cyrilzakka/clinical-trials huggingface dataset:
Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments

Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments.

Eligibility Criteria:
Inclusion Criteria:

* Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
* Subjects willing to return for follow-up evaluations

Exclusion Criteria:

* Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
* Severe OA deformation (FTA: \>185 degrees or \<175 degrees)
* Active Infection (or within 6 weeks after infection)
* Sepsis
* Osteomyelitis
* Any type of implant is inserted in the affected side of lower extremity
* Hip disease on the affected side
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* diagnosed Osteoporosis or Osteomalacia
* Metabolic disorders which may impair bone formation
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.
Z8 OCT-controlled 2D vs 3D LASIK

The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications and how it correlated to visual experience and quality of life responses during the early postoperative period.

It has been postulated that it is possible with the Ziemer Femtosecond LDV laser system to create reproducible flaps in terms of thickness and predictability. The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications. Patient-reported outcomes are increasingly incorporated into clinical trials as they provide access to valuable information on the physical experience of the patient during and after the treatment. A questionnaire will therefore also be introduced in this study to evaluate how well self-reported pain, visual experience, and quality of life responses are correlated with flap geometries in both groups during the early postoperative period. The study holds direct medical benefit to the patient in this that they received an immediate improvement in his/her unaided vision. Moreover, the patient's participation contributes to the medical knowledge about the use of femtosecond lasers for refractive surgery, in particular in view of the use of intraoperative OCT visualization tools. The patients will gain access to the newest technology available for refractive surgery namely a low pulse energy high-frequency femtosecond laser.

Eligibility Criteria:
Inclusion Criteria:

Key inclusion criteria as described by the German Commission for Refractive Surgery (KRC) are:

* The recommended range of application for the correction of myopia is up to -8.00 D and for the correction of astigmatism up to 5.00 D.
* The limited for LASIK correction of myopia is up to -10.00 D and correction of astigmatism up to 6.00 D. If myopic astigmatism is to be corrected, the values for myopia and astigmatism must be added together.
* The recommended range for correction of hyperopia is up to 3.00 D. Up to 4.00 D is the range of limited application for hyperopia.
* Age ≥18 years with stable eyesight for over 12 months.

Exclusion Criteria:

Key exclusion criteria as described by the German Commission for Refractive Surgery (KRC):

* preoperative corneal thickness less than 480 μm
* predicted stromal thickness under the flap after ablation of less than 250 μm
* chronic progressive corneal disease and forme fruste keratoconus
* surgery before the age of 18 years
* symptomatic cataract
* Glaucoma with a marked loss of visual field
* Exudative macular degeneration.
* Concurrent participation in another ophthalmological clinical study

Exclusion criteria irrespective of the KRC criteria:

* Undergone former eye surgery
* Contact lens wear within the two weeks prior to commencement of preoperative measurements
Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer

This study has been designed to utilize already obtained biopsy specimens for investigation of the utility of a new, non-invasive optical diagnostic technique. The study will allow a careful correlation between the Optical coherence tomography findings and conventional histology.

Optical coherence tomography is a non-invasive diagnostic technique that can provide information about tissue abnormalities, change in structure of an organ. This technique uses a near-infrared diode to emit light that can produce images of the specimen under investigation without causing damage or alterations.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years and older
* Having procedure of endobronchial, transbronchial, and / or pleural biopsy

Exclusion Criteria:

* Currently participating in any other investigational drug or device evaluation.
* Currently taking drugs that are sensitive to light.
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.

This is a Phase 1/1b, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose \[RP2D\] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).
* Received prior standard therapy appropriate for tumor type and stage
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Primary central nervous system (CNS) tumors
* Active, untreated brain metastases
* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
* History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy

Other inclusion/exclusion criteria may apply.
Multi-omics Study of Clinical Endpoints in CHD

This study aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences. It will enroll approximately 4000 coronal heart disease patients aged between 18 and 80 years in mainland China and follow-up for at least 1 years. Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected . The principal clinical outcomes of the study consist of ischemia attack , cardiac death, renal injury,and myotoxic activity.

The study is a multicenter prospective cohort study, aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences.The genomic genotype, DNA methylation and metabolome of 1000 patients with coronary heart disease were determined using illumina high-density genotyping chip, high-throughput sequencing and high-resolution mass spectrometry. Blood exposures of statins and metoprolol and its metabolites was determined by UPLC-MS/MS.

The biological network using cross-omics analysis was reconstructed to identify potential causative key genes, bacteria, and endogenous metabolite targets that cause differences in individual responses. A machine identification algorithm selecting clinical factors and multi-omics targets was used to establish a predictive mathematical model.

