cyrilzakka/clinical-trials huggingface dataset:
Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis

In a society based on the use of everyday tools and objects, the loss of function of one or both thumbs due to Rhizarthrosis can drastically reduce the quality of life. Many patients are refractory to preservative treatments.Therefore, multiple arthroplasty techniques were developed.

Trapeziectomy, with or without tendon interposition, gives very good results in terms of pain, function or force. However, it can result in a reduction of the size of the column of the thumb, therefore leading to a loss of force.

Replacement of the trapezo-metacarpal joint with prosthetic material is also proposed and has the advantage to avoid the reduction of the thumb column. Several models are available, mono or bipolar, with a conical or hemispherical cup. Another option is the placement of implants. They were first used when a partial trapeziectomy was possible to counter the collapse of the column and are made of different materials such as metal, silicone, ceramic, pyrocarbon , and gelfoam.

The bioabsorbable poly-LD-lactide implant (PLDLA) is a relatively new possibility for the reconstruction of small joints. Studies have previously revealed that the PLDLA implant is biocompatible and represents a good alternative to arthroplasty by tendon interposition in the reconstruction of the trapezo-metacarpal articulation with osteoarthritis.

In this study, the investigators will investigate the long term effects (1 year after placement) of the Regjoint, a poly-LD-lactide implant (PLDLA).


Eligibility Criteria:
Inclusion Criteria:

* Adults\> 18 years
* Patients having had a trapeziectomy for more than one year, because of chronic Rhizarthrosis defined by pain and Radiographic Signs, aka articular pinching, bone erosion and potential subluxation of the trapezo-metacarpal joint.

Exclusion Criteria:

* Surgery less than 1 year ago.
* Concomitant pathology of the thumb or wrist (Recent injury or trauma, Quervain tenosynovitis, Carpal tunnel syndrome, Dupuytren, jumping finger).
* Trapeziectomy secondary to distal prosthesis and scaphoidectomy.
Phase II Study of Taxotere in Combination With Exisulind in Non-Small Cell Lung Cancer (NSCLC) Patients

The purpose of this study is to determine if the combination of Taxotere and exisulind is an effective and safe treatment for patients with advanced NSCLC who have failed a prior platinum-containing regimen.


Eligibility Criteria:
Inclusion Criteria:

Histologically documented advanced cancer or advanced platinum-refractory non-small cell lung cancer. Platinum refractory defined as progressive disease during a platinum regimen or within 6 months following treatment.

Negative serum pregnancy test, if fertile female. Have not taken sulindac (Clinoril®) on regular basis for any indication for one week prior to enrollment and willing to remain off of sulindac for the duration of the study.

\> 18 years or of legal age. Male patients, or non-pregnant and non-lactating female patients either using adequate birth control (oral contraceptives or Provera), surgically sterile or post-menopausal.

Willingness to remain off chronic NSAIDs (with the exception of ibuprofen, naproxen, or aspirin) for duration of the study. Low dose aspirin for cardiovascular prevention is acceptable.

No treatment with any other chemotherapy or radiotherapy within 2 weeks prior to entering the study.

Exclusion Criteria:

Any condition or any medication which may interfere with the conduct of the study.

Known hypersensitivity to sulindac (Clinoril®) or taxanes. Use of an investigational medication or device within one month of initiating study therapy.
Intraoperative Methadone in Children Undergoing Surgery

A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery.

Treatment of postoperative pain is a challenge in younger children undergoing outpatient surgery. After discharge parents must assess pain intensity and administer analgesics, including opioids, as per needed. It has been shown that parents often hesitate to administer analgesics. The result is unrelieved pain that negatively affects the whole family and increases the risk of unscheduled contacts with healthcare professionals.

In children, methadone has shown a half-life of 19,2 +/-13,6 hours. Regarding outpatient surgery, methadone is an opioid with unique pharmalogical properties that may be advantageous. A single-dose of this long acting opioid administered perioperatively could provide a stable analgesia and potentially reduce the need for shorter-acting opioids in the PACU and at home.

