cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview

The investigators aim to compare between laparoscopic clipping and extracorporeal ligation in complicated appendicitis regarding safety, efficacy, operative time, postoperative outcome, hospital stay and complications.

Appendectomy has become one of the most commonly performed emergency abdominal operations since it's description by McBurney in the 1890s. Since laparoscopic appendectomy was first described in 1983, there is an increase in the general trend towards performing this surgery using laparoscopy instead of open technique as this approach shows better pain score, lesser use of analgesics, less operative complications, better post operative recovery, less hospital stay and rapid return to normal work.

There are many methods for securing the base of the appendix, some of which are expensive others are not available or technically demanding. In this study the investigators aim to compare between extracorporeal ligation and clipping techniques regarding feasibility, safety, efficacy, operative time, postoperative outcome and complications especially in complicated appendicitis.

AS management of complicated appendicitis laparoscopically is possible, secure and can lead to a little occurrence of infectious complications, fewer post-operative pain, quick revival and improve cosmesis so the investigators will do a prospective clinical trial comparative study between two common techniques to determine the best one in management of complicated cases.

Eligibility Criteria:
Inclusion Criteria:

* Acute complicated appendicitis.
* Perforated appendicitis (diagnosed intraoperatively)
* Patients who will undergo laparoscopic appendectomy.

Exclusion Criteria:

* Patients with straight forward appendectomy.
* Patients who are not fit for laparoscopic appendectomy.
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm).

Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor.

Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration-resistant adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
* Participants must have ≥ 1 metastatic (measurable or non-measurable per PCWG3) lesion.
* Participant has prostate cancer progression at study entry based on PCWG3 criteria.
* Participant shows evidence of disease progression after receiving at least 1 prior androgen receptor axis-targeted therapy (ARAT) regimen (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide).
* Patients with known history of documented breast cancer gene (BRCA) mutation (germline or somatic) must have received an approved poly ADP ribose polymerase (PARP) inhibitor regimen.
* Participants must have adequate performance status, life expectancy and laboratory values.

Exclusion Criteria:

* Any condition preventing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
* Received prior chemotherapy for mCRPC or checkpoint inhibitors for prostate cancer.
* Current active or chronic infections.
* Any clinically significant heart, lung, or gastrointestinal disorders.
* Allergy to any of the study treatments or components of the study treatments.
Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise

The purpose of our study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the effect of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and aerobic exercise for improving PCOS disease features and risk factors for metabolic syndrome. We would like to determine the therapeutic effects of a lifestyle program that combines a pulse-based diet and exercise on the multiple disease measures of PCOS and metabolic syndrome.

To date, we have developed the pulse-based and meat-based healthy meals following Therapeutic Lifestyle Changes (TLC)guidelines recommended by NCEP for the intervention. We have been recruiting and enrolling participants into the study with our few set of participants having completed the 4 month intervention. Baseline data have been also collected on all participants assessed for PCOS. Preliminary measurements on POCS characteristics, baseline dietary and exercise habits of women with PCOS will be soon available.

This study involves an intervention comparing a diet containing pulses (i.e. beans, peas, chick peas, lentils) to a diet recommended by the National Cholesterol Education Program (NCEP) for improving markers of metabolic syndrome and fertility in women with poly cystic ovarian syndrome who are also enrolled in an aerobic exercise program. To date, seven women in the pulse-diet group have completed the intervention, nine women in the group receiving the NCEP diet have completed the intervention, four women are currently enrolled on the pulse diet and two women are currently enrolled on the NCEP diet.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosis of PCOS
* Aged 18-35 years

Exclusion Criteria:

* Taking birth control or fertility medications
* Medical conditions that limit exercise or which limit consumption of a pulse-based diet (allergies or intolerances)
Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543

This is an open-label, single-dose, sequentially designed, single-period study to determine the effect of moderate renal impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following administration of a single 12 mg oral dose of CTP-543.


