cyrilzakka/clinical-trials huggingface dataset:
A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants

The study tests if treatment with cagrilintide delays the transmission of electrical signals in the heart compared to treatment with placebo. To confirm the sensitivity of the methodology, the drug moxifloxacin is also compared to a placebo in 2 treatment arms. Cagrilintide is being developed for the treatment of obesity and weight management. Moxifloxacin is an approved antibiotic for the treatment of bacterial illnesses. The study lasts for up to 17 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 23.0 and 29.9 kilogram per meter\^2 (kg/m\^2) (both inclusive) at screening.

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products, or to electrocardiogram (ECG) electrodes.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* History of seizures, epilepsy, repeated syncopes, cardiac arrest, cardiac arrhythmia or Torsades de Pointes (TdP), 2nd or 3rd degree atrioventricular (A-V) block or structural heart disease.
* Family history of long QT syndrome (either objectively diagnosed or suggested by sudden death due to cardiac causes before the age of 50 of a 1st degree relative).
The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome

Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).

A total of 200 patients scheduled for lateral thoracotomy will be randomly assigned to receive either placebo or 150 mg pregabalin (Lyrica)1 hour prior to surgery, 12 hr after surgery and then every 12 hr for an additional 10 days. While in the hospital, patients will be assessed for pain intensity, satisfaction and side effects. Patients will be re-assessed at 2, 4 and 6 months following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, ASA class I II or III

Exclusion Criteria:

* Inability ot adhere to study protocol:

  * intolerance or hypersensitivity to any agents to be used in the study, contraindication to thoracic epidural placement
  * inability to respond to the study questionnaire
  * renal insufficiency(serum creatinine \> 1.5 upper limit of normal)
  * Body Mass index \> 40
  * planned post-operative ventilation.
* Confounding procedural factors which might affect validity of data:

  * previous ipsilateral thoracotomy
  * surgery for tumor extending into the chest wall
  * rest pain in proposed surgical area pre-operatively
  * chest tube in situ at time of surgery
  * requirement for second thoracotomy or re-occurrence of disease after surgery \*isolated pleuroscopy or pleurodesis procedures.
* Potential interaction with study medications and patient's current medications:

  * current alcohol or other substance abuse
  * chronic steroid use
  * pre-existing chronic pain requiring chronic analgesic use
  * history of seizure disorder requiring treatment with an anticonvulsant
  * current therapy with thiazolidinedione class oral hypoglycemic agents (eg, Actos, Avandia or Avandamet)
  * history of congestive heart failure
  * major psychiatric disorder
  * any contraindication to use of NSAIDs.
* Insufficient safety data in the patient population:

  * patients requiring preoperative assistance or assistive device for ambulation, pregnant or breastfeeding
  * weight \<50 Kg
  * dizziness while inpatient.
Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study

• The aim of this study is to compare between laparoscopic combined trans-vesical and extravesical versus laparoscopic extravesical fistula excision in uterovesical fistula repair.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with uterovesical fistula with history of uterine cesarean section or any urogenital surgery complaining of amenorrhea, cyclic hematuria, with or without urinary incontinence.

Exclusion Criteria:

* • Pregnant females.

  * Patients who refuse to participate in the study.
  * Patients with concomitant pathology that could affect symptoms e.g., polycystic ovary disease, stress incontinence, bladder cancer or overactive bladder.
  * Patients with malignant fistula.
Evaluation of Safety and Efficacy of Keratin Hair Therapy

Hair appearance is an important issue for females. Treatment of hair with keratin has been popular among females nowadays. Although chemical hair straightening application has a beneficial effect on hair shafts with the repair of the broken cuticle, some side effects may occur. Therefore, this study aims to study the efficacy and safety of such new non-formaldehyde widely used keratin treatments on hair by assessment of changes of the scalp, hair density, and the morphology, color, and ultrastructure of hair shaft after application.