Eligibility Criteria:
Inclusion Criteria:

Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital.

Exclusion Criteria:

* Age =/\> 5 years at the date of operation
* Born preterm (Before gestational age of 37 weeks)
* Congenital heart disease
* Previous scrotal surgery
* Laparoscopic operation
* American Society of Anaesthesiologists (ASA) physical status lll, IV or V
* Allergy to study drugs
* Preoperative daily use of opioids
* Parents with inability to provide informed consent
* Severe respiratory insufficiency
* Acute abdominal pain
* Severe kidney insufficiency
* Treatment with rifampicin
Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI

This study will enroll people with SCI who have spasticity and some ability to walk. The goal is to understand if standing on a platform and receiving WBV results in decreased spasticity and improved walking ability. Published article is available (PMID: 29959653)

Phase 1 of this study has been successfully completed. The results of Phase 1 indicate that a single session of WBV lasting for a total of 6 minutes (delivered in eight 45-sec bouts) at a high-frequency (50Hz) was associated with the largest decrease in spasticity (as measured by the pendulum test). The goal for Phase 2 is to determine whether longer doses of WBV result in greater reductions in spasticity as well as improvements in walking ability. Two different doses of WBV, a short dose and a long dose, will be tested.

Eligibility Criteria:
Inclusion Criteria: have spinal cord injury of at least 6 months duration; be between the ages of 16 - 72 years old; be able to sit at the edge of the mat without the assistance of another person; be able to tolerate standing; have at least mild spasticity affecting the lower extremity muscles; be able to understand and provide own consent; you may participate if you use prescription medications, including baclofen pump for control of spasticity, as the dosage is stable; obtain medical clearance for standing if you have been injured more than 1 year and are not regularly walking or standing.

Exclusion Criteria: progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord; neurologic level below spinal level T12; history of cardiovascular irregularities; problems following instructions; orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
Long Term Sidus PMCF

The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.

The data collected from this study will serve the purpose of assessing safety and performance of the Sidus Shoulder.

Safety: Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).

Performance: Will be determined by analyzing the implant survival, overall pain and functional performances (based on the ASES Patient Questionnaire and range of motion) and radiographic parameters of subjects who received the Sidus Shoulder. Implant survival will be based on removal or intended removal and determined using the observed component years (OCY) model as it is not anticipated that there will be adequate data at the 10 years follow-up to support Kaplan-Meier survivorship analysis. In the instance that there is sufficient data to perform Kaplan-Meier analysis, the analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have previously participated in the Sidus IDE clinical trial.
* Patient must not have undergone revision of the Sidus shoulder.
* Patient must be able and willing to complete the protocol required follow-up.
* Patient must be able and willing to sign the IRB/EC approved informed consent.

Exclusion Criteria:

* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
* Patient did not previously participate in the Sidus IDE clinical trial.
* Patient no longer has Sidus shoulder implanted.
Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis

The purpose of this study is to determine the efficacy of 2 different doses of intramuscular (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in the blood of patients with tropical calcific pancreatitis.

Tropical calcific pancreatitis (TCP) is a form of chronic pancreatitis unique to developing countries. Patients with TCP often have malabsorption leading to nutritional deficiencies. We have noted that vitamin D deficiency is common in patients with TCP. The ideal regimen for supplementing vitamin D3 in chronic pancreatitis remains unclear and there are no previous studies available. High dose oral vitamin D2 has been shown to be ineffective in normalizing vitamin D levels in patients with pancreatic insufficiency due to cystic fibrosis.

Intramuscular (IM) vitamin D3 supplementation in chronic pancreatitis has certain advantages. Firstly, decreased and inconsistent absorption from the intestine is avoided. Secondly, IM vitamin D3 has a long duration of action (6-12 months). The safety of high-dose IM vitamin D3 has been proven in previous studies in healthy individuals. Finally, the injection form is considerably less expensive as compared to oral vitamin D3.

