cyrilzakka/clinical-trials huggingface dataset:
Northern Survey on Therapeutic Oxygen Prescription

This is a prospective multicenter observational trial. Included patients and attending physician complete a standardized questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic lung disease, age \> 18 years
* Established domiciliary LTOT \> 4 weeks
* Scheduled for control of oxygen therapy with arterial/capillary

Exclusion Criteria:

* No informed consent
* Pulmonary exacerbation within the last 2 weeks
* Signs of heart failure (edema, congestion)
Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects

This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of DHA-NAT (C22:6 N-acyl taurine, an endogenous metabolite derived from the omega-3 fatty acid, docosahexaenoic acid) on postprandial plasma triglyceride levels following a high-fat meal.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy
* Age between 18 and 30 years
* Body mass index between 18.5-25 kg/m2
* Informed consent
* Moderate level of physical activity assessed with IPAQ (short version)

Exclusion Criteria:

* Use of fish-oil/omega-3 FA supplements within the last 3 months
* Regular tobacco smoking or use of other nicotine-containing products
* Allergy or intolerance to ingredients included in the standardised meals
* Weekly intake of fish \>350 g (23)
* First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) \>48 mmol/mol, familial hypercholesterolemia/hyperlipidemia
* Anaemia (haemoglobin below 8.3 mmol/L)
* Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \>2 times upper normal values (Normal values: ALAT \< 70 U/L, ASAT \<45 U/L)
* Nephropathy (serum creatinine \>105 μmol/L) and/or albuminuria (\>30 mg/g albumin in urine))
* History of hepatobiliary or gastrointestinal disorder(s)
* Any physical or psychological condition, or ongoing medication, that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache

Postcraniotomy headache (PCH) has been underestimated for the past decades. However, current treatments for PCH are either considered insufficient or accompanied by severe side-effects. Some studies revealed that peri-incisional injection of a mixed cocktail that contains ropivacaine, epinephrine, ketorolac, and methylprednisolone showed significant efficacy in relieving postoperative pain after total hip or knee arthroplasty. Previous literature reported that the cause of PCH was related to incision of the scalp and dura, which is considered similar to causes to postoperative pain after total hip or knee arthroplasty. Thus, investigators suppose that the cocktail mixture can better relieve PCH in adults.


Eligibility Criteria:
Inclusion Criteria:

1. Having signed the informed consent,
2. age 18-80 yrs,
3. American Society of Anaesthesiologists (ASA) physical status of I or II,
4. scheduled elective supratentorial craniotomy,
5. planned head fixation in a skull clamp.

Exclusion Criteria:

1. Allergy to LAs,
2. alcohol abuse,
3. intracranial hypertension,
4. active psychiatric disorders,
5. uncontrolled epilepsy,
6. chronic opioid use (more than 2 weeks),
7. undergoing a revision craniotomy,
8. high probability of having postoperative radio- or chemotherapy,
9. expectation of delayed extubation or no planned extubation,
10. pregnancy or breastfeeding during the study,
11. extreme body mass index (BMI) (less than 15 or more than 40),
12. preoperative Glasgow Coma Scale less than 15,
13. undergoing emergency or awake craniotomy surgery,
14. inability to understand the use of the NRS or the PCA. (Patients are informed of the instructions of NRS (from 0 to 10, where 0 and 10 represent no pain and the worst imaginable pain, respectively) and PCA after signing the informed consent the day before the operation. Patients who cannot understand the instruction of NRS and PCA will be excluded from the study.)
Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery

The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro).

Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 75 years of age
* Bone quality class III or IV, (according to Lekholm \& Zarb16)
* Willing to give signed informed consent

Exclusion Criteria:

* Need for bone augmentation of the maxilla
* Tobacco smoking more than 5 cigarettes/day
* Any systemic disease or condition that would compromise post-operative healing and/or osseointegration
* Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Unable or unwilling to return for follow-up visits
* Bruxism or other parafunctional activity
Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis

) Finding a unique pattern in the triglyceride composition of patients with hypertriglyceridemia that increases the chances of getting pancreatitis and which can serve as a laboratory predictive tool for patients and define them as a at-risk population.

