cyrilzakka/clinical-trials huggingface dataset:
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients.

Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum).

The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy of pantoprazole.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients who completed ALTANA Pharma study BY1023/FK3006 (long-term clinical trial regarding efficacy and tolerability of Pantoprazole in patients not responding to treatment with H2-receptor antagonists or omeprazole)
* Written informed consent

Main Exclusion Criteria:

* Concomitant diseases
* Pregnant or nursing female patients; female patients of childbearing potential who are not using reliable contraception
Deep Versus Superficial Heating in Patients With Knee Osteoarthritis

Heat therapy is frequently prescribed to patients with symptomatic knee osteoarthritis (OA). Deep hyperthermia via localized microwave diathermy is effective in several musculoskeletal painful conditions. However, the efficacy of superficial heating is controversial. Furthermore, no clinical trials have yet directly compared the effects of these treatment modalities in knee OA. Hence, the purpose of the present study is to compare the effects of deep and superficial hyperthermia, induced via microwave diathermy and hot packs, respectively, on pain and function in patients with symptomatic knee OA.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years or older
* Moderate, mono or bilateral knee osteoarthritis
* Pain lasting for at least three weeks

Exclusion Criteria:

* Inability or unwillingness to sign informed consent
* Previous surgery on the affected knee
* Intra-articular injections with steroids or hyaluronic acid in prior 6 months
* Physical therapy for knee problems in prior 6 months
* Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee
* Chronic NSAID or steroid treatment
* Cognitive or psychiatric disorders
* Pregnancy or breastfeeding
* Contraindications to hyperthermia (cancer in prior 2 years or active cancer treatment, local thrombosis, impaired arterial circulation, altered cutaneous thermal sensitivity, local infections or systemic acute infections, metal implants or prosthesis, severe osteoporosis
Immune and Genomic Markers in ALK+ NSCLC

The purpose of this research study is to obtain and study clinical history, and tissue and saliva specimens if available from participants with Anaplastic Lymphoma Kinase-ALK+ Non-Small Lung Cancer(NSCLC)

The purpose of this study is to establish a registry of clinical data and tumor specimens of patients with advanced ALK+ non-small lung cancer (NSCLC) (defined as NSCLC harboring an ALK gene rearrangement). This will allow in-depth, comprehensive genomic and immunophenotypic analyses of ALK+ tumors. Together with the clinical data, these biologic specimens will enable the conduct of basic and translational research to identify genomic and immunologic markers associated with clinical outcomes for ALK+ patients.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1 - Alive Individuals

* Men or women 18 years of age or the age of majority for their residential state of the United States, or older, at the time of consent.
* Histologically or cytologically confirmed advanced stage IIIB-IIIC not amenable to curative approach multi-modality (e.g., chemoradiation and/or surgery) treatment, or stage IV non-small cell lung cancer (NSCLC)
* Demonstration of having advanced ALK+ NSCLC, as assessed by fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), next-generation sequencing (NGS) or circulating tumor DNA analysis (ctDNA). For ALK FISH, fusions must have been detected in at least 15% of tumor cells.
* Willingness to provide clinical and medical information to the study team as required.
* Willingness to provide archival tumor tissue, if available. Patients may enroll even if no tumor tissue is available.
* Ability to read, write and communicate in English.
* Ability to sign a web-based informed consent form.

Cohort 2 - Deceased Individuals

* Deceased individuals diagnosed with advanced ALK+ lung cancer at age 18 years or older may be studied on a case by case basis. Inclusion will require availability of adequate archived tissue and release of tissue and records by next of kin, if available.

Exclusion Criteria:

* Participants who are unwilling to provide informed consent.
* Participants who are younger than 18 years of age.
* Participants who are unable to comply with the study procedures.
* Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
* Participants who have previously enrolled to the study.
Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant

Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:

* Internal fixation;
* Interphalangeal Compression;
* Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this specific arthrodesis. The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.

The safety of the Ipp-On will be described in terms of rate of device related complications.

The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
* Age \>= 18 years
* Have willingness to give his/her Data Transfer Authorization

Exclusion Criteria:

* Contraindication of the implantation of the Ipp-On The implant should not be used in a patient who has currently, or who has a history of: • Active local or systemic infection

  * Severe peripheral vascular disease
  * Severe longitudinal deformity
  * Insufficient quantity or quality of bone to permit stabilization of the arthrodesis
  * Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process
  * Suspected or documented metal allergy or intolerance.
* History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term

The purpose of this study (RECOVER-LT) is to better understand the long-term paths of recovery from opioid use disorder (OUD) for an additional 5 year period after the original RECOVER (NCT03604861) study. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social and economic well being will be monitored in order to identify factors associated with recovery from OUD.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who enrolled in the RECOVER study
* Ability to comply with current study protocol requirements for data collection
* Provide informed consent

Exclusion Criteria:

* Minors will not be included
* Prisoners will not be included. If participants become incarcerated during this study, they will not be contacted to complete assessments during their incarceration. If the incarceration ends during the study, they may be contacted to participate in assessments
* Adults who are not capable of consenting on their own behalf
A Post Market Evaluation After Treatment of Nasolabial Folds

This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate the safety of repeat treatment of the nasolabial folds 12 months after the initial treatment.