A multi-center clinical cohort of 3000 coronal heart disease patients was used to verify the effects of various levels of omic targets on drug blood exposures, efficacy and toxic side effects. A comprehensive model based on multi-target combination of individualized drugs was constructed, and the predictive effect was clinically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-80 years
* Chinese Han patients with coronary artery disease
* inpatients undergoing coronary angiography or percutaneous coronary intervention

Exclusion Criteria:

* renal insufficiency (defined as serum creatinine concentration \> 2 times the upper limit of normal \[230 μmol/L\], renal transplantation or dialysis)
* hepatic insufficiency (defined as serum transaminase concentration \> 2 times the upper limit of normal \[80 U/L\], or a diagnosis of cirrhosis)
* pre-existing bleeding disorders
* being pregnant or lactating
* advanced cancer or haemodialysis
* history of thyroid problems, and use of antithyroid drugs or thyroid hormone medication
* incomplete information about cardiovascular events during follow-up
Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event

This study aimed to assess the longitudinal changes in triceps surae muscle-tendon architecture to an ultra distance trail running. Experienced trail runners (N=55, 78% men, age: 45.2 \[13.5\] years) participated in a 156-km trail run (6000m climbing) consisting in six 26-km laps. The resting architectural properties of triceps surae muscle-tendon were measured using ultrasound imaging for Achille tendon cross-sectional area (AT CSA), medial gastrocnemius muscle pennation angle, thickness, length and fiber length. Measurements were performed the day before the race (Baseline), at 52-km (T1), at 104-km (T2), at 156-km (T3) and 12 hours after the race (H12).


Eligibility Criteria:
Inclusion criteria

* Experienced runners voluntarily participating in the Trail Scientifique de Clécy (156 km/6000 D+)
* Participants who had already completed 2 ultratrail races (+160 km and -160 km), at least one of them in the past 24 months; the participants had to justify their events and rankings
* Participants affiliated with a social security system or those who were a beneficiary of such a system
* Participants who could speak and read the French language
* Participants with the ability to physically participate in the ultraendurance race
* Participants with the ability to provide written consent for participation in the study

Exclusion criteria

* Participants with cardiac or extracardiac contraindications to intense physical activity
* Participants who had run a mountain ultramarathon (160 km) after September 2, 2021
* Pregnant or breastfeeding women
* Minor participants
* Participants included in another biomedical research protocol during this study
* Participants with recent muscular and orthopedic injuries, limiting running for \<15 days
* Participants with a history of ankle joint surgery (eg, arthrodesis)
* Participants with a history of foot or ankle surgery
* Participants with lower-limb pathology or trauma
A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer

To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy.
* Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions.

  1. Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx
  2. Postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx
* Patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Patients who are able to hold fluid in the mouth
* Patients who are able to swallow the investigational medicinal product (IMP)
* Patients expected to survive for at least 3 months
* Patients who have given written informed consent in person
* Patients who can stay at or visit the hospital for scheduled examinations and observations
* Patients who are able to take contraceptive measures to avoid pregnancy of the patient or their partner from the time of informed consent until 4 weeks after completion of IMP administration

Exclusion Criteria:

* Patients with primary malignant tumors other than head and neck cancer.
* Patients with symptomatic viral, bacterial, or fungal infection
* Patients with serious renal impairment
* Patients with distant metastasis
* Patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc)
* Patients with any of the following laboratory test results:

  1. Neutrophil count: \<1500 L
  2. Platelet count: \<75000 L
  3. Hemoglobin: \<10.0 g/L
  4. Aspartate aminotransferase (AST): \>3 times the upper limit of the reference value at the trial site
  5. Alanine aminotransferase (ALT): \>3 times the upper limit of the reference value at the trial site
  6. Serum bilirubin: \>1.5 times the upper limit of the reference value at the trial site
  7. Serum albumin: \<3.0 g/dL
  8. Serum creatinine: \>1.5 the upper limit of the reference value at the trial site
  9. Creatinine clearance : \<30 mL/min
* Patients complicated with autoimmune disease
* Patients requiring continuous systemic administration of glucocorticoid
* Female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant
* Patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy
* Patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds
* Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial
Cabozantinib and Pembrolizumab in Metastatic Pancreas

This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pancreatic ductal adenocarcinoma
* Evidence of progression or intolerance to previous standard of care pancreatic cancer systemic or locoregional therapies
* Patients must have adequate organ function

Exclusion Criteria:

* Chemotherapy or other locoregional anti-tumoral therapies performed within 28 days of study treatment initiation
* Received palliative radiation therapy within 2 weeks or any other radiation therapy within 4 weeks of start of study intervention
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation
* Has a diagnosis of immunodeficiency (autoimmune disease) or is receiving chronic systemic steroid therapy
* Clinically significant cardiovascular disease
* Uncontrolled hypertension
* Inability to swallow tablets
Locked-in Syndrome Caused by Pulmonary Arteriovenous Malformation: A Case Report

In this case, we report a case of atresia syndrome (LIS), a serious neurological disease caused by pulmonary arteriovenous fistula (PAVM). We present a previously healthy middle-aged woman who developed atresia syndrome after severe pontine infarction due to basilar artery occlusion due to undiagnosed arteriovenous malformation. This report reviewed the medical history, post-admission examination and related literature, and concluded that PAVM should be considered as the cause of implicit stroke, especially in young patients with right-to-left shunt, and should be actively treated.


