cyrilzakka/clinical-trials huggingface dataset:
Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80% of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the development of glucose intolerance and T2DM. The project is targeting the gap in providing effective treatment of metabolic impairments associated with OSA, particularly T2DM. In contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure) on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP treatment, as investigators suggested recently. Clearly, the search for additional treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM development. The aim of the study is to target adipose tissue and muscle dysfunction leading to elevated FFA and develop thus novel pharmacological treatments based on lipolysis inhibition and stimulation of FFA oxidation.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes mellitus
* Age 18 - 85 years
* BMI 22-40 kg/m2
* moderate or severe OSA diagnosed by home sleep study

Exclusion Criteria:

* treatment with insulin
* other acute or chronic endocrine or inflammatory disease
Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain

According to recent studies, patients following craniotomy suffer more than minimal pain; two-thirds of patients experienced moderate to severe pain. Postoperative pain most often occurs within 48 hours after surgery. Local infiltration of anesthesia is the most simple and effective analgesia. However, the analgesic effect only lasts for a short-time after surgery, and it cannot adequately meet the needs of postoperative analgesia after craniotomy. Several studies have shown that the mixture of dexamethasone with local anesthetics could reduce the postoperative pain scores better than local anesthetics alone. Lipid microsphere is a relatively new drug delivery system. It is an artificial lipid emulsion. Studies have shown that dexamethasone lipid microsphere, the dexamethasone palmitate emulsion (D-PAL emulsion), has stronger anti-inflammatory effect than dexamethasone. Therefore, the investigators hypothesize that the pre-emptive scalp infiltration with dexamethasone lipid microsphere plus ropivacaine could achieve superior postoperative pain-relief compared to ropivacaine alone for patients undergoing craniotomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective craniotomy under general anesthesia;
* Age 18-64 years;
* American Society of Anesthesiologists (ASA) physical status of I or II;
* Anticipated tracheal extubation, full recovery and cooperation within 2 hours postoperatively
* Patients required to fix their head in a head clamp during the operation.

Exclusion Criteria:

* Previous history of craniotomy;
* Plan to delay extubation or no plan to extubate;
* Patients who cannot use the patient-controlled analgesia (PCA) device;
* Patients who cannot comprehend the instructions of a numeric rating scale (NRS) before craniotomy;
* Body mass index (BMI) \<15 or \>35;
* Allergy to dexamethasone, lipid microsphere, opioids or ropivacaine;
* History of drug abuse or excessive alcohol, chronic opioids use (more than 2 weeks), or use of any sedative or analgesic before surgery;
* History of uncontrolled epilepsy, psychiatric disorders or chronic headache;
* Pregnant or at breastfeeding;
* Symptomatic cardiopulmonary, liver or renal dysfunction or combined with diabetes or other systemic dysfunction;
* Glasgow Coma Scale \<15 before the surgery;
* Intracranial hypertension;
* Peri-incisional infection;
* Patients who have received chemoradiotherapy before the surgery or expected to receive postoperative chemoradiotherapy according to the preoperative imaging.
Extension Study Evaluating Long Term Safety and Activity of AGT-181 in Children With MPS I

AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously.

This is a long term safety and tolerability study of AGT-181 in patients with MPS I who completed the previous 26-week study, AGT-181-101. Information on the biological activity of the investigational drug will also be collected.

AGT-181-101E is a safety and tolerability study of AGT-181 in patients with MPS I who completed the previous 26-week study, AGT-181-101. Information on the biological activity of the investigational drug will be collected as well as longitudinal safety information.

Eligibility Criteria:
Inclusion Criteria:

* 2 years of age or older (and less than 18)
* Must have been previously enrolled in study AGT-181-101
* Written consent and assent as required
* Female patients must not be pregnant, willing to utilize appropriate birth control methods and undergo pregnancy testing during the study

Exclusion Criteria:

* Refusal to complete all assessments
* Pregnant or Lactating
* Received investigational drug within 1 year prior to study enrollment
* Medical condition or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance
* Clinically significant spinal cord compression or evidence of cervical instability (i.e. expected to require intervention during study participation)
* Has developed clinically relevant hypersensitivity/anaphylactoid reactions to AGT-181
Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4 weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during therapy and for four weeks following therapy.

This is a multi-center, randomized, investigator and subject blinded, placebo-controlled eight week study, including a four week treatment period and a four week follow-up period. Three cohorts of HCV positive subjects will be studied in a sequential manner.

Eligibility Criteria:
The following criteria is a brief summary of Criterion required for trial participation.

