cyrilzakka/clinical-trials huggingface dataset:
Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

Esophageal cancer is a prevalent digestive tract tumor, with around 400,000 new cases and 300,000 deaths globally each year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma (ESCC) patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate.

Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of ESCC. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect.

The results of the Phase 1b trial evaluating adbelimumab monotherapy as a neoadjuvant treatment for locally advanced resectable ESCC demonstrated that patients receiving two cycles of neoadjuvant sequential surgery exhibited favorable safety profiles, with no adverse reactions of grade 3 or higher. The trial reported a major pathological response (MPR) rate of 24%, a pathological complete response (pCR) rate of 8%, a 2-year overall survival (OS) rate of 92%, and a 2-year recurrence-free survival (RFS) rate of 100%. The effectiveness of combining adbelizumab with chemotherapy and targeted therapy for locally advanced esophageal cancer is uncertain.

This study aims to assess the efficacy and safety of using adbelizumab with chemotherapy and apatinib as neoadjuvant therapy for resectable ESCC.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Patients age 18 to 75 years old.
3. Primary resectable, histologically confirmed esophageal squamous cell cancer.
4. Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).
5. ECOG PS 0-1.
6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist.

Exclusion Criteria:

1. With significant cardiovascular disease.
2. Current treatment with anti-viral therapy or HBV.
3. Female patients who are pregnant or lactating.
4. History of malignancy within 5 years prior to screening.
5. Active or history of autoimmune disease or immune deficiency.
6. Signs of distant metastases.
Chronic Alcohol and Brain Stress Circuit Response

Alcoholism is among the top three causes of preventable death and disease in the US (Mokdad et al., 2004; Room et al., 2005). Stress plays an important role in the development of alcoholism and in high vulnerability to alcohol relapse. This study will provide a greater understanding of the mechanism by which stress and alcohol consumption interacts to influence development of compulsive alcohol seeking and vulnerability to stress-induced drinking, and the results will have significant implications for the development of new prevention and treatment interventions for alcoholism.


Eligibility Criteria:
Inclusion Criteria:

* ages 21-50
Testosterone Replacement Therapy Decreases Plasma Paraoxonase 1 Enzyme Activity In Male Patients With Hypogonadism

The purpose of this study is investigating the effect of testosterone treatment on paraoxonase level in male patients with hypogonadotrophic hypogonadism


Eligibility Criteria:
Inclusion Criteria:

* Volunteers patients with hypogonadism

Exclusion Criteria:

* Coronary heart disease
* Other pituitary/hypothalamic disorders or other non-hypogonadism diseases
* None was receiving vitamins, lipid-lowering drugs, or other medications known to interfere with PON1 activity, lipid profile, or gonadal function
The Effects of Combining Whole Body Vibration Training With Plyometric Jumping on the Neuromuscular Adaptations of Human Triceps Surae Muscles

Muscle force, explosive strength and vertical jump height are important parameters determining the performance of athletes. Traditionally, high intensity resistance training, explosive strength training and plyometric training are used to improve athletes' performance. Recently, whole body vibration training is recommended for increasing muscle force and explosive strength, because vibrating platform could provide high gravitational acceleration to activate muscle activation and sensory input to spinal reflex. Design: Prospective and randomized control study. Subjects: Healthy male subjects with regular training or competition at least 6 hours per week. Methods: H-reflex, V-wave, triceps surae activation level and rate of force development are measured at pre-training, mid-training (5th week) and post-training. Subjects will receive 8 weeks, 3 times/week, training programs including plyometric jumping or static squat on whole body vibration platform. Data analysis: Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL) and two-way ANOVA will be used for data analysis.


Eligibility Criteria:
Inclusion Criteria:

* subjects who had not been engaged in systematic strength training and had no history of knee, leg, or ankle pain that caused a subject to seek medical help during the year prior to the recruitment.

Exclusion Criteria:

* Subjects who missed more than one training session or participated in any other type of fitness training were excluded.
Aspiration Device in Myocardial Infarction Trial

Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI).

The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population.

Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.

ADMIT-Randomized Single Center Study with two arms:

Standard PCI versus Primary PCI, using thrombus aspiration device after ever step of the procedure.

Issues to be examined are:

1. Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,
2. Infarc size evaluated by serum markers and non invasive parameters
3. In hospital major adverse cardiac events
4. Major adverse cardiac events during 30\& 180 days of follow up

Eligibility Criteria:
Inclusion Criteria:

* patients with STEMI\<12 from synptoms onset
* eligble for primary PCI regardless of initial TIMI flow grade.
* patients for rescue PCI after failed thrombolysis will also be included

Exclusion Criteria:

* womwn with known pregnancy or who are lactating
* pts with allergy to aspirin, clopidogrel or heparin
* inability to obtain informed consent
* known existence of life threatening diseases with a life expectency less than 6 months
The Change of Tissue Oxygen Saturation Following Volatile Anesthesia

General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity. However, the differences in microcirculation caused by anesthetic methods have not been well studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy population.

