cyrilzakka/clinical-trials huggingface dataset:
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device

Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples.

Although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy.

The aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.

Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples.

Although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy.

The aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.

Main objective is to evaluate the bone fusion time in arthrodesis performed with the Kerifuse shape memory implant.

Secondary objectives are :

* to evaluate the fusion rate and its associated healing time
* to evaluate patient satisfaction, including aesthetic aspect
* to assess overall hand function
* to evaluate the radiological evolution of the KeriFuse® implant and its implantation site
* To evaluate the radiological evolution of the arthrodesis angle between the post-operative situation and the final fusion position

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant

Exclusion Criteria:

* Pregnant or breastfeeding patient
* Patient with an intellectual disability and who therefore cannot follow the surgeon's instructions
* Patients with contraindications to surgery
* Patients with acute or chronic, local or systemic infections
* Patients with sensitivities or allergies to device components (Nickel, Titanium)
Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis

Primary Objective:

* Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.

Secondary Objective:

* Assess systemic exposure of SAR113945 following intra-articular delivery.

The total study duration per subject ranges from 4 to 20 weeks broken down as follows:

* screening within 4 weeks before dosing,
* follow-up of 4 weeks (28 days) after the single dose of study medication,
* prolonged by a maximum of 12 weeks if plasma PK level \> Limit Of Quantification (LOQ) at Day 28.

Eligibility Criteria:
Inclusion criteria:

* Male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having:

  * X-ray or Magnetic Resonance Imaging (MRI) evidence for Kellgren Lawrence Grades II./III joint space narrowing and osteophyte formation,
  * Western Ontario MacMaster (WOMAC) score ≦ 72,
  * American College of Rheumatology (ACR) Clinical and Radiographic criteria for osteoarthritis.

Exclusion criteria:

* Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Principal Investigator, could potentially put the patient at increased risk.
* Secondary osteoarthritis.
* Moderate/severe renal impairment.
* Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) \> 3 Upper Limit of Normal range.
* Intra-articular injection within 3 months.
* Presence of local skin abnormality at the affected knee joint.
* Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol or metamizole as analgesic.
* Any Investigational Product within 3 months.
* Any patient unlikely to comply with the requirements of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients

Medical Products Agency

* A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure.
* The study has an adaptive design. In the 1st dose group the planned number of randomised patients is 24. The tentative number of randomised patients in the optional 2nd dose group is 12, 24 or 36 and thus a total maximum of 60 patients will be randomised in the study.

Eligibility Criteria:
Inclusion Criteria:

* male or postmenopausal female, aged 20 to 80 years inclusive,
* clinical indication for catheter ablation of atrial flutter,
* history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study,
* sinus rhythm at randomisation,
* adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline,

Exclusion Criteria:

* cardioversion within 14 days before randomisation,
* history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures,
* QTcF \>450 ms or \<350 ms measured in sinus rhythm at randomisation,
* history and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia (50 beats per minute or less) at randomisation,
* personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (\>30 s) monomorphic ventricular tachycardia.
Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .

Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer with histological proof
* Measurable disease according RECIST 1.1
* Age ≥ 70 years
* ECOG ≤ 1
* Biological values Haemoglobin ≥ 9 g/dL, PNN ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5N, ASAT, ALAT et PAL ≤ 2,5N (≤ 5N if hepatic metastases), lipase ≤1,5N, TP≥ 70%, Creatinine clairance ≥ 30 mL/min
* Patient without response to 5FU chemotherapy or anti-vegf treatment or anti EGFR treatment (if RAS wild-type), in progression during this treatment or treatment stopped because of toxicities
* Geriatric Questionnaires answered
* Life-expectancy ≥ 3 months
* Informed Consent Signed

Exclusion Criteria:

* Not able to swallow tablets (crushed tablets are not allowed)
* Previous treatment with regorafenib or other multikinase treatment
* Other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated
* Radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion
* Toxicity \> grade 1 not resolved with previous treatment
* Major surgery in the 28 days before the inclusion
* Non cicatrized injury, ulcer or bone fracture
* Congestive Cardiac insufficiency classe \>2 (NYHA)
* Unstable angor in the last 3 months
* Myocardial Infraction in the 6 months before inclusion
* HTA not controlled
* Pheochromocytome
* Arterial or venous thromboembolism in the past 6 months
* Infection of grade \> 2
* VIH infection
* B or C hepatitis necessiting a specific treatment
* Cirrhosis
* Suspicion of brain metastasis or brain metastasis
* Haemorraghe ofgrade \>3 in the last weeks
* Symptomatic Pulmonary fibrosis
* Proteinuria \> grade 3
* Malabsorption
* Allergy know to the treatment or to one similar treatment or to one treatment component
* Systemic anti-cancer drug during the study or the the last 4 weeks
* Concomitant treatment with CYP3A4 inhibitor or inductor or with UGT1A9 inhibitor
* Social, psychological or medical condition which can interfere with the study participation
Investigation of the Effects of Frailty and Sarcopenia on Postoperative Recovery and Complications in Geriatric Patients

After obtaining ethical approval, 42 patients with American Society of Anesthesiologists (ASA) scores I-III who were scheduled for surgery under general anesthesia were included in our prospective study. Patients were monitored in the preoperative preparation room in the operating room and frailty was assessed using the FRAIL scale and sarcopenia was assessed using the STAR ratio. The thickness of the rectus femoris and vastus intermedius muscles of the patients was measured and recorded by ultrasonography. Thigh lengths were measured and recorded. Rectus Femoris/Thigh Length (RF/B), Vastus Intermedius/Thigh Length (VI/B), and Total Muscle Thickness/Thigh Length (T/B) were calculated and recorded. Patients were followed up according to the Modified Aldrete Score after surgery in the anesthesia recovery unit, and the time to reach 9-10 points was recorded, and the time to leave the recovery unit was recorded. Postoperatively, complications were followed up according to the Clavien-Dindo Classification, and discharge times from the hospital were recorded.

Frailty is a clinically identifiable state of heightened vulnerability resulting from age-related declines in physiological systems and functions, leading to impaired resilience to stressors. Frailty is highly prevalent among the elderly and is associated with an increased risk of falls, disability, hospitalization, and mortality. Magnetic resonance imaging (MRI) and computed tomography (CT) are considered the gold standard for sarcopenia diagnosisCT is also limited due to radiation exposure and similar logistical constraints. In contrast, ultrasonography (USG) is portable, cost-effective, and can be performed at the bedside without radiation exposure.

Using high-frequency ultrasound probes, peripheral muscle tissues and their dimensions can be rapidly assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients over 60 years of age who are undergoing colorectal malignancy surgery under general anesthesia
* patients willing to participate in the study
* Patients with ASA score I-III

Exclusion Criteria:

* Patients with Parkinson's disease,
* Alzheimer's disease,
* history of cerebrovascular events,
* neuromuscular disease,
* cognitive dysfunction,
* severe liver disease,
* severe heart disease,
* impaired cooperation due to kidney disease,
* emergency and trauma patients,
* patients with bilateral lower extremity amputations
Trial of SAVVY Vaginal Gel and HIV in Nigeria

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 year old women
* HIV negative
* More than one sexual partner in past 3 months
* Average 3 coital acts per week
* Willing to use vaginal gel and condoms for 12 months

Exclusion Criteria:

* HIV positive
* Pregnant
Procellera and Negative Pressure Therapy for Acute Wounds

The purpose of this study is to determine if Procellera speeds wound healing. The study will examine colonization (bacterial growth), pain and pain medication and reduced cost of care by using Procellera (an antimicrobial agent) under Negative Pressure Therapy placed on the wound after abdominal wall surgery. Procellera is a single layer dressing that helps to kill germs that cause infections. Negative Pressure Therapy is a vacuum device with a sponge that is placed in your wound to help heal the wound faster.