Inclusion Criteria

* Has chronic hepatitis C virus infection and has previously received at least three months of treatment with any approved therapy and failed to respond, relapsed or did not tolerate therapy
* Has positive HCV RNA by RT-PCR
* Has abnormal ALT levels (at least 2 X ULN)
* Has liver biopsy within past 2 years consistent with chronic hepatitis, no evidence of non-alcoholic steatohepatitis or cirrhosis, and at least mild inflammation
* Has normal liver function indicated by: PT =\< 2 sec. prolonged compared to the ULN, Albumin \>= 3.5 g/dL, Total bilirubin =\< 1.5 mg/dL
* ANA titer =\< 1:160

Exclusion Criteria

* Has positive skin test for tuberculosis
* Has ALT value \>= 300 IU/L
* Has abnormal hematological parameters indicated by: ANC \< 1500/mm3 and Platelets \< 100,000/mm3
* Has creatinine \> 1.5 X ULN
* AFP \> 50 ng/mL and evidence of hepatocellular carcinoma on ultrasound
* Is a carrier of the hepatitis B surface antigen (HBsAg), positive for HIV-1 and/or HIV-2 antibodies
Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma

The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.

The study will open with Schedule 1 (S1, intermittent) with initiation of Schedule 2 (S2, weekly) and Schedule 3 (S3, continuous), which may occur in parallel after observation of clinically significant related dose limiting toxicity (DLT) in the S1 schedule. Dosing will be initiated on Day 1 with intermittent weekly dosing continuing for 21 days (1 Treatment Period). Expansion of Dose Escalation Cohorts may occur for S1 and S2 at the recommended phase 2 dose level(s) and a Biomarker Expansion Cohort may be opened in S1 and/or S2.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented malignancy (solid tumor or lymphoma)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
* Predicted life expectancy of at least 3 months
* Adequate hematopoietic and hepatic function, and normal renal function
* Fasting glucose \<7mmol/L at baseline
* Left ventricular ejection fracture (LVEF) by Multiple gated acquisition scan (MUGA)≥ 60%
* Practice effective contraceptive measures throughout study
* Verbal and written informed consent
* Prior therapy:

  * Chemotherapy, minimum of 3 weeks and recovered from any treatment-related toxicities (except for alopecia, and grade 1 neurotoxicity) prior to registration
  * Hormonal, discontinued prior to registration
  * Radiation, minimum of 21 days and recovered from toxic effects prior to registration
  * Surgery, provided wound healing has occurred

Exclusion Criteria:

* History of significant cardiac disease unless well controlled
* Discontinuation from prior therapy due to cardiac toxicity
* Active or uncontrolled infections
* Serious illness or medical condition that could interfere with study participation
* History of any psychiatric condition that might impair understanding or compliance
* Documented history of diabetes mellitus
* Pregnant or breastfeeding females
* Unstable symptomatic brain metastases, that require steroid or that have required radiation in the last 28 days
* Chronic systemic steroid use for cancer related condition
* History of allergic reactions
* Patients with cataract who are expected to undergo surgery within 6 months of registration
* Use of drugs causing QT interval prolongation within 14 days prior to dosing
* Patients with clinically significant electrolyte imbalances
Development of an Assessment Tool for Health-related Quality of Life in Children and Adolescents With Pompe Disease

Health related quality of life (HrQoL), is "the patient's subjective perception of the impact of his disease and its treatment on his daily life, physical, psychological and social functioning and well-being" and thus constitutes a patient reported outcome (PRO) of utmost importance. Generic HrQoL instruments can by definition not capture disease-specific parameters nor are they sensitive enough to detect their changes. In this study, a disease-specific HrQoL questionnaire for children and adolescents will be developed. Patients and parents will be involved in focus groups and interviews to identify relevant contents. The instrument will be tested for validity and reliability.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PD from age 8 years

  * Parent of patient(s) \< 18 years with PD
  * Able to give informed consent as documented by signature
  * Sufficient command of the German language

Exclusion Criteria:

* - Inability to follow the procedures of the study, e.g. due to language problems or severely reduced health status
A Prospective Study of Electronic Symptom Reporting Via Mobile Phone Among Patients With Advanced Non-Small Cell Lung Cancer

