cyrilzakka/clinical-trials huggingface dataset:
Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft

Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SLPLUS

™ MIA stem within an observation study Study design: prospective, multicenter, observational, noncomparative study Study population: 300 consecutive cases (HA-coated implants), 60 cases per study site. Intervention (if applicable): Implantation of a total hip endoprosthesis Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration. Clinical: Harris Hip Score, HOOS Score, EQ-5D, implant-related complications, revisions Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. In addition, study patients are asked to provide information on their general state of health and the condition of their hip in two questionnaires. These clinical and radiological follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the direct benefit for the patients from the participation in the study is currently not yet foreseeable.


Eligibility Criteria:
Inclusion Criteria:

* Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
* Patient shall be provided with a HA coated SLPLUS™ MIA stem
* Patient has no general medical contraindications regarding the surgery
* Signed informed consent form for the participation in the study
* X-ray examinations are possible
* Patient is willing to participate in the post-operative follow-up program
* Age: 18-75 years

Exclusion Criteria:

* Previous failed hip joint surgery (endoprosthesis) of the side affected
* Previous infections in the joint affected; systemic infections
The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus

The aim of this study is to compare the efficacy of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) and 1Hz rTMS for the treatment of chronic subjective tinnitus. In this single-blind randomized controlled study, patients will be randomly assigned 1:1 to receive two different types of rTMS stimulation.

Tinnitus is a common disorder with a prevalence of 10-25% among adults, which seriously affects the quality of life of patients. Many studies have reported significant efficacy of repetitive transcranial magnetic stimulation (rTMS) for tinnitus, but its optimal stimulation parameters are not clear. Therefore, there is necessary to assess the clinical efficacy and mechanism of different types of rTMS for the treatment of chronic subjective tinnitus through rigorously designed clinical studies.

The study will assess the severity of tinnitus and the mood and sleep status of the patients through several scales and tinnitus psychoacoustic assessment before treatment, after treatment and at follow-up. The primary research hypothesis is that frequency-specific patterned rTMS will be superior to 1Hz rTMS in reducing tinnitus-related distress.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged between 18 and 80 years old.
2. Experiencing persistant subjective tinnitus for at least 3 months.
3. A score of 38 or more on THI.
4. 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
5. Voluntarily participate in the study and sign the informed consent form.
6. Have normal mental status and cognitive function, and be able to cooperate with the research process.

Exclusion Criteria:

1. Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus.
2. History of epilepsy or stroke.
3. Diagnosis of acoustic neuroma.
4. Severe sensorineural hearing loss.
5. Surgically or traumatically implanted ferromagnetic foreign bodies, including but not limited to pacemakers, neurostimulators, prosthetic metal heart valves, aneurysm clips (non-titanium alloy), intraocular metal foreign bodies, cochlear implants, metal prostheses, metal joints, fixed steel plates or steel pins.
6. Patients with active metal foreign bodies (metal implants, dentures, contraceptive rings), insulin pumps, etc., who have been evaluated in detail and are at risk for rTMS treatment.
7. Patients taking vestibular sedatives, antipsychotics, anxiolytics, antiepileptics, and ototoxic drugs.
8. Patients with a recent history of alcohol or drug abuse
9. Bell's palsy
10. Acute ear infection within the last 1 month
11. Inability to cooperate or complete the study process
12. Participation in another clinical trial within the last month.
13. Have any condition that may affect compliance or safety
14. Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.
Supervised Outdoor-Use Test For Sunscreen Products in Adults

To assess the safety of a sunscreen product under supervised outdoor-use conditions


Eligibility Criteria:
Inclusion Criteria:

* Subject must be healthy, males or females between 18 to 65 years of age with no medical conditions of the skin.
* Subjects must have Fitzpatrick Skin Type I, II, III or IV.
* Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.

Exclusion Criteria:

* Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
* Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
* Subjects must not have significantly tanned skin.
Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache

Chronic headache is most often associated with drug abuse and medication overuse headache (MOH) is the main complication of migraine disease results in chronic daily headache. The first phase of treatment consists of drug withdrawal .

The second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use.

The aim of this study is

1. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
2. use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period.

It is a feasibility pilot study in chronic headache with or without medication-overuse. All patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". The subsequent attacks will be treated with NOT from a high-flow concentrator

Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of patients who accepted NOT during the withdrawal phase then to treat attacks.

Secondary endpoints. Efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake).

Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months

Effective : 30 patients


Eligibility Criteria:
Inclusion Criteria:

* Migrainous according to the criteria of the International Headache Society
* Medication-overuse headaches according of the International Headache Society
* No prophylaxis treatment or same prophylaxis treatment from more than one month
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* One or more failed withdrawal treatment
* analgesic treatment for another reason than headache
* Contraindication of normobaric oxygen therapy
* Contraindication of ketoprofen (rescue therapy)
Natural History Study of Patients with HPDL Mutations

This study uses medical records that allow retrospective data extraction of clinical manifestation to assess the natural history of HPDL mutations

A novel mitochondrial disease arises from mutations in HPDL, which codes for 4-hydroxyphenylpyruvate dioxygenase-like protein. The main purpose of this study is to establish a patient registry to gather medical data from consenting HPDL mutation patients worldwide. From longitudinal data, we will be able to figure out the natural history of the disease, and genotype-phenotype correlation. Dry blood spots will be collected to develop biomarkers to understand the disease better.