The study will consent 30 patients undergoing surgery through the abdominal wall and the skin incision will intentionally be left open. Subjects will be randomized using a random number generator. Each number will be placed in an envelope numbered 1-30. Arm 1 will be even numbers and Arm 2 will be odd numbers. A researcher not affiliated with the study will generate the numbers and place them in the envelopes. Arm 1 will place fifteen subjects on Negative Pressure Therapy Only and Arm 2 will place fifteen subjects on Negative Pressure and Procellera. Arm 1 (Negative Pressure Only) will have their dressing changed 3 times per week which is the standard of care for Negative Pressure Therapy. Arm 2 (Negative Pressure Therapy and Procellera) will have their dressing changed every 5 days. Arm 1 and 2 will have a tissue specimen taken on the 5th day only. The tissue will be taken from debrided material and sent for culture. The Negative Pressure Therapy Sponge, which is discarded after each dressing change, will be collected, lavaged with saline and the cells will be examined for macrophage function and the wound fluid will be tested for inflammation response. Photographs, wound measurements, pain scale and pain medication will also be completed at each dressing change. We will check the progress of the wound along with your surgeon during the subject's 30 day surgical follow up in the surgeon's office. The wound will be measured (if not healed), photograph's taken and their pain level assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old that are undergoing abdominal wall surgery

Exclusion Criteria:

* Below 18 years old and not having abdominal wall surgery
The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy

A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Infants with diagnosis at birth of HIE

Exclusion Criteria:

* none
Tailored Health Literacy Follow-up in Cancer

Health literacy refers to personal and relational factors affecting a persons ability to aquire, understand and use health information and health services. In a need assessment study, it was found that there is a need to focus on health literacy factors in the follow-up of people with cancer in the health care services.

Thus, this project evaluate the effect of a health literacy intervention in cancer. The intervention provides patients with nurse-led tailored follow-up by phone/digital/personal meetings that addresses their individual HL needs, particularly those needs that impact their quality of life, symptom burden, self-management, and health economic costs. Our main goal is to improve the patients' health literacy, with secondary goals of improving their quality of life, symptom burden, and self-management, and reducing their health care costs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer
* Above 18 years old
* Receiving treatment at the main intervention hospital

Exclusion Criteria:

* Not diagnosed with cancer
* Not above 18 years old
* Not in treatment at the intervention hospital
Effectiveness of Standard Therapy of Acne Vulgaris

This study was to evaluate the effectiveness of standard therapy for acne vulgaris (AV) based on the clinical practice guidelines (CPG) in Indonesia. The main questions it aims to answer were:

1. How is the clinical characteristics of patients with AV in dr.Cipto Mangunkusumo Hospital?
2. How is the effectiveness of standard therapy for AV based on the CPG in Indonesia in reducing the number of non-inflammatory, inflammatory, and total lesions and degree of acne severity?

The clinical pratice guideline (CPG) used for analysis was CPG by dr.Cipto Mangunkusumo Hospital 2017 in line with the date of patient visit. Data of 724 patients with AV in dr.Cipto Mangunkusumo Hospital as recorded in the medical records were assessed for eligibility. Data of 3-month-follow-up data of included subjects were collected and analyzed.

Objective: To evaluate the effectiveness of standard therapy for acne vulgaris (AV) based on the guidelines in Indonesia Design: An analytical retrospective observational study conducted from April 2023 through July 2023 using medical records of new acne patients between 2017 to 2019 from Dr. Cipto Mangunkusumo National Central General Hospital. A total sample of patients with AV who received standard therapy for acne vulgaris based on the guideline by Dr.Cipto Mangunkusumo Hospital in 2017 and not associated with systemic diseases or drugs were included. Patients were classified into mild, moderate, or severe acne using Lehmann grading system. Primary outcomes were changes in the number of non-inflammatory, inflammatory, and total lesions, and the proportion of acne severity after 3 months of therapy.

