of mHealth on behaviour modification process. If the patient is more than 65 years old, the patient might have some difficulties in using mobile health intervention. Meanwhile, for the patient less than 18 years old, guardian permission is required prior to study enrolment.
* Have no history of diabetic foot ulcers.
* Able to independently perform self-care.
* Able to use a mobile application program.
* Own an android phone.
* No vision or hearing problem may interfere with the process of data collection and intervention carried out.
* Able to communicate in either English or Bahasa Malaysia (a native and official language of the country)

Exclusion Criteria:

* The patient that did not come for the follow-up care at Week 5. For instance, the patient may have other matters on the day of follow-up up which required their urgent attention and not able to come for the follow-up, or is stay outside of the area during the day of follow up.
* Have difficulty in performing foot care during in the middle of the intervention period. For example, the client may get sick due to hypoglycemic or hyperglycemic attack which stopped them from being able to perform the foot care behaviour.
* The patient is diagnosed with any cognitive and perceptual decline function
A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer

To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;
* Karnofsky performance status≥70 and measurable or evaluable;
* Stages Ⅲa-ⅢC;
* Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
* Adequate marrow function (WBC count\> 4.0×10(9)/L, neutrophil\> 2.0×10(9)/L, platelet count \> 100×10(9)/L，hemoglobin \> 90g/L );
* AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase
* ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;
* Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;
* Expected lifetime ≥ 12 months;
* Pregnancy tests of reproductive age women is negative;
* All patients provided written informed consent.

Exclusion Criteria:

* Distant metastasis;
* Severe heart failure (NYHA grade II or higher);
* Active and uncontrolled severe infection;
* Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
* Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;
* Pregnancy or breast feeding;
* Other situations that investigators consider as contra-indication for this study
Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction (STEMI)

The goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. We included 652 patients who presenting a STEMI from september 2017 to october 2020 and manage by physician in prehospital and bring to CHU of Dijon.

We analyse and compare the caracteristics of a group of STEMI patients who presenting an arrythmia to an other groupe of STEMI patient without arrythmia


Eligibility Criteria:
Inclusion Criteria:

\> 18 years old, with STEMI, in prehospital patient, take by a medecine, bring to the CHU Dijon

Exclusion Criteria:

\< 18 years old, without STEMI, no medical in prehospital