This prospective, observational study will be performed on 60 healthy patients who had undergone elective surgery under volatile general anesthesia. The investigators measure StO2 and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The parameters were performed twice per patient, before and after the induction of anesthesia.

Occlusion slope and recovery slope during VOT will be compared before and after anesthesia. Moreover, the changes depend on the age will be analyzed.

This prospective observational study was performed on 60 patients without comorbidities who underwent elective surgery under general anesthesia. Before and after the induction of anesthesia, StO2 monitoring and VOT were performed to investigate the effect of anesthesia on microcirculation. To investigate the effect of age on microcirculation, the patients were divided into two different groups, young (\< 65 yrs) and old (\> 65 yrs) groups, and the VOT-derived parameters and hemodynamics between two groups were compared.

Eligibility Criteria:
Inclusion Criteria:

* Adult Over 18 years of age undergoing general surgery under general anesthesia.

Exclusion Criteria:

* ASA category III or IV, Diabetes, Chronic Kidney Disease, Vascular Disease
Healthy Term Infants Fed Milk-Based Formulas

This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.


Eligibility Criteria:
Inclusion Criteria:

* Infant is in good health
* Infant is a singleton from a full term birth with a gestational age of 37-42 weeks
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz)
* Infant is between 14 and 28 days of age
* Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
* Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
* Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance
A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

This is a Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation.

This is an open-label, multi-center, first-in-human, Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 an oral SMARCA degrader in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation. Approximately 104 participants will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures
* Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mutation of SMARCA4 by local testing that has either progressed on or is ineligible for standard of care therapy
* Must have measurable or non-measurable (but evaluable) disease per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Willing to provide either archival or fresh tumor tissue sample
* Adequate organ function (hematology, renal, and hepatic)

Exclusion Criteria:

* Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression
* Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
* History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study
* Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4).
Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients

Primary Purpose:

1. Evaluate the prevalence and incidence of HEV infection in MHD patients.
2. Compare differences of the prevalence and incidence between the MHD patients and the control. .

Secondary purpose:

Analyze risk factors of HEV infection.

This is an Epidemiological study manufactured by Xiamen University. The primary purpose of this study is to evaluate the prevalence and incidence of HEV infection in MHD patients and to compare differences between the MHD patients and the control. The secondary purpose of this study is to analyze risk factors of the infection of HEV. There are two phases in this study. The first phase is a cross-sectional study. Approximately 200 MHD patients will be enrolled in MHD patient group, followed by control group's enrollment according to the age and gender of the MHD patient group. Blood samples and questionnaire were got at this time. Secondly, 100 enrolled volunteers in each group who is negative for HEV-IgM、HEV-IgG、HEV RNA will be introduced into the cohort study. The MHD patient group will been taken blood samples at an interval of 3 month until the 12th month after the first phase, however, the control group only need one blood sample at 12th month.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis patients and healthy people as control
* Can understand the study progress, willing to sign the informed consent and participate the study

Exclusion Criteria:

* Has received HEV vaccines
Ulipristal Acetate in Symptomatic Uterine Fibroid

This study evaluates the effectiveness and safety of ulipristal acetae (UPA) in women with symptomatic uterine fibroids. Those who fulfilled inclusion/exclusion criteria will be treated UPA at daily dose of 5mg.

There is increasing evidence approving role of medical therapy in treatment of symptomatic uterine fibroid, in the context of women's desire to preserve fertility or not to undergo operation.

Among these hormonal therapies, ulipristal acetate (UPA) is an orally administered selective progesterone receptor modulator commonly prescribed for treatment of uterine fibroid. This agent acts on causing apoptosis of the muscle cells inside the tumor and reducing the tumor matrix in case of uterine fibroid.

UPA at daily dose of 5 mg has been shown to decrease menstrual blood loss and reduce tumor size after 13 consecutive weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-48
* Regular cycle of 22-35 days interval and FSH \<=20 mUI/mL.
* \>=1 uterine fibroid of 3\<= d \< 10cm (regardless of location), diagnosed by transvaginal ultrasound.
* Heavy menstrual bleeding (blood loss \>80ml/cycle).
* Uterine size \< 16 weeks of GA on clinical examination.
* Agree to participate in the study.

Exclusion Criteria:

* Previous or current treatment of uterus, cervix, ovarian or breast cancer.
* Previous endometrial ablation or uterine artery embolization.
* Abnormal PAP's smear result within 12 months prior to recruitment.
* Endometrial hyperplasia within 6 months prior to recruitment.
* Uterine polyp \>2cm.
* Ovarian cysts 4cm diagnosed by transvaginal ultrasound.
* Severe anemia (Hb 6 g/dl) or indication for blood transfusion.
* Coagulation disorder indicated for treatment.
* Increased liver enzyme level of twofold or more than normal upper limit.
* Previous use of SPRM.
* Treatment of systemic progestin or intrauterine device or hormonal contraception within 2 months, or use of GnRH analogue within 5 months prior to recruitment.
* Current use of acetylsalicylic acid, mefenamic acid, anticoagulation agents, antifibrinolysis agents, or systemic corticoid
Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle

The purpose of this study is to determine if short-term adoption of a Westernized lifestyle characterized by physical inactivity and increased consumption of fructose will result in metabolic and vascular dysfunction. Healthy individuals aged 18-45 years old will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption. Augmented fructose consumption will be achieved via commercially available soda beverages which are high in fructose. Vascular and metabolic function measures will be performed before and after the 10-day intervention.