Hair is an important feature for most women that contribute to one's individual identity. The appearance and morphology of the hair is one of the divergent traits in humans. Keratin in hair care products has two effects; it can penetrate the cortex of the hair fiber improving the mechanical properties of damaged fibers and promotes a surface coating that prevents or decreases water diffusion through the hair fibers.These properties have beneficial effects on the hair structure replacing lost keratin.However, the side effects and safety of this treatment have not yet been completely evaluated.There are many different brands of the keratin hair treatment, all with nearly the same basic chemical composition. Non-formaldehyde containing keratin straightening products, also known as safe keratin treatments (SKT) have recently been introduced to the market.Therefore, this study aims to study the efficacy and safety of such new non formaldehyde widely used keratin treatments on hair.

Eligibility Criteria:
Inclusion Criteria:

* The study will include female patients aged between 18 and 55 years, with hair curl types from III to V according to L'Oréal Curl Classification. The Patients will be randomized by simple randomization into 3 groups, 10 patients for each.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients having hair loss or under treatment of hair loss in last 3 months.
* Patients with previous history of keratin treatment.
* Patients with scalp affection including infection, injury or surgery
* Patients with chronic medical diseases.
* Patients with anemia (hemoglobin level \<10mg/dl) or under its treatment.
Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects.

The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Infection with Chronic hepatitis C genotype 1confirmed at screening;
* Anti-HCV positive；
* HCV RNA ≥1 × 10000IU / mL;
* Not treated with interferon and / or any other direct-acting antiviral (DAA) drug;
* Non-cirrhotic;
* Voluntarily sign informed consent.

Exclusion Criteria:

* HCV genotypes 2 to 7 or undetectable HCV genotype or mixed HCV genotype;
* Fibroscan detection result \> 12.9kPa or Histopathological examination result of patients is with cirrhosis;
* Past or existing evidence of the presence of non-HCV-induced chronic liver disease;
* Previous history of hepatocellular carcinoma, or suspected hepatocellular carcinoma found prior to screening, or suspected abdominal hepatoblastoma at screening or AFP\>100ng/mL;
* Anti-HAV (IgM) 、HBsAg 、anti-HEV (IgM) or anti-HIV is positive;
* BMI\<18 or≥30 kg/m2;
* ANC\<1.5×109/L、PLT\<100×109/L、HB\<110g/L（female）or\<120g/L（male）；INR\>1.5；ALT or AST≥5\*ULN；TBIL≥2\*ULN（DBIL≥ 35%TBIL）；Cr≥1.5\*ULN;
* Others as specified in detailed protocol.
Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics

This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.

We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.

Eligibility Criteria:
Inclusion Criteria:

* pathologically proved rectal cancer
* locally advanced rectal cancer (≥T3 or N+)
* a distance less than 12cm between the lower edge of tumor and the anal margin
* no evidence of distant metastases
* no prior anti-cancer therapy before treatment
* scheduled to receive preoperative CRT

Exclusion Criteria:

* history or concurrent of other malignancy
* incomplete preoperative CRT
* failed to receive surgery or unavailable pCR assessment
* poor quality of MR images for measurement
* patient quit
Spy II Clinical Registry

A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \>= 18 years of age
* Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry
* Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)

Exclusion Criteria:

* Subjects for whom endoscopic procedure are medically contraindicated
* Subjects for whom ERCP are medically contraindicated
* Subjects for whom medical condition warrants use of device outside of indication for use
The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

The main purpose of the protocol is to collect and evaluate performance data after patients undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive Digestive Disease Center (CDDC).

In general, the outcome data includes clinical management, hospitalization, and complications; to determine costs associated with endoscopy procedures; to determine performance data including technical success, procedure time, rate of repeat interventions; to compare endoscopy performance and outcome data collected at University of California, Irvine (UCI) and results from other institutions previously published in the literature. Additional parameters might be collected for specific interventional endoscopy procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 18 years of age or older
* Subjects who are scheduled for a procedure at the H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Exclusion Criteria:

* Subjects who are not 18 years of age or older
* Subjects who are scheduled for a procedure at the H. H. Chao Comprehensive Digestive Disease Center (CDDC).
Virtual Reality With Mirror Therapy on Upper Limb Function

The goal of this clinical trial is to address the effect of (Virtual Reality) and (Mirror Therapy) together on upper limb function in hemiplegic Cerebral Palsy children , male or female ranged between 3 to 10 years of age

. The main question of the study is Are there any significant differences between the effects of virtual reality , mirror therapy and the combined effect of both techniques and on upper limb function in hemiplegic CP children?