Symptoms are common among patients with advanced malignancy undergoing treatment, and yet often go unrecognized by treatment providers. In addition to contributing to morbidity, poorly controlled symptoms drive emergency room utilization and hospital admission in this population, representing significant cost to patients, families, and the health care system. Systematic collection of patient-reported outcomes (PROs) has been proposed as a way to arm providers with the information necessary to intervene early, intensify symptom management, and improve symptom control. Recent research suggests that a standardized, web-based program of weekly patient-reported symptom monitoring leads to improved health-related quality of life and reduced acute care utilization; it may also prolong overall survival. Despite mounting evidence supporting its use among oncology patients, systematic PRO collection is lacking at most cancer centers, and optimal models for collection of PROs are poorly understood. The objective of this study is to evaluate prospectively the feasibility of a novel mobile phone-based intervention of weekly symptom reporting, among patients undergoing treatment for advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥ 18 years) with advanced (metastatic) non-small cell lung cancer, initiating a new line of palliative-intent treatment at Abramson Cancer Center
* Ability to read and respond to questions in English
* Ability to provide informed consent to participate in the study
* Access to a smart phone capable of SMS-text messaging and internet access

Exclusion Criteria:

* Inability to read and respond to questions in English
* Inability or unwillingness to provide informed consent to participate in the study
* Inability to engage with SMS-text based platform
* Current enrollment in a clinical trial
Exercise and Cognitive Rehab in Older Cancer Survivors

The objective of the study is to evaluate the feasibility of a combined mobile health exercise and cognitive rehabilitation intervention and its effect on cognition in a single-arm pilot study that recruits cancer survivors.

Cancer survivors (i.e., those who completed cancer-directed treatment) often experience long-term treatment-related effects, such as cancer-related cognitive decline (CRCD). Exercise and cognitive rehabilitation (rehab) interventions have been shown to improve CRCD symptoms in both cancer and non-cancer populations. Among older adults without cancer, studies have also demonstrated that multicomponent interventions combining exercise and cognitive rehab are more effective in improving cognitive dysfunction than either intervention alone. However, exercise adherence and self-efficacy are lower in older adults compared to younger adults, and combined interventions may be too demanding for older cancer survivors. Therefore, innovative ways are needed to integrate an exercise program within the context of a cognitive rehab program to increase exercise adherence and self-efficacy, and ultimately improve CRCD symptoms through a streamlined multicomponent intervention.

In this study, the investigators propose to refine a multicomponent Exercise and COgnitive rehab intervention (E-Co) and assess its feasibility in older cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years at the time of consent
* Have a diagnosis of any cancer
* Have completed curative intent treatments

  * Patients on endocrine therapies are allowed to enroll
  * Patients with hematologic malignancies after autologous or allogeneic stem cell transplant are allowed to enroll as long as they have completed curative-intent treatment
* Have concerns about memory or other thinking abilities following cancer treatment\*
* English speaking (because the interventions are available in English language only)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
* No medical contraindications for exercise per oncologist#
* Able to walk 4 meters#
* Able to provide informed consent#

(\*) Confirmed by asking the patient (#) Confirmed through eligibility confirmation with the patient's oncologist or their designee

Exclusion Criteria:

* Physical, psychological, or social impairments that would interfere with patient's ability to participate in the study or participate in the intervention, as determined by the PIs and oncology team.
HCV, HBV, HIV Testing During Consultation With Anesthesiologist

The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).

The aim of the study is to assess the feasibility of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France.

The national guidelines recommend at least one HIV testing during life and, more recently, one HCV testing during life to eradicate HCV infection. HBV testing is recommended in patients coming from high prevalence countries, IVDU, prisoners, patients with multiple sexual partners.

The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).

HIV testing will use finger-stick whole blood (FSB) INSTI® HIV-1 \& HIV-2 Rapid Antibody Test FSB (BioLytical TM Laboratories Inc., Richmond, B.C., Canada), with a sensitivity 99% \[96.3-99.7\] and a specificity 99.3%.

HCV testing will use finger-stick whole blood (FSB) Oraquick® HCV test, with a sensitivity and a specificity 99.1 and 100% respectively.

HBV testing will use finger-stick whole blood (FSB) Vikia® HBs Ag test, bioMérieux with a sensitivity and a specificity 96.5 and 99.9% respectively.

Eligibility Criteria:
Inclusion Criteria:

* patient ≥ 18 years-old
* planned surgery in Lariboisiere Hospital, Paris, France
* able to give written informed consent for testing
* proposed to be tested for HIV and HCV if no previous testing found in the medical record
* proposed to be tested for HBV if the patient belong to a high-risk group: high prevalence area (Asia, sub-Saharan Africa, French Indies, East and South Europe, North-Africa, Middle-East, India, Pakistan, South-America), IVDU, prisoners, unprotected sexual intercourses.

