cyrilzakka/clinical-trials huggingface dataset:
Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation

Background: Postpartum constipation is a common problem affecting postpartum mothers. Aim: To determine whether Whole Body Vibration is effective in treatment of postnatal women constipation. Design: The study was designed as a prospective, randomized, single-blind, pre-post-test, controlled trial.

HYPOTHESES:

It will be hypothesized that:

It was hypothesized that whole-body vibration has no or limited effect in treatment of postnatal constipation RESEARCH QUESTION: Does whole-body vibration has an effect in treatment of postnatal constipation?

Methods: Group A received whole-body vibration, pelvic floor exercise and static abdominal exercises interventions for six weeks and group B received pelvic floor exercises and static abdominal exercises in addition to diet instructions in both groups. Constipation symptom questionnaire and patient assessment of constipation quality of life questionnaire is applied before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* The participants age ranged from 22 to 35 years old
* with vaginal delivery
* complain from postnatal constipation from (2 - 6 weeks) post-delivery
* had body mass index (BMI) ranged from 30 to 32 kg/m2.

Exclusion Criteria:

Participants were excluded if they:

* had diabetes, hypertension, cardiac diseases.
* Women who had history of inflammatory bowel disease and abnormalities of anal region or anal fissure
* women who had history of bowel surgery (other than appendectomy),
* patients who had endocrine disease or digestive tract disease
* history of neurological or musculoskeletal disorder.
Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy

DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.

DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.

Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.

CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 to 70 years of age, inclusive
* Body mass index of 27 to 45 kg/m2
* Diagnosed with T2DM for at least 6 months before screening
* Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
* FPG ≤240 mg/dL at screening
* HbA1c ≥7.0% and ≤11% at screening
* A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

* Pregnant or breastfeeding women
* Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
* Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
* Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
* Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
* Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
Safety, Tolerability, and Pharmacokinetics of UX053 in Patients With Glycogen Storage Disease Type III (GSD III)

The primary objective of the study is to evaluate the safety of UX053 in adults with Glycogen Storage Disease Type III (GSD III).

This study is a phase 1/2 first-in-human (FIH), study to evaluate the safety, tolerability, and pharmacokinetic (PK) of a single ascending dose (SAD) and repeat doses (RD) of UX053 in patients with GSD III. The SAD cohorts will be open-label (OL). There will be two types of RD cohorts, an open-label (OL-RD) and a randomized, double-blind (DB), and placebo-controlled (DB-RD).

Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of GSD III by gene sequencing or enzymatic testing
* Alanine aminotransferase at or below 5 times normal during the three months prior to dosing
* Willing and able to comply with standard dietary management of GSD III

Inclusion Criteria for Participants Rescreening Into OL-RD Cohorts After Treatment with UX053 in SAD Cohort:

* If a significant rise in ALT occurs after the prior dose, ALT should show a decreasing trend toward the subject's baseline value
* Total bilirubin, platelets and international normalized ratio (INR) is within normal limits

Key Exclusion Criteria:

* History of liver transplant or currently awaiting liver transplant
* History of cirrhosis
* Active Hepatitis B or C
* Severe kidney impairment
* History of liver cancer or large liver tumors
* History of any cancer within the past 3 years
* Known history of HIV infection
* Known severe allergy to polyethylene glycol (PEG), polysorbate, or mRNA vaccine
* Heart failure that causes marked limitation in physical activity
* Poorly controlled diabetes
* Poorly controlled hypothyroidism
* Treatment with immunosuppressive medications such as those used to treat chronic autoimmune conditions and solid organ transplants
* Pregnant or nursing, or planning to become pregnant during the study

Exclusion Criteria for Participants Rescreening Into OL-RD Cohorts After Treatment with UX053 in SAD Cohort:

* New or worsening symptoms of liver disease (including new or worsening hepatomegaly) along with any increase in transaminase levels
* Receipt of any blood product administration (eg, packed red blood cells, platelet, FFP) for management of consumptive coagulopathy
* An ALT level that is ≥ 8x ULN and \> 2x the participants baseline value in the absence of an alternative explanation

Note: Additional inclusion/exclusion criteria may apply, per protocol
99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-HPArk2 in breast cancer patients. A single dose of 11.1Mega-Becquerel (MBq) per kilogram body weight 99mTc-HPArk2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

99mTc-HPArk2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-HPArk2 SPECT/CT in the detection of HER2-positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-HPArk2 SPECT/CT in stratifying breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with HER2 binding.
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose).

