cyrilzakka/clinical-trials huggingface dataset:
Could Single-anastomosis Gastric Bypass Be a Curative Treatment for Type II Diabetes?

Single- Anastomosis gastric bypass (SAGB) is a potentially curative line of treatment for type II diabetes mellitus (T2DM) patients with BMI 25-30 kg/m2. Accordingly, SAGB could be integrated into T2DM treatment algorithm

Background: T2DM has been considered as a chronic progressive incurable metabolic disease. Single-anastomosis gastric bypass (SAGB) was shown to be effective in obese patients in terms of weight reduction and T2DM remission, yet its effect on non-obese diabetics is not extensively studied. In this study, we tried to determine the anthropometric and glycemic outcomes of SAGB as a proposed line of treatment for type II diabetes mellitus (T2DM) patients with body mass index (BMI) 25-30 kg/m2.

Methods: From November 2013 to March 2016, a prospective study has been conducted at Ain-Shams University hospitals on 17 consecutive patients undergone SAGB. The demographic and anthropometric data of the patients, as well as their relevant laboratory results, were reported, other data including anti-diabetic medications, co-morbid metabolic diseases were also assessed. All patients were scheduled for laparoscopic SAGB and were advised to come in regular follow up at 1, 3, 6, 12 and 18 months postoperatively. T2DM Remission is considered if glycosylated hemoglobin (HbA1c) \<6.5 % and fasting plasma glucose (FPG) \< 126 mg/dl for at least 1 year without medication.

Eligibility Criteria:
Inclusion Criteria:

.Type II diabetic patients.

* Age: 20-60 years.
* either gender.

Exclusion Criteria:

* Previous bariatric surgery.
* Controlled T2DM.
* Duration of T2DM \>10 years.
* Patients with endocrinal diseases,
* Pregnancy.
* Those unfit for general anesthesia.
Effects of Graft Vascular Dimensions on Surgical and Functional Outcomes of Living Donor Kidney Transplantation

1. Correlate the radiological and intraoperative measuring of the vascular dimensions,
2. Assess the effect of the vascular dimensions on the short-term surgical complications and
3. Assess the effect of the vascular dimensions on the primary graft function in pediatric and adults KTs.

Vascular complications after kidney transplantation (KT) are variably rare with an incidence of 3-15%. They are a significant and most serious part of surgical complications of KT. They may acutely result in graft loss during surgery or early in the perioperative period and may threaten patient's life. The most common forms of early vascular complications are haemorrhage, hematomas, arterial or venous thrombosis, arterial vasospasm, and arterial intimal dissection. In pediatric and adult KT, most studies addressing the vascular complications followed a common attitude of estimating the prevalence and management of these complications rather than studying the predisposing factors. Specifically, studying the normal and abnormal anatomy of the grafts has mainly been directed towards the number of graft vessels. However, there are many other vascular parameters that may potentially influence the outcome of vascular anastomosis and therefore the graft and patient outcomes. To the best of the investigators knowledge, the vascular dimensions of the renal and iliac vessels, such as the length, diameter and site of anastomosis to the iliac vessels have not been studied before so the investigators hypothesis that these dimensions can unequally affect the outcomes of surgery and early graft function in KTs. Hence, this study will be conducted to assess the effects of the vascular dimensions on the outcomes of surgery and primary graft function in pediatric versus adult living donor KT.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric and adult patients undergoing living donor kidney transplantation.

Exclusion Criteria:

* Patients with acute graft rejection occurring within the first week of transplantation.
* Patients refusing participation in the study.
Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia

In this study of neonatal male circumcision (NMC), the investigators will examine acceptability of among parents, feasibility of training providers and implementing services in various clinical settings, and the safety of service provision comparing three different surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is being conducted to inform the scale up of neonatal male circumcision in Zambia.

As male circumcision becomes one component of Zambia's plan to prevent the spread of HIV, it is important to understand the acceptability, feasibility, and safety of implementing NMC services in various clinical settings.

In this study, we will examine the acceptability of neonatal male circumcision among parents in several ways. First, we will administer a structured questionnaire on NMC to 1000 consenting parents of newborn boys at a tertiary care institution and 1-2 primary care clinics in Lusaka. All parents approached, regardless of whether or not they complete the survey, will also be offered an opportunity to have their sons circumcised. Uptake will be calculated as the percent of parents approached who consent for their sons to be circumcised. Finally, we will assess parental satisfaction with results of the procedure.

To examine the feasibility of training providers and implementing neonatal male circumcision services in various clinical settings, we will train a group of 15-20 health care providers in three different circumcision methods (Gomco clamp, Mogen clamp, and Plastibell) at 2-3 study sites. We will recruit 600 infants to be circumcised during the training. We will use structured questionnaires and skill assessments to evaluate provider competence after completing the training curriculum, provider preferences among the three circumcision methods, and opinion about how NMC should be scaled up within the existing health care system. We will also document logistical difficulties of scaling up NMC services at the study sites.