2) Finding the typical fatty acid composition in triglycerides for patients at high risk of pancreatic acute inflammation that can be used to develop unique drugs for pancreatic acute inflammation caused by high levels of triglycerides.

The study will be conducted at the Sheba Medical Center Lipid Institute, number of participants: 10 healthy participants, 10 participants with hypertriglyceridemia without prior pancreatitis and 10 participants with hypertriglyceridemia and at least one case of severe pancreatitis in the last 5 years.

A total of 30 participants Participants who are found suitable during their visit to the Lipid Institute Clinic or during their hospitalization at Sheba Medical Center will receive an explanation of the study, will be asked to sign a consent form. And check the fatty acid levels. Healthy volunteers who meet the inclusion conditions will also be asked to sign a consent form and their blood will be taken and kept frozen for further study

Eligibility Criteria:
Inclusion Criteria:

* 1) Healthy participants - triglyceride levels\< 150 mg / dl over the past 5 years, with no diabetes or cardiovascular disease in the background.

  2) Participants with triglyceride levels 1000-5000 mg / dl without acute pancreatitis cases in the past.

  3) Participants with triglyceride levels 1000-5000 mg / dL and at least one case of acute pancreatitis in the last 5 years.

Exclusion Criteria:

1. A past pancreatitis event that occurred with measurement of triglyceride levels greater than 5000 mg / dL.
2. Acute pancreatitis events in the past that occurred for a cause other than hypertriglyceridemia -
Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma

The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.

The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.

Eligibility Criteria:
Inclusion Criteria:

* Hodgkin's lymphoma
* Second or higher relapse (first relapse if high-dose chemotherapy not possible)
* Age \>/= 18 years
* No major organ dysfunction or intercurrent disorder
* Written informed consent

Exclusion Criteria:

* Pregnant or nursing
Resurfacing Hemiarthoplasty Versus Conventional Stemmed Arthroplasty

Hypothesis: What is the difference in disease specific quality of life between patients who receive a humeral surface replacement hemiarthroplasty verusu a conventioanl stemmed hemiarthroplasty

The purpose of this multi-centered, randomized, controlled trial will be to determine if patient self-assessed outcomes (Western Ontario Osteoarthritis of Shoulder Score- WOOS) following humeral resurfacing are superior to those following a conventional, modular, stemmed, humeral prosthesis. The first phase of this study will be a one year pilot recruitment period. This is necessary in order to determine both a center by center, and national recruitment rate, and to determine a sample size necessary for a sufficiently powered full randomized trial. If a full randomized trial is not considered feasible following Phase 1, then a prospective cohort study will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Recent humeral resurfacing
Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)

The primary intervention offered through this study is a manualized and culturally adapted CBT intervention combined with an exercise intervention, administered by trained Community Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood symptoms and at risk of disability. In addition to the intervention implementation, the study examines how to successfully build collaborative research for the provision of evidence-based mental health and disability prevention treatments for ethnic minority elders in community-based settings. Thus, the study will evaluate the three components necessary for a successful intervention: efficacy, since the intervention must work, acceptability among clients and partnering agencies, and feasibility and sustainability within the organization.

The researchers have partnered with 5 community-based organizations and 2 clinics, each of whom will recruit 60 elder participants to be randomized into either the intervention (CBT+exercise) or control (enhanced usual care) groups. Each participant randomized into the intervention group will receive 10 sessions of individual CBT for depression and anxiety (Positive Minds), using a translated and culturally adapted manual, and administered by a trained community health worker. In addition, each participant will engage in three exercise groups per week for 12 weeks, using the Increased Velocity Specific to Task (Strong Bodies; InVEST) protocol. Both intervention and control groups will be assessed biweekly for symptoms of depression, anxiety, and suicidality, and both groups will participate in a thorough assessment at baseline, and 2, 6, and 12 months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* Age 60+
* Fluency in English, Spanish, Mandarin or Cantonese
* Score above threshold on PHQ-9, GAD-7, or Geriatric Depression Scale (GDS-Short Form)
* Score within threshold of SPPB

Exclusion Criteria:

* Participants will be excluded if there is evidence of:
* Current substance use disorders
* Current or last 3 months of specialty mental health treatment
* Evidence that patient the participant lacks capacity to consent assessed using the UCSD Brief Assessment of Capacity to Consent.
* Suicidal risk (score of 4 or 5 on the Paykel suicide questionnaire), whereby participant will be referred for immediate treatment to specialty care
* If the participant's physician advises against strenuous physical exercise.
* Exclusion from the disability component will also happen if the participant is home-bound, has an acute or an exacerbated chronic disease, or has neuro-musculoskeletal impairment that prevents them from participating in the exercises
Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Have voluntarily signed an informed consent form.
* Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s).
* Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
* Subject weights at least 37 pounds (17 kg)
* Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
* Subject can swallow pills and subjects and parents are able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria:

* Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury.
* Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind.
* Subject has a history of, or ongoing, serious medical problem.
* Subject has a history of significant allergic reaction to any drug.
* Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
* Subject requires ongoing treatment with any psychiatric medication.
MINDFUL-PC for Portuguese Speakers Pilot Study 2020

The study evaluates the effects of the Mindfulness Training for Primary Care (MTPC) Portuguese-adapted version on heart rate variability during a demanding cognitive task. The study also evaluates the effects on mental health, quality of life, self-regulation and behavior outcomes. The study will also complete the MTPC cultural adaptation process for Brazilian culture.

This single-arm, pre-post, non-randomized, unblinded, pilot trial evaluates the effects of Mindfulness Training for Primary Care (MTPC) Portuguese-adapted version on heart rate variability during a demanding cognitive task, i.e., Sustained Attention to Response Task (SART). Secondary aims are the following: 1) to measure pre/post outcomes for a) mental health (anxiety, depression, stress); b) quality of life; c) self-regulation (self-compassion, mindfulness, interoceptive awareness, difficulties in emotion regulation); and to determine the rate of d) chronic disease self-management action plan initiation; and 2) to complete the MTPC cultural adaptation for Brazilian culture through a) Satisfaction and Suggestions Survey; and b) Interviews of MTPC Group Leaders about their experience teaching the program Portuguese-adapted version.

Eligibility Criteria:
Inclusion Criteria:

* Current CHA patient with an enrolled CHA primary care doctor.
* CHA patients 18 years of age and older.
* Able to tolerate and participate in interviews and engage in all procedures.
* Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
* Must be able to fill out the study questionnaires on a computer or compatible mobile device.
* Must be willing to attend the two computer task sessions.
* Able to give written consent in Portuguese

Exclusion Criteria:

* Any cognitive impairment that precludes informed consent.
* Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others.
* Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment.
* Behaviors that may cause disruption to a mindfulness group.
* Patients with symptoms of psychosis, thought disorder, and/or severe mental illness, including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of major depressive disorder.
* Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from participation in groups.
* Patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities.
* Patients with highly unstable medical problems that put them at a high risk of hospitalization.
Orchestra Pregnancy Observational Study in Poland

The aim of this project is to document the use of insulin pump therapy (CSII), including sensor augmented pump therapy (SAP), before, during and after pregnancy in women with type 1 Diabetes Mellitus benefiting from the Orchestra donation of Paradigm REAL-Time and Paradigm Veo pumps in Poland.

The project is designed as a multi-center prospective observational Post-Market-Release study to be conducted in up to 30 centers in Poland.

Total duration of the study per patient will be up to 22 months (up to 12 months pre-conception phase, pregnancy, and 6 weeks after delivery). The optimal study start is the beginning of pre-conception phase, however, pregnant women up to the 16th week of pregnancy can participate in the study too. The study end is 6 weeks after delivery. If conception does not occur within 12-months, the patient's study participation is terminated, and the insulin pump might be taken away from the patient. The following therapy is decided by the investigator. If the pump is not taken away after the 12-month of trial period for conception, the patient can continue insulin pump therapy until the pump is needed for another patient.