Eligibility Criteria:
Inclusion Criteria:

* New patients with acne vulgaris in the year 2017 to 2019
* Complete medical record data of 3-month follow-up, including data of: name, medical record number, sex, age, job, level of education, visit date, number of non-inflammatory, inflammatory, and total acne lesions, diagnosis of acne vulgaris based on Lehmann grading system
* Acne treatment based on clinical practice guideline by dr.Cipto Mangunkusumo Hospital 2017

Exclusion Criteria:

* Follow-up data less than 3 times in 3 months
* Incomplete medical record
* AV diagnosis without data on severity
* History of systemic diseases associated with acne such as polycystic ovarian syndrome and Cushing syndrome
* History of allergy with one or more standard acne therapy based on the clinical practice guideline
* Received acne therapy not aligned with clinical practice guideline by dr.Cipto Mangunkusumo Hospital
Neuman Systems Model and Infertility Stress

In this study, it is aimed to determine the effect of Neuman Systems Model based nursing approach on stress an coping with stress for women received intrauterine insemination (IUI) treatment. The study has been planned as a single blind experimental study in pretest-posttest design with randomized control. Sample group is going to be chosen from women who have taken IUI treatment in Ankara University Fertility Diagnosis, Treatment, Research and Application Center. Sample size of the study has been determined as 72 such that intervention=36 and control=36. While gathering data, personal information form, The COMPI Fertility Problem Stress Scales and The COMPI Coping Strategy Scales are going to be used. In the scope of the study, four interviews with women in intervention group are going to be done during IUI treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Getting a diagnosis of primary infertility
2. Volunteering to participate in the study
3. Being over the age of 18
4. Taking IUI treatment
5. Not being diagnosed with a chronic disease
6. Not being diagnosed with a psychiatric illness
7. Do not have a problem that can interfere with written and verbal communication.

Exclusion Criteria:

1. To want to leave the study,
2. Cancellation of treatment.
Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance.


Eligibility Criteria:
Inclusion Criteria:

* Visual field defects after brain damage
* lesion age above 6 months
* documented brain lesions due to ischemic stroke, hemorrhage or tumor demonstrated by computer tomography or by magnet resonance imaging

Exclusion Criteria:

* hemispatial neglect
* complete blindness
* severe psychotic diseases
* serious drug abuse
* chronic degenerative diseases (dementia, multiple sclerosis)
* severe motor impairments
* noticeable low intelligence influencing proper comprehension of diagnostic and training instructions
* considerable impaired vision (visual acuity below 0.1 generated by amblyopia, opacity of cornea or lens, maculopathy and other retinal diseases where vision impairment is expected in the next month (e.g. subretinal neovascularisation, retinitis pigmentosa, diabetic retinopathy)
* inability to fixate due to central scotoma, pathological nystagmus or other forms of fixation disabilities
A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma

This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety \& tolerability of noscapine HCl in patients with advanced multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

* Advanced Multiple Myeloma.
* Progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (iMID), one alkylator, and bortezomib (VELCADE®).
* ECOG performance status of either 0 or 1.

Exclusion Criteria:

* Prior chemotherapy with antimicrotubule agents
* Metastasis involving the brain or spinal cord
* Clinically significant lung or heart disease
* Abnormal electrocardiogram

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Text Messaging for Smoking Cessation in College Health Clinics

This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college.

The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 through 24 years
* Enrolled as a full/part time college student
* A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke every day or some days)
* English-speaking
* Interested in quitting
* Have a cell phone for personal use with an unlimited text messaging plan.

Exclusion Criteria:

* History of hypersensitivity/allergy to nicotine patch;
* Serious arrhythmias - History of heart disease (myocardial infarction, severe chest pain, or coronary artery disease)
* Current pregnancy/breastfeeding/plan for pregnancy