Finally, we will examine the safety of implementing NMC by collecting and analyzing data on complications resulting from the different circumcision methods.

Eligibility Criteria:
Inclusion Criteria:

* Male infants who are in the first day of life (including infants \< 24 hours old) and up to 4 weeks of age will be considered for circumcision
* Gestational age \>37 weeks at birth

Exclusion Criteria:

* Any current illness
* Bleeding diathesis or family history of bleeding disorder
* Abnormality of urethra or penile shaft such as hypospadias
* Local infection defined as redness, swelling, or a purulent discharge from the infant penis
* Greater than four weeks of age
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Must have recovered from all side effects of their most recent systemic or local treatment
* Adequate hematological, renal and liver function

For solid tumors only:

* Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist
* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)

For multiple myeloma only:

* Confirmed diagnosis of multiple myeloma with a BRAF V600 mutation
* Must have received at least one prior systemic therapy for the treatment of multiple myeloma
* Treated with local radiotherapy
* Must have relapsed and/or refractory multiple myeloma with measurable disease

Exclusion Criteria:

* Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma)
* Uncontrolled concurrent malignancy
* Multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
* Active or untreated central nervous system (CNS) metastases
* History of or known carcinomatous meningitis
* Concurrent administration of any anti-cancer therapies other than those administered in this study
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Switzerland, as Part of Local Clinical Practice (SURE SWITZERLAND)

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Participants will complete these questionnaires during their normally scheduled visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
* Available and documented haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of semaglutide treatment

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Treatment with any investigational drug within 90 days prior to enrolment into the study
* Hypersensitivity to semaglutide or to any of the excipients
A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors

A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of M1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of M1-c6v1, and preliminarily exploring the anti-tumor effects of M1-c6v1.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
2. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
3. Males and females at least 18 years of age, inclusive, at the Screening Visit.
4. Have at least one measurable lesion.
5. An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
6. An estimated survival time of ≥ 12 weeks.

Exclusion Criteria:

1. Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
2. Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
3. Subject has received systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP.
4. Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
Venetoclax and Decitabin Based Conditioning Regimen Followed With Post-HSCT Decitabin Maintenance Therapy in TP53 Mutant AML/MDS Patients

This study aims to evaluate the effectiveness and safety of Venetoclax and Decitabin based conditioning regimen followed with post-HSCT Decitabin maintenance therapy in TP53 mutant AML/MDS Patients.

In acute myeloid leukemia and myelodysplastic syndromes, TP53 gene mutation is a poor prognostic factor and a strong indication for hematopoietic stem cell transplantation. However, because of the high relapse rate of myeloid tumors with TP53 mutation, new comprehensive treatment is urgently needed to improve the efficacy of transplantation. Decitabin(DEC) has shown certain efficacy in primary patients with TP53 mutation, and Venetoclax (VEN) and DEC have synergistic effect. Based on this, we hypothesized that DEC and VEN should be added to the conditioning regimen in TP53 mutant AML/MDS patients in order to eliminate malignant clones with P53 mutation as much as possible, and intermittent DEC maintenance therapy should be used to prevent relapse after post-HSCT hematopoietic reconstruction. We intend to conduct a multicenter, single-arm clinical study to evaluate the efficacy and safety of this protocol.

Eligibility Criteria:
Inclusion Criteria:

1. AML or MDS diagnosed according to 2016 WHO criteria with TP53 mutation before enrollment;
2. Aged from 12 to 70 years;
3. The Eastern Cooperative Oncology Group (ECOG) performance score of 0-2;
4. Creatinine clearance rate ≥ 60 mL/min (according to Cockcroft-Gault formula);
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 3× upper limit of normal range (ULN), total bilirubin ≤ 2×ULN;
6. Left ventricular ejection fraction (LVEF) assessed by echocardiography (ECHO) ≥ 45%;
7. Life expectancy \> 8 weeks;
8. Sign the informed consent voluntarily, understand and comply with all trial requirements.

Exclusion Criteria:

1. Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc.
2. Current active cardiovascular disease with clinically significance, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease determined by the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within the 6 months prior to screening;
3. Other serious medical conditions (e.g., advanced infection) that may limit the patient's participation in the trial;
4. Known human immunodeficiency virus (HIV) infection, or drug-uncontrolled chronic infection of hepatitis B virus (HBV-DNA \> 1000IU/ml) or hepatitis C virus (anti-HCV positive);
5. Pregnant or lactating women;
6. Fail to understand, comply with the study protocol or sign the informed consent form.
Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer

This study will test a decision support intervention that consists of a web-based 'decision aid and planning tool' for family building after cancer in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Assigned female at birth
* Aged 18 to 45 years old
* Understands verbal and written English
* History of a cancer diagnosis.
* Completed cancer treatment(s) with known or uncertain gonadotoxic effects (e.g., systemic chemotherapy, surgery or radiation affecting reproductive organs or hormone regulation, stem cell or bone marrow transplant, and/or immunotherapy)
* Interested in having a future child (or more children) or uncertain about family building plans
* Access to the Internet and use of a computer, tablet, or smartphone
* Ability to understand and the willingness to personally sign the written IRB-approved informed consent document