Exclusion Criteria:

* patient \< 18 years-old
* emergency surgery
* unable to give written informed consent for testing: psychiatric diseases, neurologic diseases, ...
* a previous testing for HIV and HCV found in the medical record and no obvious risk factor after previous testing
* the patient does not belong to a high-risk group for HBV
Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix

The present randomized clinical trial is aimed at evaluating the efficacy of recombinant human platelet-derived growth factor in combination with collagen matrix for the treatment of multiple adjacent gingival recessions

Despite the fact that gingival recession is most often a generalized condition rather than being localized to a single tooth, most of the data currently found in the literature pertains to the treatment of localized gingival recessions.

The gold standard treatment for this condition involves the use of an autogenous connective tissue graft, that is associated with increased patient morbidity.

Biomaterials have progressively gained popularity due to their advantages when compared to autogenous grafts, such as unrestricted availability, avoidance of a secondary surgical site, reduction of the surgical time, and the patient's preference.

Collagen matrix is one of the most used soft tissue substitute for the treatment of gingival recessions. Combining this scaffold material with a growth factor could enhance its outcomes. In particular, root coverage using platelet-derived growth factor can also promote regeneration of new cementum, periodontal ligament and bone.

Therefore, the aim of the present study is to investigate the effect of platelet-derived growth factor in combination with collagen matrix outcomes for the treatment of multiple adjacent gingival recessions.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Periodontally and systemically healthy
* Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
* At least two multiple adjacent gingival recessions (with at least one 2 mm or deeper) requiring surgical intervention for root coverage
* No interproximal attachment/bone loss
* No prior experience of root coverage procedures within the last 1 year
* The patient must be able to perform good oral hygiene

Exclusion Criteria:

* Contraindications for periodontal surgery
* Patients pregnant or attempting to get pregnant (self-reported)
* Untreated periodontitis
* Persistence of uncorrected gingival trauma from traumatic toothbrushing
* Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated
* Presence of severe tooth malposition, rotation or clinically significant super-eruption
* Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking
* Allergy to collagen-based medical products
Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

Researchers are trying to find out if the Resilient Living Program will improve quality of life, stress, anxiety, sleep, fatigue, and resilience in patients with advanced cancer and their caregivers.


Eligibility Criteria:
Inclusion Criteria for patients:

* Age ≥18 years
* English fluency
* No diagnosed severe cognitive impairment
* Diagnosis of stage IV solid tumor cancer
* Expected prognosis \>6 \<18 months
* Provide written informed consent
* Ability to complete questionnaire(s) by themselves or with assistance
* Patient baseline distress score ≥4/10 OR identified as having distress that would benefit from program by care team or provider
* Ability to do first Resilient Living session in person

Inclusion Criteria for caregivers:

* Self-identifies as a caregiver of a patient that meets the above cancer diagnosis criteria, and who also participates in the study
* Provide written informed consent
* Ability to complete questionnaire(s) by themselves or with assistance
* Age ≥18 years
* English fluency
* No diagnosed severe cognitive impairment
* Ability to do first Resilient Living session in person

Exclusion Criteria:

* As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded.
* Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
Short-Term and Long-Term Effects of Ankle Joint Taping and Bandaging on Balance, Proprioception and Vertical Jump Among Volleyball Players With Chronic Ankle Instability

Objective: This study aimed to 1) investigate the long-term effect of taping and bandaging on proprioception, balance, and vertical jump among volleyball players with ankle instability, 2) Compare the short-term effects of taping and bandaging on these outcome measures, 3) Compare the long-term effects of taping and bandaging on these outcome measures.

Design: A single-blinded randomized controlled study Setting: Rehabilitation Laboratory at Istanbul Gelisim University, Turkey Subjects: One-hundred participants with a chronic ankle sprain (CAI) Primary outcome measures: Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester) Interventions: Participants were distributed into three groups: taping group (n=33) received ankle rigid taping, bandaging group (n=33) received ankle bandaging, and control group (n=34) received placebo taping. All three previous external supports were applied for 8 weeks. The measurements were performed at baseline, immediately after applying for support, two weeks after support and eight months after support.


Eligibility Criteria:
Inclusion Criteria:

* Volleyball Player
* 18-30 years old
* Athletes with chronic ankle instability

Exclusion Criteria:

* Previous hip/pelvis knee, or foot surgery within the past year
* Leg length discrepancies
* Known balance impairment due to neurological disorder
* Vestibular disorder
* Pregnancy
* Brain concussion within the previous three months
* Taking any medication that may affect alertness or balance