Men and women who regularly engage in \>10,000 steps per day, age 18-45 years, body mass index \< 30 kg/m2, and with no history of chronic disease will be recruited. Subjects who are eligible will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption (6 cans/day). Physical activity levels will be assessed via a pedometer to quantify if individuals achieve \<5000 steps/day. Vascular and metabolic function measures will be performed before and after the 10-day intervention.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who regularly engage in \>10,000 steps per day
* Age 18-45 years
* Body mass index \< 30 kg/m2
* No history of chronic disease

Exclusion Criteria:

* Known cardiovascular disease including hypertension, heart failure, coronary artery disease, and stroke
* Renal or hepatic diseases
* Active cancer
* Autoimmune diseases
* Current use of immunosuppressant therapy
* Excessive alcohol consumption (\> 14 drinks/week for men and \>7 drinks/week for women)
* Current tobacco use
* Current pregnancy
* Diagnosis of type 2 diabetes
* Regular consumption of \>2 non-diet sodas/day
Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting

this work aims to evaluate xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting.

The alveolar cleft is a maxillary bone defect resulting from incomplete fusion of the medial nasal process (MNP) and maxillary process (MXP) during embryonic development. Alveoloplasty may be classified as primary, secondary, and tertiary depending on the age of the patient. Literature defines primary when the alveoloplasty is performed at the same time as soft tissue repair. If performed at the age of 8 to 9 years before the eruption of the permanent canine, it is classified as secondary; it is classified as late secondary or tertiary if performed in the elderly. For patients with cleft lip and palate, secondary alveolar bone grafting (SABG) of the cleft alveolar ridge is performed when the patient has mixed dentition; SABG is a procedure that aims to create a bony bridge that restores dental arch continuity, repair the oronasal fistula, provide support to the structure of the alar base, facilitate subsequent orthodontic treatment, and promote tooth eruption. Autologous bone grafting is the gold standard for treating alveolar clefts, with the iliac crest bone being the most widely accepted donor site. Other materials such as growth factors, combinations of improved scaffolds and cell treatment/growth factors, biocomposites, and hemostatic agents can be used to regenerate bone and have been the subjects of intensive research.

Eligibility Criteria:
Inclusion Criteria:

* Age (7 - 12 years).
* Non-syndromic CLA or CLP.
* More than 6 months of follow-up.

Exclusion Criteria:

* History of previous alveolar surgery.
* History of active infection or underlying diseases such as hematologic disorders, neoplasm, and immune deficiency
* Patients who had received primary or tertiary ABG.
Optimal Doses for Drug Provocation Tests to Beta-lactams

Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols.

investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).


Eligibility Criteria:
Inclusion Criteria:

* patients with positive Drug Provocation Test (DPT) to beta-lactams

Exclusion Criteria:

* contra-indications to DPT
* refusal of participation
* vulnerable patients according to French regulation
Collection and Storage of Human Biospecimens for Research Into Rare Diseases and Medical Conditions

The objective of this protocol is to enable collection of biospecimens to facilitate current and future multidisciplinary research in rare genetic disorders and medical conditions.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written, signed informed consent
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Use of any investigational product or investigational medical device within 30 days prior to screening, except as part of a BioMarin-sponsored study
* Concurrent disease or condition that would interfere with study participation or safety.
The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting

The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI).


Eligibility Criteria:
Inclusion Criteria:

* First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy;
* Right-handed and aged 18 to 75 years;
* Karnosky performance status (KPS) ≥ 70;
* Life expectancy ≥ 6 months.

Exclusion Criteria:

* Had brain metastases or other concurrent life-threatening diseases;
* Nausea and/or vomiting were present 24h before chemotherapy treatment;
* Suffered from or had a history of gastrointestinal diseases;
* Had a history of head trauma, serious neurological or psychiatric disorders;
* Participating in other clinical trials currently;
* Had any contraindication to exposure to a high magnetic field or receive acupuncture
A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients

This study looks at controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs).


Eligibility Criteria:
Inclusion Criteria:

* A medical diagnosis of a condition that requires daily Nonsteroidal Anti-Inflammatory Drugs (NSAID) treatment for at least 5 days per week for 1 month prior to entering the study and during the study.
* Some patients will need to undergo an upper endoscopy at screening.

Exclusion Criteria:

* Signs of clinically significant (GI) bleeding (e.g., melena, frank hematochezia) at the time of the baseline EGD or within 3 days prior to randomization.
* History of gastric or esophageal surgery (including but not limited to Nissen fundoplication, bariatric surgery (e.g. gastric stapling or Roux-En-Y gastric bypass), vagotomy, or Billroth operation).
* Many further exclusion criteria, please refer to the investigator site.