The aim of the current prospective double blind study is to compare 2 regimens of high dose IM vitamin D3 replenishment with oral vitamin D3 in standard recommended doses in normalizing serum vitamin D3 levels in patients with TCP.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of tropical calcific pancreatitis established by history of abdominal pain or diabetes and evidence on ultrasound or CT scan of pancreatic ductal dilatation and intra-ductal stones

Exclusion Criteria:

* History of alcohol intake or any secondary cause for chronic pancreatitis (hypercalcemia, hypertriglyceridemia, biliary tract stones)
* History of hepatic or renal dysfunction or of current intake of drugs such as steroids, anticonvulsant drugs
Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction

This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).

Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute intestinal obstruction

Exclusion Criteria:

* pregnancy;
* peritonitis or strangulation, revealed during primary examination;
* early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)
Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease

This randomized clinical trial (RCT) was aimed to determine the effects of eye masking on sleep quality and tear layer function in patients with dry eye disease. In this regard, a total of 34 patients with dry eye disease aged between 20 to 35 years old will be participated. They will be randomly divided into case and control (n=17) groups. Patients in the case group will be instructed to wear the eye mask as long as two weeks and the controls will be recommended to not wear it at the same time. Afterwards, the eye mask application will be cross- over for the next 2 hours between the two groups. Tear layer will be investigated in baseline and repeated in both follow- ups of weeks 2 and 4, either quantitatively and qualitatively, by using Schirmer and TBUT tests. Furthermore, the sleep quality will be checked by the PSQI test.


Eligibility Criteria:
Inclusion Criteria:

* Patients with dry eye disease according to the OSDI test

Exclusion Criteria:

* Patients with eye disease except dry eye
* Patients using systemic and ophthalmic drugs
* Patients using sleeping and sedative pills
Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of CTC

Detecting circulating tumor cells from I-IV stage colorectal cancer patients pre-and post-operatively. Analyzing the morphology and biomarkers of CTCs and builting prognosis predicting model based on the morphology and biomarkers of CTCs. Verifying the prognosis model by the survival data.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years;

Histologically proven colorectal carcinoma (TNM stage I-IV)

R0 resection is possible according to preoperative evaluation

Written informed consent for participation in the trial.

Exclusion Criteria:

* Primary tumor or metastases not able to be removed radically

Receiving any preoperative treatment (Including chemotherapy, radiotherapy and target therapy)

Have other malignant tumors meanwhile

Other previous malignancy within 5 years
Efficacy of Movement Breaks in Real-World Settings

The purpose of this study is to determine the efficacy of performing "exercise snacks" (short movement breaks throughout the day) on various measures of cardiometabolic health.

After being informed about the study and potential risks, all eligible participants who have provided consent will undergo a baseline visit to assess pre-intervention basic anthropometrics, cardiorespiratory fitness, and provide a blood sample. Participants will then be randomized in a 1:1 ratio to one of two groups: 1) Mobility movement breaks (stretching or range of motion exercises); or 2) Cardiovascular movement breaks (designed to raise heart rate). Both groups will be encouraged to perform 3-4 daily movement breaks on at least 3 days of the week with support from an online platform and app that provides video instructions and reminders to complete the movement breaks. After 12 weeks, participants will be asked to return to the lab for the same testing performed at baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Physically inactive (performing \<150 minutes of moderate-to-vigorous intensity aerobic exercise per week, assessed by pre-screening Get Active Questionnaire);
2. Body Mass Index: 18.5-30.0 kg/m2;
3. Not currently diagnosed with or being treated for cardiometabolic disease (e.g., coronary artery disease, diabetes);
4. Not a current smoker;
5. Cleared to engage in physical activity using the Get Active Questionnaire and, if applicable, consultation with a Qualified Exercise Professional;
6. Access to a computer, tablet or smartphone for intervention delivery and tracking

Exclusion Criteria:

1. Chronic health condition preventing participation in exercise;
2. Lack of access to internet connection
A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas

This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.


Eligibility Criteria:
Inclusion Criteria:

* patients \>=3 and \<=21 years of age;
* newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade glioma;
* Karnofsky (if \>16 years) or Lansky (if \< 16 years) Performance Scale of \>=50%;
* adequate organ function.