Eligibility Criteria:
Inclusion Criteria:

1. written informed consent;
2. ≥18 years of age;
3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;
4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
5. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

1. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
2. infected diabetic foot ulcers;
3. infected decubitus ulcers;
4. necrotizing fasciitis or gangrene;
5. uncomplicated skin or skin structure infection;
6. infections associated with a prosthetic device;
7. suspected or confirmed osteomyelitis;
8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
Probiotics and Allergic Diseases

Many studies had demonstrated that probiotics could be applied in the prevention and adjuvant treatment for allergic diseases. In this study, we investigate the effects of Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus paracasei GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used for adjuvant treatment of atopic dermatitis and asthma.

The main purpose: To investigate if Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090(LF), Lactobacillus paracasei GMNL-133 (LP) with Lactobacillus fermentum GM-090 (LF) combination products could be used for the adjuvant treatment of atopic dermatitis and asthma.

The Secondary Objective: To investigate whether probiotics consumption improve the quality of life and allergic symptoms to different people with Lactobacillus paracasei GMNL-133 (LP), Lactobacillus fermentum GM-090 (LF) and Lactobacillus paracasei GMNL-133(LP) and Lactobacillus fermentum GM-090 (LF) combination products.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 1 year old and 18 years old,
2. AD cases fulfill the diagnostic criteria by Hannifin and Rajka.
3. Atopy as shown by at least one positive skin test (weal size ≧ 3mm) or one positive MAST (RAST) (IgE ≧ 0.7 kU/L) test to any common food or environmental allergens.

Exclusion Criteria:

1. Systematic corticosteroid, immunosuppressive therapy, or antimycotics treatment during the 4 weeks, antihistamines, and singulair during the 7 days before enrollment
2. Probiotic preparations used within 2 weeks before entering the study
3. Use of antibiotics now or other oral medications that will interfere the results
4. If they had immune deficiency disease or other major medical problems
5. If they had participated in another clinical study during the past month.
6. Subjects are undergoing desensitization therapy within 3 months prior to the screening period.
7. Subjects have participated investigational drug trial within 4 weeks before entering this study.
8. Subjects are pregnant, lactating or planning to become pregnant.
9. Subjects with any other serious diseases considered by the investigator that could interfere with the performance of SCORAD score result.
10. Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers

The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

This pilot study will be the first time that nicotine will be applied directly onto the surface of chronic diabetic ulcer. The goals of the study are to evaluate safety and tolerability (particularly at the wound site) of a gel formulation containing low-dose nicotine, and to obtain preliminary information on its effects on accelerating wound closure. The study will be carried out on a background of conventional wound therapy in patients with Type II diabetes mellitus. Patients will be randomized to receive either study medication (ATG002), vehicle gel, or standard-of-care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus type II
* Single non-healing uninfected partial or full-thickness foot ulcer secondary to diabetic neuropathy, in the absence of significant peripheral arterial disease.

Exclusion Criteria:

* Patients who use tobacco in any form or who are on nicotine replacement therapy
The Evaluation for Fu's Subcutaneous Needling (FSN) in Carpal Tunnel Syndrome.

The goal of this clinical trial is to evaluate the efficacy of Fu's Subcutaneous Needling (FSN) in carpal tunnel syndrome (CTS). The main questions it aims to answer are:

* Dose FSN improve the symptoms of CTS?
* Dose FSN decrease cross section area of median nerve in CTS patients?
* Dose FSN have the effect of electrophysiology exam in CTS patients? Participants will receive wrist splinting and FSN treatment respectively. Researchers will compare wrist splinting group with FSN group to see if FSN being effective for CTS.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 20-85 years old.
2. Meet the diagnosis of mild to moderate carpal tunnel syndrome.
3. If the patient has carpal tunnel syndrome in both hands, choose the side with mild or moderate carpal tunnel syndrome.
4. After being explained, join the trial voluntarily and sign the subject's consent form.