Eligibility Criteria:
Inclusion Criteria:

* Any individuals diagnosed with HPDL variants
* Clinical diagnosis can include:

  * HPDL-related hereditary spastic paraplegia (HSP)
  * HPDL-related neonatal mitochondrial encephalopathy
  * Spastic paraplegia -83 (SPG83)
  * Neurodevelopmental disorder with progressive spasticity and brain white matter abnormalities (NEDSWMA)

Exclusion Criteria:

* Any known genetic abnormality (other than HPDL mutation)
* Any condition that, in the opinion of the Site Investigator, could put the participant at undue risk and/or would ultimately prevent the completion of study procedures
Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Has undergone primary THA for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia
* Inflammatory degenerative joint disease such as rheumatoid arthritis
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Skeletally immature (less than 21 years of age at time of surgery)
* Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration
A Comparison Between TOF Watch® SX and Tetragraph®

This observational study was designed to assess the agreement between the recently marketed electromyographic neuromuscular blockade monitor Tetragraph® (Senzime, Uppsala, Sweden) and the TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland), an accelerometric neuromuscular blockade monitor frequently used in clinical practice

Before the induction of general anesthesia both monitors will be placed in the same arm. After induction of general anesthesia and before neuromuscular blocking agent administration both devices will be consecutively calibrated and a baseline measurement will be obtained. During the surgical procedure the investigators will monitor neuromuscular function with one of the two devices. Then the investigators will switch the device used as a guide between subsequent patients. The protocol will start as soon as the leading device will register a train-of-four ratio (TOFr) ≥ 0.2. During the protocol a comparison between the two devices will be conducted as soon as the device used as a guide will display a TOFr ≥ 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1. For each of the TOFr reported, we will deliver two subsequent TOF stimulations with the guiding device followed by two TOF stimulations with the other monitor. Both the stimulations delivered by each device and the two consecutive stimulations delivered by different monitors will be conducted 20 sec from one another. Stimulations with the same device will be used to assess intraobserver variability for each methodology, while the second and the third measurements (consecutive stimulations with different devices) will be used to assess agreement between them. The protocol will end when the leading device will show a TOFr ≥ 1.0, or if, at the end of the surgical procedure, acceleromyographic TOFr will be \> 0.9.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Rocuronium bromide use is anticipated for neuromuscular blockade during surgical procedure
* Upper arms will be freely available during the surgical procedure

Exclusion Criteria:

* Known neuromuscular disease
* Known allergy to Rocuronium bromide
* end-stage liver disease
* chronic kidney disease
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride Tablets Under Fed Conditions

Objective:

subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing periods of studies were separated by a washout period of 12 days and 11 days respectively.

Study Design:

Randomized, Two-Way Crossover, Single-Dose, and Open-Label


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines,Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants

A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* All healthy adult participants must be willing and able to follow protocol-specified assessments.
* Healthy based on no clinically significant medical history, physical examination, laboratory profiles, vital signs, and Electrocardiograms (ECGs), as deemed by the Principal Investigator (PI) or designee.

Exclusion Criteria:-

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
* Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
* Participation in another clinical study within 60 days or within 10 half-lives (if known), prior to the first dosing, whichever is longer, or previous participation in another PORT 77 study or study part.
Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics

Chronic pain is an extremely disabling disease. It is a major public health problem due to the lack of effective therapy.

Chronic postoperative pain (CPOP) is defined by a painful symptomatology in the operated area unrelated to previous pain, present for more than 3 months, and without any link to surgical complication.

The prevalence of chronicization of postoperative pain is 30% after total knee arthroplasty.

Identification of clinical, biological and psychological profiles are crucial to prevent CPOP.

A biologic factor, Brain Derived Neurotrophic Factor (BDNF) produced by a variety of cells is a key regulator of neuroplasticity. BDNF is increasingly studied in the mechanisms of cerebral sensitization and pain chronicization. The role of BDNF in pain of patients remains to be explored in a prospective study. The aim of this observational study is to compare the kinetics of BDNF after total knee arthroplasty in patients with and without CPOP.

Patients will be included in the study at the preanesthetic consultation. Serum BDNF levels will be measured preoperatively, 48h postoperatively, 3 and 6 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Social security affiliation
* Adult patients
* Signed informed consent
* Score ASA (American Society of Anesthesiology) 1-3
* Total knee arthroplasty

Exclusion Criteria:

* Patient unable to exercise consent
* Pregnant women
* Vulnerable people
* Patients not included in the postoperative rehabilitation program
* Patients unable to complete the pain assessment questionnaires
* Chronic pain patients (other than knee arthrosis)
* Neuropathic pain patients (beforehand)
* Inflammatory diseases, progressive cancer, sepsis, immunosuppression known
The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease

Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Many drugs used for the treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury. Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused by reactive oxygen species in different experimental ulcer models. The aim of this study is to evaluate the role of exogenous melatonin in the treatment of reflux disease in human either alone and in combination with omeprazole therapy.


Eligibility Criteria:
Inclusion Criteria:

* patient with GERD ranged from 42 to 56 years

Exclusion Criteria:

* patients with cardiac disease
* patients with renal affection
* patients with liver diseases (due to drug induced, autoimmune disease and viral hepatitis)
* patients on the drugs known to affect the GIT motility (phenothiazines, anticholinergics, nitrates or calcium channel blockers) were excluded during the time of conduction of the study or the preceding two weeks
Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis

The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum TWEAK level in psoriatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe plaque psoriasis of any age and gender.

Exclusion Criteria:

* History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
* Pregnancy and lactation.
* Infections
* Patients with chronic diseases: hepatic disorders, hematologic disease, chronic renal failure or cancer