cyrilzakka/clinical-trials huggingface dataset:
Maximizing Native Arteriovenous Fistulae Rates.

The purpose of our study is to compare physical examination alone to color Doppler ultrasonography (CDUS) vascular mapping and physical examination in terms of outcomes of vascular access and long-term patency.

Fistula maturation is a complex vascular remodelling process that requires vessel dilation, increases in volume flow rates in the feeding artery and afferent vein and structural alterations of the vascular wall. The understanding of these procedures and the factors involved in promoting maturation is limited. In this context, one of the major areas requiring investigation is the identification of clinically useful pre-operative predictors of access outcome.

Traditionally, the selection of vascular access and the eligibility for native arteriovenous fistula construction was mainly determined by findings of clinical examination. However, in addition to a complete history and physical examination, National Kidney Foundation/Dialysis Outcome Quality Initiative (NFK/DOQI) recommended that routine pre-operative color Doppler ultrasonographic vascular mapping should be performed in all hemodialysis patients who are candidates for access formation. This concerns the routine implementation of a non-invasive, safe and cost-effective method that permits the identification of vessels that are suitable for arteriovenous fistula (AVF) construction, acknowledging that supporting Level I evidence is still lacking. Indeed, available data supporting the significance of mapping on access maturation and patency rates are limited and conflicting.

The aim of the present study is to compare the type of preoperative assessment, physical examination alone to combined CDUS vascular mapping and physical examination, to outcomes of performed vascular access procedures with respect to type selection and long-term patency at 12 months in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease

Exclusion Criteria:

* poor life expectancy
* congestive heart failure New York Heart Association stage 3 and over
* candidates for tunneled catheters
Collagenase in the Treatment of Dupuytrens Disease

The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.

In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to disrupt the Dupuytren's cord.

Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were at least 18 years of age, of either sex or any race.
* Subjects had residual Dupuytren's disease with a fixed-flexion deformity of the finger(s) of at least 20 degrees or greater, caused by a palpable cord.
* Subjects had a positive "table-top test" defined as the inability to simultaneously place their affected finger(s) and palm flat against a table top.
* Subjects must have been willing to participate in and complete the study, and comply with its procedures by signing an IRB approved written consent form.
* Subjects must have been able to understand and adhere to the visit schedule. They must have been able to follow study procedures and instructions, and have agreed to report concomitant medications and adverse events accurately and consistently.
* Women of childbearing potential must have agreed to use an acceptable method of birth control or must have been surgically sterilized (hysterectomy or tubal ligation). Women of childbearing age had a urine pregnancy test on Day 0 (day of injection) prior to the injection.

Exclusion Criteria

* Women who were nursing or who were pregnant (as evidenced by a positive urine pregnancy test at the time of enrollment).
* Subjects who had participated in an investigational drug trial within 30 days of enrollment in this study.
* Subjects who had received surgery for Dupuytren's disease within 30 days of enrollment in this study.
* Subjects who had a known allergy to AA4500 or any of the inactive ingredients in the AA4500 injection.
* Subjects who had a known allergy to doxycycline.
* Subjects who had a medical condition that would have made them unsuitable for enrollment.
Topical Anesthetic Use In Pessary Management

The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.

Lidocaine-prilocaine (EMLA 5%) cream has been shown to be effective in reducing pain during minor gynecologic procedures. The primary objective of this trial is to determine if the use of 5% EMLA cream at the time of pessary removal and insertion reduces pain when compared to the use of placebo cream.

Participants will be randomized to receive either 10 grams of 5% EMLA cream (4 mL) or 4 mL of placebo cream (aqueous cream BP). Cream will be applied in office at the time of pessary removal and insertion.

Eligibility Criteria:
Inclusion Criteria:

* Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI)
* Read and speak the English language

Exclusion Criteria:

* Non-English speaking
* Allergy or contraindication to topical anesthetic
* Participation/randomization in the study at a previous visit
* Currently pregnant or lactating or planning a pregnancy within the next 6 months
Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study

This clinical study is designed to evaluate the providing of a computational prediction engine for optimization of personalized nutrition

Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month.

Pre-diabetic and pre-metabolic syndrome patients will be recruited to the study for a period of one year.

After measurement of individual's parameters changes as blood tests, gut microbiome, urine tests, blood pressure, heart performance, body circumferences, mood and mental status as well as monitoring each individual's food intake - a model to predict individual's body reaction according to lifestyle, eating and activity habits will be built.

Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18-65
2. HBA1C between 5.5 and 7%.
3. Altered lipid metabolism
4. BMI \> 25
5. Signed Informed Consent

Exclusion Criteria:

1. Pregnancy
2. Usage of antibiotics within three months prior to participation
3. Chronically active inflammatory or neoplastic disease in the three years prior to enrollment
4. Chronic gastrointestinal disorder, including Inflammatory Bowel Disease and Celiac Disease
5. Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor
6. Active psychiatric disorder
7. Myocardial infarction or cerebrovascular accident in the 6 months prior to participation
8. Chronic immunosuppressive medication usage
9. Clinical depression
Impact of Home-Based Rehabilitation on Motor Function and Mood in Individuals With Disabilities

This study aims to evaluate the impact of a multidisciplinary home-based rehabilitation program on motor function and mood in individuals with moderate neuromusculoskeletal disabilities. Participants will receive personalized treatment plans over four months, including sessions in physical therapy, occupational therapy, nutrition, psychology, nursing, and podiatry. The study will measure motor function using the Berg Balance Scale and mood using the Beck Depression Inventory. This program will be conducted in the Magallanes region of Chile, involving participants recruited from the National Disability Registry.

This study is designed to assess the effectiveness of a comprehensive home-based rehabilitation program for individuals with moderate neuromusculoskeletal disabilities. The intervention will include a multidisciplinary approach, involving a team of healthcare professionals who will provide a range of services tailored to each participant's needs. The services will include 32 sessions of physical therapy, 8 sessions of occupational therapy, 4 sessions of nutrition counseling, 8 sessions of psychological support, and 4 sessions of nursing and podiatry care. The intervention will span four months, with a total of 82 hours of therapy per participant.

Participants will be evaluated at the beginning and end of the program using the Berg Balance Scale to measure motor function and the Beck Depression Inventory to assess mood. The study aims to demonstrat improvements in motor function and balance, with a reduction in fall risk, and to explore changes in depression levels among the participants.

Quality assurance procedures will include standardized training for all healthcare professionals involved, regular monitoring of therapy sessions, and adherence to established protocols for data collection and analysis. This study highlights the potential benefits of home-based rehabilitation programs and underscores the need for further research to explore long-term outcomes and additional measures to enhance patient well-being.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with moderate neuromusculoskeletal disabilities.
* Participants referred by recognized medical institutions.
* Able to provide informed consent.

Exclusion Criteria:

* Individuals with severe cognitive impairments that hinder their ability to follow the rehabilitation program.
* Participants with acute medical conditions that require immediate hospitalization.
* Pregnant women.
Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers

The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when administered to individuals suffering from venous leg ulcers.


Eligibility Criteria:
Inclusion criteria (Run-in period):

1. Caucasian male or clinically sterile female subjects
2. 40 years or older.
3. Ankle brachial index of at least 0.6.
4. Written informed consent obtained.
5. Subject legally competent and able to communicate effectively.
6. Subject likely to co-operate.
7. Uncomplicated venous ulcer as by clinical diagnosis.
8. Full skin ulcer.
9. Localisation above the foot and below the knee (wrist and malleoli included)
10. Duration of at least 3 months.
11. Area 3-20 cm2.

Exclusion criteria (Run-in period)

1. Visible signs of infection, black necrosis or discharge in the target ulcer.
2. More than \~20% slough after debridement.
3. Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol.
4. Other known etiology of the target ulcer.
5. Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs.
6. Concomitant systemic or topical treatment within 14 days prior to start of study medication with antibiotics or antiseptics for treatment of ulcer infection in target ulcer.
7. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives
8. Concomitant topical treatment within 14 days prior to start of study medication with any of the following:

   * NSAIDs, aspirin
   * Growth factors, or other biologically active agents
   * Products containing chlorhexidine, potassium permanganate, iodine or silver
9. Diabetes Mellitus requiring pharmaceutical treatment.
10. Co-morbidity with a life expectancy less than 6 months.
11. Co-morbidity expected to lower compliance.
12. Diagnosed kidney disease
13. Individuals sensitive to any of the study medication components.
14. Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study medication.
15. Known abuse of alcohol, drugs or pharmaceuticals.
16. Diagnosis of squamous epithelia carcinoma
17. Diagnoses of a serious psychiatric illness which may influence study participation.

Inclusion criteria (Randomization)

1. Subject likely to co-operate.
2. Ulcer area reduction less than 50% during run-in period.
3. Ulcer area 3-20 cm2.

Exclusion criteria (Randomization)

1.\& 2. = Run-in period criteria 1. \& 2.

3. Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values.

4.-10. = Run-in period criteria 6., 7., 8., 11., 12., 13., \& 14
Immune Modulation Therapy for Pompe Disease

The purpose of this study is to assess anti-recombinant human acid α-glucosidase (anti-rhGAA) antibody titers after treatment with immune modulation therapy in patients of Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

* The patient (and/or patient's legal guardian if patient is \< 18years) must provide written informed consent prior to any study-related procedures that are performed;
* The patient must have a confirmed diagnosis of Pompe disease defined as a documented acid α-glucosidase (GAA) enzyme deficiency from blood samples or 2 GAA gene mutations;
* The patient (and/or legal guardian) must have ability to comply with clinical protocol;
* Regimen A only: The patient is receiving enzyme replacement therapy, exhibits clinical decline, and has persistent high anti-recombinant human acid α-glucosidase (anti-rhGAA) antibody titers and/or tested positive for antibodies that inhibit enzymatic activity and/or uptake of Myozyme;
* Regimen B only: The patient is cross-reactive immune material (CRIM) -negative AND have not received Myozyme infusion prior to enrollment

Exclusion Criteria:

* The patient is at risk of reactivation or is a carrier of Hepatitis B or Hepatitis C;
* The patient is at risk of reactivation of tuberculosis or has regular contact with individuals who are being actively treated for tuberculosis;
* The patient has used any investigational product (other than alglucosidase alfa) within 30 days prior to study enrollment;
* The patient is pregnant or lactating;
* The patient has had or is required to have any live vaccination within one month prior to enrollment.
Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.