Eligibility Criteria:
Inclusion Criteria:

1. Female diagnosed with Diabetes Mellitus Type 1
2. Subject indicated by HCP to start insulin pump therapy (CSII) or sensor augmented pump therapy (SAP) due to the desired or established pregnancy
3. HCP has prescribed the use of Orchestra donated device to the subject independently of the study
4. Signed Patient Informed Consent (PIC)
5. Subject is 18 to 45 years old, planning immediate pregnancy (within the next 12 months) or being pregnant within the first trimester until the 16th week of amenorrhea
6. Subject has been on MDI for at least 3 months before starting pump therapy

Exclusion Criteria:

1. Subject was enrolled in the registry earlier, and terminated it (for any reason)
2. Participation in any other interventional clinical trial - currently and/or in the last 3 months before the signature of PIC
3. Subject uses an insulin pump that was not donated by the Orchestra Foundation
4. Pregnant women with longer than 16 weeks of pregnancy/amenorrhea
5. Subjects who need assisted in vitro fertilization
6. Subjects with Diabetes Mellitus Type 2, Gestational Diabetes, MODY or any other type of diabetes than Type 1
7. Subject under the age of 18
8. Subject legally incompetent
9. Subject cannot read or write
Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers

The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of \>110 lbs.
* Otherwise healthy

Exclusion Criteria:

* Women must be of non-childbearing potential.
* Significant current or history of medical illness.
Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD

The purpose of this study is to determine the prevalence and severity of extrapulmonary disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and mortality of COPD patients.

Furthermore the investigators evaluate the relationship between systemic inflammation and organ involvement.

Chronic diseases and comorbidities have an increasing impact on individual life and health care use, as exemplified in chronic obstructive pulmonary disease (COPD). Currently, independent, comprehensive databases allowing for an integrated view are lacking. The study will for the first time establish a large, comprehensive longitudinal database covering a broad panel of comorbidities an markers of systemic alterations. These data will be of unique value in revealing specific phenotypes of COPD via patterns and risk profiles of comorbidities, enabling a more precise diagnosis and targeting of therapy, and an efficient allocation of resources.

Eligibility Criteria:
Inclusion Criteria:

* aged 40 years and older
* diagnosis of COPD (GOLD-Criteria) or chronic bronchitis
* informed consent
* available for repeated study visits pver 18 months

Exclusion Criteria:

* having undergone big lung surgery (e.g. lung reduction, lung transplant)
* Moderate or severe exacerbation within the last 4 weeks
* having a lung tumor
* Unable to walk or to understand the intention of the project
Outcomes of Focal Ablation for Prostate Cancer

This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

There are several commercially available standard of care treatments available for local therapy of the prostate. Ablative therapies may be delivered via a whole gland or focal approach by systems including cryoablation (CA), brachytherapy, irreversible electroporation (IRE), high intensity focused ultrasound (HIFU), MRI-guided transurethral ultrasound ablation (TULSA) procedure or future novel prostate ablation systems.

These are single, outpatient treatments lasting between 2-4 hours and include treatment planning and energy delivery under guidance and are either administered via transperineally approach (cryoablation, IRE, brachytherapy) or via the urethral (TULSA-Pro) or rectum (HIFU).

This study protocol will not include experimental therapy and the enrolled subjects will undergo the ablative therapy as part of their standard of care treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy
* Men with histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging excluding locoregional or metastatic disease
* Age 18-90 years.
* Life expectancy \> 1 year
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Anatomic abnormalities that do not allow for focal ablation
* Evidence of non-organ confined disease that is not feasible for ablation
* Has active urinary traction infection
TACE-HAIC Plus Atezolizumab and Bevacizumab for Unresectable HCC: a Phase 2 Clinical Trial

Transartial chemobolization plus hepatic artery infusion chemotherapy showed performance for unresectable hepatocellular carcinoma (HCC). Whether the additional of atezolizumab plus bevacizumab will improve the response rate for those patients is still unknown. This phase 2 clinical trial aims to investigate the objective response rate for unresectable hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* (a) patients were diagnozied with unresectable HCC,
* (b) Child-Pugh A or B liver function;
* (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* (e) adequate hematologic blood counts (white blood cell count \>3ⅹ109/L, absolute neutrophil count \>1.5ⅹ109/L, platelet count \>10ⅹ109/L, hemoglobin concentration \>85 g/L);

Exclusion Criteria:

* (a) severe underlying cardiac, pulmonary, or renal diseases;
* (b) history of a second primary malignant tumor;
* (c) contraindication to either atezolizumab and bevacizumab.