Exclusion Criteria:

1. Caused by trauma or mass lesion.
2. Thenar muscle atrophy.
3. Electrophysiological examination revealed severe CTS.
4. Chronic kidney disease, rheumatoid arthritis, abnormal thyroid function, diabetes.
5. Psychiatric history or incapable of cooperating with the investigator.
6. Pregnancy.
7. History of substance abuse or long-term steroid use.
8. History of median nerve surgery.
9. Those who do not sign the consent form.
Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer

Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer

Chemotherapy induced peripheral neuropathy has a significant impact on the integrity of chemotherapy cycle and quality of life of breast cancer patients. The latest research reports indicate that electroacupuncture has a certain therapeutic effect on peripheral neuropathy. In addition, existing studies have confirmed that the peripheral neuropathy of breast cancer induced by taxane is related to genetic factors. This study is based on electroacupuncture treatment of peripheral neuropathy induced by paclitaxel drugs, while screening SNPs related to peripheral neuropathy induced by taxane drugs, and establishing a prognostic model. Eligible patients diagnosed as stage I, II or IIIA breast cancer with peripheral neuropathy for at least 2 weeks were assessed by functional cancer treatment assessment/gynecological oncology group neurotoxicity scale (FACT/GOG-NTX) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN Twenty Item Scale (EORTC QLQ-CIPN20). All items in the above two scales are scored using Likert's 5 and 4 levels. The researchers will temporarily divide the study into two groups, and if necessary, the researchers will add this group. Laboratory personnel are unaware of all clinical and outcome data.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients diagnosed by pathology;

  * EOOG score is 0 or 1;

    * The age range for enrollment is between 18 and 75 years old; ④ Accept chemotherapy regimens based on taxane drugs (alone or in combination);

      ⑤ Previously received taxane chemotherapy for more than 6 months;

      ⑥ According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0, reporting CIPN symptoms of grade 1 or higher for more than 2 weeks;

      ⑦ Voluntarily participate in this clinical trial and sign the informed consent form;
      * Accept regular follow-up visits; ⑨ There is complete pathological data available.

Exclusion Criteria:

* Non breast cancer patients;

  * Received electroacupuncture treatment within 6 months prior to the start of the study;

    * Patients who experience intolerable toxic side effects during standard dose chemotherapy and terminate the chemotherapy cycle;

      * Prior to enrollment, there was a history of peripheral neuropathy;

        * Unstable heart disease or myocardial infarction within the first 6 months of the study;

          ⑥ Active skin diseases or surface skin ulcers or infections that cannot tolerate electroacupuncture treatment;

          ⑦ Uncontrolled epilepsy patients with uncontrolled seizures;

          ⑧ Merge with other malignant tumor patients;

          ⑨ Pregnancy and lactation period;

          ⑩ Refusal to join clinical trial patients
Neonatal Outcomes in Twin Pregnancies

Multiple pregnancies are associated with increased maternal and fetal risks compared to singleton pregnancies. Additionally, the cesarean section rate is quite high in multiple pregnancies. This study aimed to evaluate maternal and fetal characteristics and factors affecting fetal outcomes in twin pregnancies delivered by cesarean section.

While the frequency of multiple pregnancies varies significantly among societies and individuals, especially in middle and high-income countries, the rate of multiple pregnancies has shown a significant rise worldwide in recent years, with the frequent use of assisted reproductive techniques, which has increased due to an increase in maternal age and a decrease in fertility. As a result, multiple pregnancies constitute approximately 2-4% of all births.

Multiple pregnancies are known to be associated with increased maternal and fetal risks compared to singleton pregnancies. While maternal mortality associated with a twin pregnancy is 2.5 times higher than in singleton pregnancy, adverse neonatal outcomes such as perinatal mortality, fetal growth restriction, and low birth weight are two to three times higher in twins than in singleton newborns. Moreover, neonatal near-miss, which refers to cases that almost resulted in death, is associated with multiple pregnancies.