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females aged 18-75
* Body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2 at the time of screening
* If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
* Capable of giving informed consent and complying with study procedures

Additional Inclusion Criteria for Subjects with Renal Impairment:

* eGFR of 30-59 mL/minute/1.73 m2 as calculated by the MDRD equation
* No clinically significant change in disease status within the last 30 days before screening
* The subject must have a condition consistent with renal impairment and associated symptoms, but otherwise be determined to be in good health in the opinion of the Investigator
* Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed with the exception of strong CYP3A4 inhibitors and inducers

Exclusion Criteria:

* History of any clinically significant medical condition, psychiatric disease, social condition, or illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
* Known history of any gastrointestinal surgery or any condition possibly affecting drug absorption
* History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) \> 470 msec for males or QTcF \> 480 msec for females at Screening visit
* Positive for human immunodeficiency virus, Hepatitis B virus, or Hepatitis C virus
* Females who are nursing or pregnant prior to drug administration
* Positive results for coronavirus infection (COVID-19) at screening or check-in
* Positive drugs of abuse or alcohol results at screening or check in (Day -1)

Additional Exclusion Criteria for Subjects with Renal Impairment:

* History of renal transplant
* Significant bleeding diathesis that could preclude multiple venipuncture or deep intramuscular injections
* Acute or exacerbating renal disease
* History of drugs of abuse or alcohol misuse within 6 months prior to screening
* Poorly controlled Type 1 or Type 2 diabetes
Pitavastatin on Carotid Intima-media Thickness

This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having hyperlipidemia
* LDL-C at the time of enrollment is no less than 100
* Common carotid IMT is 1.1 mm and over

Exclusion Criteria:

* Received or planned to receive intervention on carotid arteries during the study period
* Overt liver dysfunction (ALT; 100 IU/L and over)
* Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over)
* Receiving Cyclosporin
* Hyperreactive to Pitavastatin
* During pregnancy or lactation
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity

The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL (bupropion hydrochloride) on reward processing.

A cardinal feature of Major Depressive Disorder is anhedonia, which is a lack of pleasure in normally enjoyable activities. In order to understand reward processing in depressed individuals it is also necessary to study reward processing in people who are not depressed. Bupropion, the active drug in the anti-depressant Wellbutrin XL, has been shown to increase brain reward functioning in animals. The goal of the present study is to investigate the effects of Wellbutrin XL administered to psychiatrically healthy individuals as they perform a computer task known to assess reward processing.

Eligibility Criteria:
Inclusion Criteria:

* Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse)
* Non-Smoker
* Right-handed (Chapman and Chapman 1987)
* Ability to provide informed consent

Exclusion Criteria:

* Predisposition to seizure (e.g. family history of a seizure disorder, history of head trauma) or current use of medications that lower the seizure threshold
* History or current diagnosis of anorexia or bulimia
* Alcohol or substance abuse within the past year
* Current usage of Wellbutrin or Zyban or other drugs that contain bupropion
* Recent discontinuation of alcohol or sedatives (including benzodiazepines)
* Use of (in the last 2 weeks) medications that may have antidepressant properties (ex. some herbal supplements)
* Known allergies to bupropion
* Currently lactating, pregnant or believe you are likely to be pregnant (enrolled subjects who are not using reliable contraception and have engaged in sexual intercourse since their last menstrual period will be given a self-administered pregnancy test.)
* Left-handed/ambidextrous
* Evidence of neurological illness
* Serious suicide or homicide risk

Concomitant medications other than those listed in the exclusion criteria will be considered on an individual basis. Oral contraceptives will be allowed.
Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Soft Tissue Sarcoma