Eligibility Criteria:
Inclusion Criteria:

* A case of Locked-in syndrome due to pulmonary arteriovenous malformation

Exclusion Criteria:

* Patients or family members objected to the study
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan

A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 40
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypertension of hypotension
The Effect of Child Abuse and Neglect Prevention Program on Awareness Levels and Child Abuse Potential of Pregnant Women

The aim of this study is to determine the effect of the Child Abuse and Neglect Prevention Program (CANPP) based on Social Cognitive Theory (SCT) on the awareness levels and child abuse potential of pregnant women. This randomized controlled study was conducted between July and December 2022 in a family health center of Aydin/Turkey with the participation a total of 30 pregnant women, who were then distributed into two groups as 15 experiment group and 15 control group pregnant women.The participants in the experiment group were applied SCT-based CANPP whereas no intervention was applied to the control group. Research data were collected before the intervention, one month after the intervention, and three months after the intervention using the Pregnant Data Collection Form, Child Neglect and Abuse Awareness Scale for Parents (CNAASP) and Child Abuse Potential Inventory (CAPI). Chi-Square and Fisher exact tests, independent groups t-test and repeated measures ANOVA test were used in the statistical analysis of the research data.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who agree to participate in the study
* are 18 years of age or older
* who can read and understand Turkish
* who have either a smart phone or a computer
* are between 28+0 and 33+0 weeks of pregnancy

Exclusion Criteria:

* Pregnant women with high risk pregnancy
* who have visual or auditory problems
* who have been diagnosed with mental disorders.
Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System

Correlation between colposcopist findings and digital cervicography employing Gynescope system

Up to 30 women that will be referred for colposcopy examination at the standard indications will also undergo a colposcopy examination of the cervix by a gynescope. The physicain performing the optical test will record the findings in accordance with the International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Categorical variable will be included in every record. At later stage, the images obtained by the cervicography will be evaluated and recorded in accordance with the IFCPC terminology. Correlation between the categorical findings in both assesments will be compared. The correlation measure will be performed by Kappa test according to the categorial result of both measurements.

Eligibility Criteria:
Inclusion Criteria:

- Patients reffered for colposcopy

Exclusion Criteria:

Patient refusion
Intrathecal Hydromorphone for Labor Analgesia

This study will investigate the dose of hydromorphone which will relieve the pain of women in labor when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

After the intrathecal injection is given and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients
* Labor
* Desires pain relief

Exclusion Criteria:

* Any comorbidities other than obesity
The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease

The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's disease patients.

Recently, a biomechanical wedge system was developed for gait and balance training among patients suffering from gait disorders. The APOS system (APOS Medical \& Sports Technologies Ltd, Hertzeliya, Israel) applies special semispherical shoes, with individually adjusted implants, to improve age- and disease-related loss in muscle strength and neuromuscular control. The semispherical rubber devices that are placed on the soles of the shoes at the hind-foot and mid-foot can be moved medially, laterally, forwards and backwards. The system can be individually adjusted in order to optimally balance loading and re-train postural control during gait. An additional advantage of this treatment approach is the extraordinary compliance. The system is easily adjusted, maintained, and allows safe gait training.

After randomization, all subjects will be fitted with the APOS system, These shoes alter the dynamic balance during all gait cycle phases, adjusting the center of gravity and training postural control.

The precise location of the two wedges is adjusted individually by expert trainers using standardized protocols. Subjects in the intervention group will receive a proper wedge; subjects in the sham group will receive an almost flat wedge that lacks the proper biomechanical characteristics. However, both shoes and wedges will look similar. All subjects will be instructed to start gradually, with a goal of reaching 30 minutes of in-home walking while wearing the special training shoes. As an extra pre-caution, all subjects will be asked to walk with the shoes only in the presence of a caregiver, spouse or other family member during the first month. Before moving to more independent training, subjects will be checked for safety.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Stage 2-3 Hoehn \& Yahr

Exclusion Criteria:

* Peripheral neuropathic pain
* Dementia
* Severe orthopaedic condition
* c.v.a
* Hearing or vision loss
* Usage of walking aid