Eligibility Criteria:
Inclusion Criteria

* 18 years or older
* Intent to undergo correction of both nasolabial folds
* WRSR 3-4
* Signed informed consent

Exclusion Criteria:

* Markedly indurate defects such as significant mid-face volume loss or prominent commissures.
* Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or in the area to be treated.
* Subjects with known hypersensitivity to any ingredient of the study product or anaesthesia used in the study.
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steriodal anti-inflammatory drugs, acetylsalicylic acid, Omega 3 and Vitamin E) within 2 weeks prior to treatment, or a history of bleeding disorders.
* Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids. (Inhaled corticoids are allowed).
* Cancerous or pre-cancerous lesions in the treatment area.
* Subjects who have performed aesthetic facial surgery.
* Tissue augmenting therapy with non-permanent filler or neurotoxin below the lower orbital rim in the last 12 months.
* Facial laser treatment or chemical peeling below the lower orbital rim during the last 6 months.
* Permanent implant or filler, including fat-injections, placed in the area to be treated.
* Women who are pregnant or breast feeding or who are planning to become pregnant during the study period.
* Participation in any other clinical study within 30 days prior to inclusion.
* Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment, psychiatric disorders or subjects not likely to comply to study procedures or to avoid other facial cosmetic treatments below the lower orbital rim).
* Subjects who are study site staff for this study, or close relatives (defined as parents, siblings, children or spouse) of the study site staff, as well as subjects who are employed by the sponsor company, or close relatives of employees at the sponsor company.
Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients

The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors.

Patients with locally advanced gastric cancer (T3-4 and/or N+) are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound.

The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy. Chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20.

Estimate whether R0 resection rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach
* Age ≥18 years old
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Body mass index ≥ 18
* No prior chemotherapy or chemoradiotherapy
* TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
* No evidence of metastasis (M0)
* Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)

Exclusion Criteria:

* Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
* Patients with evidence of severe or uncontrolled systemic disease
* Medically unfit for chemotherapy
* Tumors involving the esophageal junction, comprising siewert I to III
IVUS Guidance to Reduce Contrast in Coronary Angioplasty

This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.

Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous coronary interventions. Despite various efforts, very few preventive measures have been shown effective in reducing its incidence. The final volume of contrast media utilized during the procedure is a well-known independent factor affecting the occurrence of CI-AKI.

Intravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool during percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise information for guiding the PCI strategy. IVUS allows accurate vessel and lesion sizing, determination of plaque calcification (and the need for pre-stent plaque preparation), assessment of post-stent results (including edge dissections and residual lesion, as well as stent underexpansion or incomplete apposition). Therefore, IVUS has the potential to reduce the utilization of contrast media during PCI.

In the present study, we hypothesize that IVUS guidance is associated with a significant reduction in the volume of contrast media during PCI, in comparison to standard angiography-guided intervention.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \>=18 years
* Coronary artery disease scheduled for percutaneous intervention
* Technical feasibility for intravascular ultrasound to guide coronary angioplasty
* Increased risk for contrast-induced acute renal failure (e.g. age \> 80 years, female gender, diabetes, urgent or emergent procedure priority, diabetes, congestive heart failure, increased baseline serum creatinine, decreased calculated or measured creatinine clearance, intra-aortic balloon pumping, previous renal transplantation or single kidney)

Exclusion Criteria:

* Anticipated technical impossibility for intravascular ultrasound
* Unknown baseline renal function
* Baseline end-stage renal failure needing dialysis
* Acute renal failure with dynamic change in renal function at the time of index procedure
* Iodine contrast administration \<= 72 prior to index procedure
* Known allergy to iodine contrast
The Role of Arnica on Muscle Pain Following Eccentric Exercise

Arnica in a topical gel formulation will be compared to a placebo to determine whether it decreases muscle soreness following leg exercise when applied to the legs.

Design: The design is a randomized, placebo-controlled, double-blind trial. Each participant will receive 2 containers of gel. One container will be marked "LEFT" and one "RIGHT." One container will contain a commercially available arnica gel formulation, and the other will contain a placebo gel, identical in appearance to the arnica. Subjects will not know which container contains which product. Each participant will also be given a form containing an analog pain scale for each leg. The participant will rate his or her pain in each leg separately on the day before exercise. Each subject will then be asked to perform calf raises using the following protocol:

* The participant removes shoes.
* Active range of motion of the ankle is measured bilaterally using a goniometer.
* He or she places the metatarsal portion of his or her foot on a step that is 7 inches above the floor. Handrails are provided for safety and comfort
* He or she then performs heel lifts by rising up on the stair using the foot on the stair, holds this for 2 seconds, then maximally dorsiflexes the foot for a count of 2 seconds. A metronome set to generate a tone every 2 seconds guides the pace of this.
* This is repeated 25 times, or until the subject is unable to complete a full cycle.
* He or she then performs the same sequence using the other leg.
* A second set of 20 repetitions is performed in each leg, followed by a final 15 repetitions.
* The gel is applied immediately after exercise to both lower legs. Subjects are instructed not to wash off the leg for at least one hour after application.
* The pain score is completed for each leg 24 hours later, and the gel is applied to each leg. Again, subjects are instructed to leave the gel undisturbed for at least one hour.
* Approximately 48 hours later the subject returns for measurement of ankle range of motion, again completes a pain score and applies the gel for a final time. Subjects are instructed to leave the gel on the legs for at least one hour.
* To measure muscle tenderness, a 1cm sphere is placed on the subject's mid-calf, and compressed by a standardized 5 pound weight. The subject provides a tenderness score for each leg using the same pain score.
* A final pain score is completed by each subject at approximately 72 hours.

Neither subjects nor the researchers doing the data collection or analysis will know which gel is associated with which formulation (placebo vs. Arnica). Controls are within-subjects.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* two fully functional legs

Exclusion Criteria:

* allergy or sensitivity to the ester family
* open wound or inflammatory condition on legs
* chronic or acute leg pain
* neuropathy involving one or both legs
Neuroendocrine Mapping of the Cerebral Cortex

This study is investigating brain regions that share functional connectivity with the hypothalamus and the stimulation of those regions using repetitive transcranial magnetic stimulation (rTMS) to activate the hypothalamus indirectly. The goal of this study is to determine the effectiveness of rTMS in influencing the hypothalamus to better understand the mechanisms between it and the neuroendocrine processes it controls.


Eligibility Criteria:
Inclusion Criteria:

* Age: 21-55
* Gender: Females and Males
* Weight: Less than 280 pounds
* Mobile
* Normal vision with corrective lenses if necessary
* Fluent in English (written and spoken)

Exclusion Criteria:

* History of epilepsy/seizures (including history of withdrawal/provoked seizures)
* Metal implant in brains (e.g. deep stimulation), cardiac pacemaker, or cochlear implants
* Shrapnel or any ferromagnetic item in the head
* Showing symptoms of withdrawal from alcohol or benzodiazepines
* Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
* Migraine or significant headaches
* Shoulder or neck stiffness
* Over 280 pounds
* In-dwelling ferrous metals
* Left handed
* Abnormal hearing
* Abnormal vision that cannot be corrected with lenses
* Claustrophobia
* Illicit drug use
* Psychotropic medication use
* Marijuana and/or nicotine use
* Psychiatric or neurological conditions
* Endocrine conditions
* History of head trauma with loss of consciousness
Salivary Therapeutic Drug Monitoring of Anti-Tuberculosis Drugs

In tuberculosis patients, salivary concentrations will be compared to plasma/serum concentrations of several anti-tuberculosis drugs. If salivary concentrations correctly represent blood concentrations, this non-invasive sampling of saliva could be used for TDM of the tested drugs.

TDM (Therapeutic Drug Monitoring) with blood samples is already part of the treatment of some tuberculosis (TB) patients to reduce development of drug resistance and toxic drug concentrations. Performing TDM with saliva instead of plasma or serum could reduce the burden of blood sampling. This study examines if this non-invasive sampling of saliva could be used for TDM of several anti-TB drugs.

The study is an observational cohort study with adult tuberculosis patients as subjects. The drugs that are studied are isoniazid, rifampicin, ethambutol, pyrazinamide, moxifloxacin, amikacin, kanamycin, capreomycin, ethionamide, prothionamide, cycloserine, terizidone, linezolid, clofazimine, bedaquiline, delamanid, p-aminosalicylic acid (PAS), imipenem-cilastatin, meropenem, ertapenem, amoxicillin-clavulanate and thioacetazone.

Saliva samples will be taken simultaneously with blood samples for standard TDM. Serum/plasma and saliva drug concentrations will be determined with a validated LC-MS/MS (liquid chromatography-tandem mass spectrometry) method. The correlation and linearity between saliva and plasma/serum concentrations will be tested. The saliva-plasma or serum ratio based on area under the time-concentration curve (AUC) is calculated for the investigated anti-TB drugs. Also pharmacokinetic parameters in serum/plasma and saliva will be calculated and compared to provide a complete image of pharmacokinetics of the anti-TB drugs in saliva.

Eligibility Criteria:
Inclusion Criteria:

* Tuberculosis is confirmed by culture or molecular test
* Patient is treated with anti-tuberculosis drugs included in study
* Patient receives Therapeutic Drug Monitoring (TDM) in routine care
* Patient signed informed consent

Exclusion Criteria:

* Patient with severe problems in the oral cavity, making saliva sampling painful