Exclusion Criteria:

* previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
* uncontrolled infection;
* known DPD deficiency.
Deep Brain Stimulation (DBS) for Parkinson's Disease International Study

To gather data on DBS Therapy effectiveness in different geographic populations.

The purpose of this prospective open label post market study of DBS for PD is to gather data on DBS therapy effectiveness as measured by clinician and patient reported health outcomes data through one year of follow-up in different geographic populations.

Eligibility Criteria:
Inclusion Criteria:

1. Indication of DBS for PD consistent with the country specific approved labeling.
2. Levodopa-responsive Parkinson's disease (UPDRS III ≥ 30% improvement on Levodopa challenge test).
3. Symptoms treatable by medications but not adequately controlled with medications (with persistent disabling symptoms, such as motor fluctuations, dyskinesia).
4. At least 22 years old.
5. Screening cranial MRI, performed within 12 months of entry into the study, that is normal or with a non-significant abnormality that does not present any incremental risks or concerns for the patient as a result of the DBS procedure.
6. Understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements.

Exclusion Criteria:

1. Secondary Parkinson's disease, atypical syndromes.
2. Previous stereotactic functional neurosurgery or ablative therapy (e.g., pallidotomy, subthalamotomy), surgical contraindications related to DBS.
3. Dementia (Mattis Dementia Rating Scale ≤ 130), major depression with suicidal thoughts (Beck Depression Inventory II \> 25), acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigator's medical judgment.
4. Electrical or electromagnetic implant (e.g., Cochlear prosthesis, cardiac pacemaker).
5. Surgical or medical contraindications to DBS surgery or therapy (e.g., uncontrolled hypertension, advanced coronary artery disease).
6. Participation in a drug, device, or biologics trial within the preceding 30 days that may confound the study results.
7. Pregnant female.
Ashwagandha Supplementation for Prevention of Muscle Damage

Ashwagandha is an herbal supplement that has a wide range of benefits related to exercise when supplemented for about 8-12 weeks. This study aims to investigate whether short-term Ashwagandha supplementation can enhance muscle recovery following exercise by measuring muscle strength recovery, swelling, and soreness in the biceps.

The purpose of the study is to determine the effects of Ashwagandha supplementation on recovery from muscle-damaging exercise. Ten to twenty participants will be randomized to receive Ashwagandha supplementation (600 mg/d) or placebo for 10 days. On day 7, participants will perform a muscle damaging exercise session (six sets of concentric and emphasized eccentric repetitions with the biceps). Before and after exercise and at 24, 48, and 72 hours after exercise, isometric muscle strength, muscle swelling (ultrasound), and muscle soreness will be assessed. The investigators hypothesize the Ashwagandha will alleviate symptoms of muscle damage (swelling and soreness) and enhance strength recovery after a bout of muscle-damaging exercise.

Eligibility Criteria:
Inclusion Criteria: male or female, aged 18-35y

-

Exclusion Criteria:

Conditions that may be affected by exercise (determined by "yes" answers to the "Get Active Questionnaire") Pregnant Breastfeeding

Allergies to:

* Dicalcium Phosphate
* Cellulose
* Vegetable magnesium stearate
* Silica
Invitro Maturation of Oocytes for Patients With Polycystic Ovaries

In vitro maturation of oocytes after minimal gonadotropin stimulation in patients with polycystic ovaries, to prevent cases of ovarian hyperstimulation.


Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovaries
* Needing IVF for fertility treatment

Exclusion Criteria:

* Age above 39
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Female assigned at birth
* Pre, peri- or post-menopausal
* Healthy weight (BMI ≥18 and ≤30 kg/m2)

Exclusion Criteria:

* Male (assigned at birth)
* Pregnancy, breastfeeding
* Use of hormone replacement therapies
* Hysterectomy
* Body mass index \>30 kg/m2
* Diagnosed sleep apnea
* Current smoking/Nicotine/Drug use
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications
* Malignant cancer