Ridaforolimus has been tested in almost 2 dozen studies; however, it has not previously been tested in combination with the standard of care chemotherapy for sarcoma as this study will. We will be looking to see if Ridaforolimus given with SOC chemo (AIM or TG) is well tolerated and to determine a Phase 2 dose.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic soft tissue sarcoma with histological or cytological proven disease. No more than 2 lines of chemotherapy in the metastatic setting in the dose escalation phase, and no more than one line of prior therapy in the expansion phase.
* ECOG performance status of ≤ 1
* A minimum life expectancy \> 3 months
* At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy or radiotherapy and the first dose of ridaforolimus
* Adequate hematological, hepatic and renal function (hemoglobin ≥ 9g/dl, absolute neutrophil count \[ANC\] ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; bilirubin ≤ ULN; alkaline phosphatase ≤ 2.5 x ULN; AST, ALT ≤ 2.5 x ULN; albumin ≥ 2.5mg/dL; creatinine ≤ 1.5 x ULN)
* Serum cholesterol ≤ 350 mg/dL and triglycerides ≤400 mg/dL
* Signed informed consent
* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of therapy and must use an approved contraceptive method as appropriate from the time of screening until 30 days after the last dose of study drug.

Exclusion Criteria:

* Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.
* Clinically significant unexplained bleeding within 28 days prior to entering the trial
* Uncontrolled systemic vascular hypertension
* Clinically significant cardiovascular disease
* Newly diagnosed (within 3 months of enrollment) or poorly controlled type 1 or 2 diabetes
* Have received \>350 mg/m2 total dose of Doxorubicin
* Active infection requiring prescribed intervention
* Other concurrent illness
* Major surgery within 28 days before trial entry, or incompletely healed surgical incision; minor surgery or procedures within 7 days
* Previous anthracycline lifetime exposure more than 350 mg/m2 would exclude patient form AIM Arm enrollment
* Pregnant or breastfeeding
* Known allergy to macrolide antibiotics
* Concurrent treatment with medications that induce or inhibit cytochrome P450 (CYP3A).
* Known history of HIV sero-positivity
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female aged 18 to 75 years, inclusive.
* Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points

Exclusion Criteria:

* Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
* Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.
Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook

The primary objective of this study is to obtain a greater understanding of the range in benefit from acoustic amplification combined with electric stimulation in cochlear implant recipients with low-frequency hearing who do not currently use the commercially approved Advanced Bionics Acoustic Earhook. The aims of this study are to 1) obtain subjective sound quality judgements of recorded speech and music samples, 2) assess vocal emotion perception, and 3) evaluate post-operative speech perception and sound field detection thresholds in CI recipients both with and without use of the acoustic ear hook.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Implanted with an Advanced Bionics Advanced Bionics HiRes Ultra, 90K, or CII implant, and using a Naída Q90 sound processor
* 18 years of age or older with post-lingual hearing loss
* Aided open-set speech recognition scores greater than 30% correct in quiet in the ear to be tested
* Unaided low frequency audiometric hearing thresholds of 90 dB HL or better at .125, .25, and .5 kHz
* Participants must have a working understanding of and ability to verbalize in English as the evaluation measures are available exclusively in English
* Willingness to use an acoustic component with their ear-level sound processor postoperatively for the duration of the study
* Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

* Exclusive use of a body worn external sound processor
* Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear
* Postoperative unaided low frequency audiometric hearing thresholds in the implanted ear exceeding 90 dB HL at any frequency from 125 - 500 Hz.
* Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation or outcomes measures.
Interaction Between Rimonabant and Cyclosporine and Tacrolimus

The major cause of premature death in renal transplant recipients is cardio-vascular disease. In addition, obesity is becoming a major problem in this patient population. Rimonabant does not only seem to have weight reducing properties but also weight reduction independent effects on insulin sensitivity and endothelial function, two important cardio-vascular risk factors. Rimonabant therefore is an interesting drug for the treatment of transplanted patients. Present data also indicate that rimonabant does not interact with essential immunosuppressive drugs (CsA and Tac) indicating that it most probably is safe to administer to this patient population. However this needs to be investigated in a proper manner.