Exclusion Criteria:

* Currently undergoing cancer treatment excluding long term adjuvant or maintenance therapies, such as tamoxifen
* Significant physical or mental disability that prevents completion of study activities
R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL

This is an investigator-initiated Phase 2 study, which combines R-EDOCH with Ibrutinib to treat patients with Ritcher Transformation in consideration of DLBCL and CLL components both could being targeted at the same time. The investigator will observe the 2-year overall survival rate of this regimen for RT and explore the new regimen for RT in the novel drugs era, which aims to improve the efficacy and prolong survival.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years
2. ECOG 0-2
3. Confirmed Richter transformation, whether or not previously treated
4. Unexposed to BTKi, or discontinue BTKi more than 1 year (due not to toxicity or ineffectiveness)
5. No serious liver, kidney, heart and other complications; including: a. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); b. total bilirubin (TBIL) ≤ 1.5 times the ULN; c. serum creatinine (Cr) ≤ 2 times the ULN, or glomerular filtration rate ≥ 40ml/min; d. LVEF \> 50% determined by echocardiography; e. no arrhythmia and active heart disease, such as coronary heart disease, myocardial infarction, etc
6. The patient agreed to participate and signed the informed consent form

Exclusion Criteria:

1. Major surgery within 4 weeks prior to first dose of ibrutinib
2. Require receiving anticoagulation with warfarin or equivalent Vitamin K antagonists; Requires treatment with a strong CYP3A4/5 inhibitor
3. Require corticosteroid , anti-cancer drugs, immunomodulatory or Chinese medicine for other medical conditions
4. Pregnant or lactating women
5. History of prior malignancy
6. Currently active clinically significant cardiovascular disease
7. Uncontrolled active systemic fungal, bacterial, viral, or other infection
8. Known history of human immunodeficiency virus (HIV) or active infection with Hepatitis B or Hepatitis C
9. History of stroke or intracranial hemorrhage prior to randomization
10. Other conditions that is unfit for the clinical trial in the investigator' opinion
Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block and External Oblique Intercostal Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: a Two-Center Randomized Controlled Trial

The primary aim of this study was to compare the postoperative analgesic efficacy of the Anterior Quadratus Lumborum Plane Block and the External Oblique Intercostal Plane Blocks used in laparoscopic cholecystectomy surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo laparoscopic cholecystectomy and who meet the ASA I-II risk classification between the ages of 18-65 will be included.

Exclusion Criteria:

Patients who do not agree to participate in the study, who have an infection in the application area, who are allergic to local anesthesia, who have coagulopathy, who are morbidly obese (Body mass index (BMI)\>35), who have a history of drug allergy, chronic pain, long-term opioid use and psychiatric illness, and who require emergency surgery are excluded from the study. will be left

-
Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination

The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.

Infectious diseases such as trachoma and lymphatic filariasis are public health problems in regions of Africa and Asia. Elimination programs exist for the two diseases, and their treatment by different groups of health workers is both costly and inefficient.

Thus, a study evaluating the safety and feasibility of an integrated mass treatment of trachoma and lymphatic filariasis with azithromycin associated with albendazole and ivermectin was instituted in 4 villages of the region of Sikasso in Mali (West Africa) co endemic for lymphatic filariasis and trachoma.

It was an open label randomized clusters type on the assessment of the safety of the triple co administration of azithromycin, ivermectin and albendazole (experimental regimen) as compared to the administration of the co administration of albendazole plus ivermectin followed by the that of azithromycin a week later (current standard recommended regimen) within subjects of 5 to 65 years old, willing and able to swallow the study drugs.

Clinical evaluation of adverse events in all study participants was done on day 0, day 8, and day 15 after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Must have been residing in the village for at least three months;
* Must be 90 cm tall or more;
* Must be between 5 years and 65 years of age;
* Must not be pregnant;
* Must not be lactating.

Exclusion Criteria:

* Subjects under 5 years of age or less than 90 cm in height;
* Subjects over 65 years of age;
* Subjects who cannot swallow tablets;
* Subjects who are sick and bedridden;
* Pregnant women (clinical appreciation in the study);
* Lactating women;
* History of allergies to the drugs being studied (azithromycin, ivermectin, albendazole).
Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial

This is a clinical trial of a cash transfer on symptoms consistent with COVID-19 and adherence to physical distancing guidance.


Eligibility Criteria:
Inclusion Criteria:

* trouble "making ends meet at the end of the month" due to COVID-19 related disruptions

Exclusion Criteria:

* confirmed positive for COVID-19 based on laboratory testing
* current symptoms consistent with COVID-19
A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
* BMI between 18.5 to 32 kg/m2.
* Total body weight ≥40 kg and ≤120 kg.

Exclusion Criteria:

* Previous treatment with an antibody within 6 months prior to Day 1.
* Pregnant or nursing females; females of childbearing potential.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.