Participants will be subdevided into three groups A , B ,C Group (A): will receive VR in addition to designed physical therapy program Group (B): will receive MT in addition to designed physical therapy program Group (C): will receive the compound effect of both techniques in addition to designed physical therapy program

The goal of this clinical trial is to address the effect of (Virtual Reality) and (Mirror Therapy) together on upper limb function in hemiplegic Cerebral Palsy children , male or female ranged between 3 to 10 years of age

. The main question of the study is Are there any significant differences between the effects of virtual reality (VR), mirror therapy (MR) and the combined effect of both techniques (VR) and (MR) on upper limb function in hemiplegic CP children?

Participants will be subdevided into three groups A , B ,C Group (A): will receive VR in addition to designed physical therapy program Group (B): will receive MT in addition to designed physical therapy program Group (C): will receive the compound effect of both techniques in addition to designed physical therapy program

Eligibility Criteria:
Inclusion Criteria:

* Children will be included in the study if they fulfil the following criteria:

  1. A medical diagnosis of spastic hemiplegic CP made by pediatric neurologists.
  2. Children with spasticity grades ranged from 1 to 1+ according to MAS.
  3. Their age range from 4 to 10 years.
  4. Children level 1 and level 2 in gross motor functional classification (GMFC 1\&2)

Exclusion Criteria:

* Children will be excluded from the study if:

  1. They had a permanent deformity (bony or soft tissue contractures).
  2. Children having visual or auditory defects.
  3. Children who can not understand verbal commands
  4. Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand.
Online Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients

this study aimed to compare the removal of indoxyl sulphate between hemodiafiltration, high flux hemodialysis and low flux hemodialysis


Eligibility Criteria:
Inclusion Criteria:

* maintenance hemodialysis patients aged more than 18 years

Exclusion Criteria:

* active illnesses, hospitalization, malignancy
A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus

This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with basal insulin.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF)
2. Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)
3. Diagnosed with type 2 diabetes mellitus above or equal to 6 months
4. 7.5% ≤ HbA1c ≤ 10.0% at screening.

Exclusion Criteria:

1. Female who is pregnant, breast-feeding.
2. Presence or history of malignant neoplasm prior to screening.
3. Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening.
4. Known or suspected hypersensitivity to investigational medical product(s) or related products.
5. Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening
6. History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
7. Participation in a clinical study of another study drug within 3 month prior to randomization.
Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development

This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tolerance therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects diagnosed with haemophilia A (≤ 2% FVIII level in the absence of factor replacement, according to their medical history).
* Age 28 days to \<12 years.
* Subject is eligible for immune tolerance induction (ITI) therapy

Exclusion Criteria:

* The subject has received ITI previously.
* Subjects with a historical peak inhibitor titre of ≥ 200 BU/mL.
* Concomitant treatment with drugs with immunosuppressive side effects (eg, systemic corticosteroids), azathioprine, cyclophosphamide, high dose immunoglobulin or the use of a protein A column or plasmapheresis and interferons.
* High risk of cardiovascular, cerebrovascular, or other thromboembolic events (excluding catheter thrombosis) as judged by the investigator.
* Subjects who are human immunodeficiency virus (HIV)-1 or HIV-2 positive (as reported in the medical records or determined at screening).
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients

The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of any race between 18 to 70 years old (inclusive)
* Patients who gave written informed consent to participate in the study

Exclusion Criteria:

* Recipients of multi-organ transplantation
* Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.
* Graft cold ischemia time greater than 40 hours.

Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers

The purposes of this Phase 1 study of sevasemten are to:

1. Evaluate the effect of multiple-dose administration of verapamil on the single-dose of sevasemten in healthy adults
2. Evaluate the safety and tolerability of a single dose of sevasemten administered with and without verapamil in healthy adult subjects.
3. Evaluate the safety and tolerability of a single dose of sevasemten administered with and without food in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, adult, male or female (of non-childbearing potential)18-60 years of age, inclusive, at the screening visit.
2. Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
3. Body mass index (BMI) ≥ 18.0 and \< 30.0 kg/m2 at the screening visit.
4. Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or ECGs.
5. Willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
2. History or presence of alcohol or drug abuse (except for use of cannabis products) within the past 2 years prior to first dosing.
3. Female subjects of childbearing potential.
4. Alcohol consumption \> 14 drinks per week for males or ˃ 7 drinks for females within 45 days prior to the screening visit.
5. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
6. Any drugs known to be moderate or strong inducers of CYP3A4 enzymes/or P glycoprotein, including St. John's Wort, beginning 28 days prior to the first dosing.
7. Is lactose intolerant.
8. Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to first dosing, whichever is longer.
Management of Symptomatic Post-operative Lymphocele

Symptomatic lymphocele (LC) can be a complication after pelvic and para-aortic lymphadenectomy performed for treatment or staging purposes in the management of some cancers. Management procedures are: single or repeated puncture, prolonged drainage with drains or catheters, mostly followed by sclerotherapy, or surgery. A decision, which management option is most optimal, should be guided by two principles: first to control patient's symptoms, second to apply the least invasive but effective way to treat LC, taking into account that the patient has undergone major surgery recently, and often needs adjuvant treatment at the moment when symptomatic LC is diagnosed.

The aim of this study is to validate feasibility, safety and efficacy of a minimally invasive management of a symptomatic LC - drainage with the usage of vascular catheter followed by sclerotherapy, as well as to evaluate patient's experience on the treatment.

Patients with symptomatic LC are evaluated with ultrasound. Data about diameters, estimated volume of LC and other organs failure if appear is recorded. Management options are discussed with patient, and if the method with catheter insertion and drainage is chosen than the patient is eligible for the study. After vascular catheter insertion into LC and fluid evacuation, patient is followed with active drainage. Patients with drainage only are observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is considered. In case a patient does not agree to sclerotherapy, or there are contraindications, or it is doctor's decision that drainage alone is sufficient, than the prolonged drainage without sclerotherapy is the only procedure. The choice about the regimen used for sclerotherapy, it's volume, time intervals between repeated infusion depend on institution practice.

Data concerning feasibility, safety and efficacy are noted in designated templates. Patients' experience on the treatment is evaluated with formal questionnaire FACIT-TS-G.

The study is observational. Primary outcome measure is to establish efficacy of the method. Secondary outcome measures are safety and patient's experience on the treatment.

Investigators hope to establish step-by-step guidelines for optimal, minimally invasive management of symptomatic lymphocele.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic lymphocele after abdominal lymphadenectomy for cancer,
* age \> 18 years old,
* informed consent signed,

Exclusion Criteria:

* asymptomatic lymphocele,
* apparent infection of the skin or subcutaneus tissue over the lymphocele (in the place of potential catheter insertion),
* significant coagulopathy
Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension

The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Office Blood Pressure (BP): Sitting diastolic blood pressure (SDBP)100-109 mmHg (inclusive) and sitting systolic blood pressure (SSBP) \< 180 mmHg after a 2 week placebo run-in period
* Home Blood Pressure: diastolic blood pressure (DBP)at home ≥ 85 mmHg in the last week of the placebo run-in period
* Normal Electrocardiogram (ECG), first degree Atrioventricular block or other changes not considered clinically significant

Exclusion Criteria:

* Secondary or severe hypertension
* History of cerebro- or cardiovascular complications
* Type 1 or Type 2 diabetes on drug treatment
* Severe renal or hepatic insufficiency