Renal transplant recipients are treated with life-long immunosuppressive therapy in order to prevent acute rejection episodes. The calcineurin inhibitors (CsA and Tac) are the back-bones in the immunosuppressive treatment and they have a very narrow therapeutic index. It is therefore essential to assure that new drug to be used in transplanted patients do not interact with CsA and Tac. Even though rimonabant is metabolized via the same enzyme as CsA and Tac (CYP3A4) previous in vitro and in vivo studies with relevant probe drugs in healthy volunteers do not indicate the presence of any relevant pharmacokinetic interaction. However, to be absolutely sure that it is safe to administer rimonabant in transplanted patients a 12-hour pharmacokinetic interaction investigation is included for 16 patients in the present pilot study (8 patients on CsA and 8 patients on Tac).

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipient with stable renal function (less than 20% deviation in serum creatinine the last 2 months).
* Renal transplant recipient currently on CsA or Tac and prednisolone based immunosuppression.
* BMI \> 30 kg/m2 or \>27 kg/m2 in combination with one or more cardio-vascular risk factors.
* \> 18 years of age.
* Male patient, or female patient without childbearing potential (surgically sterilized or postmenopausal) or, if female of childbearing potential, is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 Days following discontinuation of the Study Drugs.
* Signed informed consent.

Exclusion Criteria:

* Diabetes mellitus
* Severe liver disease.
* Depressive-, anxiety- or sleeping disorders.
* Estimated GFR \< 25 ml/min.
* Epilepsy.
* Skin disorders that may influence laser Doppler flowmetry investigations.
* Pregnant or nursing mothers.
* Concomitant treatment with CYP3A4 inhibitors (www.cyp450.no) with interaction potential according to the investigator.
A Study of LY3857210 in Healthy Participants

The main purpose of this study is to evaluate the presence of study drug LY3857210 in the brain measured by positron emission tomography (PET) with the radioligand \[18F\]-LY3818850 in healthy participants. The safety and tolerability of LY3857210 will also be evaluated. The study will last up to approximately 6 weeks for each participant and may include up to four visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or female participants as determined by medical evaluation
* Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive)
* Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential

Exclusion Criteria:

* Have contraindications to undergoing magnetic resonance imaging (MRI) examination including but not limited to implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips, and other medical implants that have not been certified for head MRI
* Have clinically significant findings on the screening MRI scan, as judged by the investigator
* Suffer from claustrophobia and would be unable to tolerate the confined spaces of MRI or PET camera
Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

Compare two band and loop space maintainers made from two tooth colored materials; Polyetherethherketone (PEEK) and monolithic Zirconia (BruxZir) as regards to:

* Clinical performance of space maintainers in terms of frequency of debonding or fracture of the appliance and health of adjacent gingiva during a one-year follow up.
* Wear of the opposing teeth.

After extraction of the mandibular first primary molars in both mandibular quadrants, impressions will be taken with intraoral scanner. Then, it will be sent to the CAD/CAM laboratory to construct functional band and loop space maintainers using PEEK and monolithic zirconia 'BruxZir' blocks with proper shades.

After the fabrication of the space maintainers of both sides, they will be cemented with resin luting cement containing MDP monomer. Photographs will be taken after cementation for the space maintainers and the patient will be informed and educated about the oral hygiene measures. The parents will also be inquired to call if any discomfort, debonding or fracture of the appliances happens.

Eligibility Criteria:
Inclusion Criteria:

* Clinical inclusion criteria:

  * Children requiring bilateral extraction of mandibular first primary molars or those with previously extracted molars no more than 6 months prior to intervention (11) .
  * Existence of teeth on the mesial and distal side of edentulous area.
  * Angle's Class I molar relationship and/or flush terminal/mesial step primary molar occlusion

Radiographic inclusion criteria:

* No periapical and/ or furcural pathological condition related to abutment teeth.
* Presence of tooth germ of the succeeding tooth (mandibular first premolars).
* Presence of more than 1 mm of bone overlying the successor tooth germ

Exclusion Criteria:

* Carious abutment teeth requiring pulp therapy.

  * Carious abutment primary teeth requiring a full coverage restoration.
  * Patients with history of bruxism or/and clenching.
  * Patients with medical, intellectual or physical disabilities.
  * Patients with abnormalities as posterior cross-bite, open bite, and deep bite