For all these reasons, the planned cesarean section has been advocated over planned vaginal delivery to reduce the risk of adverse neonatal outcomes (especially for the second-born twin). However, cesarean delivery is known to be associated with a higher risk of maternal morbidity and poor neonatal outcomes. The vast majority of these risks are related to maternal hypotension, prolonged uterine-incision-to-delivery time, and general anesthesia. From this perspective, we aimed to evaluate maternal and fetal characteristics and factors affecting fetal outcomes in twin pregnancies delivered by cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Twin pregnancies
* Parturients delivered by cesarean section

Exclusion Criteria:

* The triplets or more multiple pregnancies
* Twins delivered through the vaginal route were excluded from the study.
ET190L1-ARTEMIS™ T Cells in Relapsed, Refractory B Cell Leukemia and Lymphoma

Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma

ARTEMIS™ is a novel chimeric T-cell therapy that in pre-clinical studies, functionally matches the efficacy of Chimeric Antigen Receptor (CAR) T cells, but dramatically reduces the release of cytokines upon killing of target positive tumors. The molecular target for ET190L1-ARTEMIS™ is Cluster of Differentiation 19 (CD19), which is expressed on B cell Lymphomas and B cell Leukemias. ET190L1-ARTEMIS™ is a second generation ARTEMIS™ receptor engineered with a human Fab antibody domain against CD19. This clinical study evaluates the safety and pharmacokinetics of ET190L1-ARTEMIS™ T-cells in patients with relapsed/refractory B-cell lymphoma and B-cell Leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed/refractory CD19+ B-cell lymphoma or Leukemia, with no effective therapy available per National Comprehensive Cancer Network (NCCN) guidelines
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2, expected survival time \> 3 months per PIs opinion
* Women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose.
* Peripheral venous access is available and no issues with apheresis for lymphocyte isolation
* serum alanine aminotransferase(ALT)\<200 Unit/L, ALT/Aspartate aminotransferase(AST)\<3 normal range; serum creatinine (Cr)\<2.5mg/dL
* Voluntarily signed informed consent form

Exclusion Criteria:

* Women in pregnancy and lactation
* Unable to perform leukapheresis and iv infusion
* With active infection
* Major organ failure
* Patients with dependence on corticosteroids
* Continuously used glucocorticoids or other immunosuppressive agents within 2 weeks
* T cell deficiency or T cells are difficult to be transduced
* Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
Relation of C-reactive Protein/ Albumin Ratio and Coagulation Profile in Acute Myeloid Leukemia Patients

The investigators will investigate the relation between CAR and coagulation profile in newly diagnosed AMl patients

Acute myeloid leukaemia (AML) is an aggressive haematological malignancy with a high degree of heterogeneity. It has long been recognized that systemic inflammation is associated with tumorigenesis it revealed that elevated C-reactive protein levels were associated with worse survival outcomes in patients with various types of cancer, including hematologic malignancies. Serum albumin is a measure of an individual's nutritional status. Systemic inflammation can reduce serum albumin concentrations by increasing capillary permeability . The ratio of CRP to albumin (CAR) is a useful score based on inflammation and nutrition, reflecting not only systemic inflammation status but also nutritional status. The Glasgow prognostic score (GPS) and modified GPS (mGPS), determined by the serum CRP and albumin levels, have been proposed as prognostic indicators for AML patients. However, the clinical correlations of CAR and its prognostic value in AML patients have not yet been clarified. Abnormalities of hemostasis can occur in leukemia in the form of disseminated intravascular coagulation(DIC), coagulation protein defect and primary fibrinolysis . Clinically, Types of acute myeloid leukemia like acute promyelocyticleukemia has a high frequency of haemorrhage due to disseminated intravascular coagulation (DIC), which contributes to the high mortality rate of this disease . Therefore, the investigators will investigate CAR its relation with inflammatory response and coagulation profile levels in newly diagnosed acute myeloid leukemia and after 3 month follow up to compare their level and the relation between .

Eligibility Criteria:
Inclusion Criteria:

- all cases newly diagnosed with acute myeloid leukemiain assuit university hospital

Exclusion Criteria:

1. cases with chronic myeloid leukemia
2. cases with acute lymphoblasticleukemia