Eligibility Criteria:
Inclusion Criteria:

* Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Exclusion Criteria:

* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
* Donation of blood at any point throughout the study and for 30 days after last dose of study medication
Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bioptically verified breast cancer
* Estrogen receptor-negative status
* Age: \< 70 years
* WHO Performance Status \< 2
* Laboratory parameters

  1. hematopoiesis: \> 3500/mm3 leukocytes, \> 100,000/mm3 thrombocytes
  2. renal function: creatinin \< 1.5mg%
  3. hepatic function: GOT max. 2.5 x UNL
  4. bilirubin: \< 2.0 mg %
  5. metabolic parameters: Na, Ca, K in normal range
* \</= 4 weeks interval since surgery
* Informed consent

Exclusion Criteria:

* Patients with locally inoperable cancer, M1
* Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment
* Pregnancy or lactation
* General contraindication against cytostatic treatment
* T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer
* Lacking compliance or understanding of disease
* Serious concomitant disease
* Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
EDOCH Alternating With DHAP for New Diagnosed Younger MCL

The purpose of this study is to:

1. determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years);
2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.

Enrolled patients will receive EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) ±R /DHAP(cisplatin, cytarabine and dexamethasone) ±R alternating chemotherapy. If a partial remission or better response achieves, patients will be recommended to receive autologous stem cell transplantation as consideration therapy or another two cycles EDOCH ±R /DHAP±R chemotherapy (based on patient's choice). Patients with less than partial remission (PR) response will quit this study. After treatments finished, maintenance therapy with rituximab or thalidomide plus prednisone will be given less than two years. The determination of maintenance regimens is dependent on patients choices.

Eligibility Criteria:
Inclusion Criteria:

* age≤65 years
* diagnosis with mantle cell lymphoma
* Ann Arbor stage II,III or IV
* ECOG≤1 or if ECOG≥2 but recover after pretreatment.

Exclusion Criteria:

* with centre neural system involvement
* serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
* HIV positive or active HBV infection or other uncontrolled systematic infection
* clinical central nervous dysfunction
* serious surgery within 30 days
* pregnancy or baby nursing period or un-contracepted child bearing period woman.
Study of Escitalopram in Adult Patients With Major Depressive Disorder

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the efficacy, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
* The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients who currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
* Patients who are considered a suicide risk.
* Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.
Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan

All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). frequently fast throughout Ramadan. However, many Muslim patients insist on fasting in spite of medical warning. So, the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting.

All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). frequently fast throughout Ramadan.

Although fasting during Ramadan is said to have positive effects on diabetes patients, such as a reduction in excess body weight and an improvement in lipid profile, it can be linked to a slight increased risk for metabolic complications that need immediate attention, such as hypoglycemia and hyperglycemia, dehydration, and diabetic ketoacidosis (DKA)

Similarly, an increase in hyperglycemic episodes was also noted in another study conducted by the Benghazi Diabetes and Endocrine Centre (BDEC) on 493 T2DM patients fasting during Ramadan where 10.7% experienced hyperglycemia. Therefore, appropriate treatment adjustments including insulin regimen are necessary to avoid both hypo and hyperglycemia during Ramadan fasting.

T2DM patients well-controlled on premixed insulin or multiple doses injections should not fast, and they have the legitimate exemption for this. However, many Muslim patients insist on fasting inspite of medical warning. So, the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian male and female Muslim patients,With T2DM, willing to fast Ramadan

  * . age ≥ 18 years old.
  * . type 2 diabetic patients treated with premixed insulin alone or combined with oral antidiabetic drugs (metformin, sulfonylurea: gliclazide, dipeptidyl peptidase 4 Inhibitor: sitagliptin or vildagliptin or thiazolidinediones/glitazones).

Exclusion Criteria:

* type 1 diabetic patients
* uncontrolled type 2 diabetics (HbA1c \> 9; but they were included if insisting on fasting despite the detailed medical advice very high-risk diabetics (according to IDF 2021 classification)9
* newly diagnosed as diabetics (\< 3 months)
* patients with previous ketoacidosis or hyperosmolar hyperglycemic states, recurrent or severe hypoglycemia within the past 2 months
* type 2 diabetic patients with hypoglycemic unawareness.
* Hospitalized patients, besides pregnant and lactating females