cyrilzakka/clinical-trials huggingface dataset:
Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools

This study will be a randomized controlled trial on the effects of group-based LM as an intervention for depression. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM intervention with self-tracking tools (LM/S), pure LM intervention (LM), or care-as-usual (CAU) control group in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. In order to obtain unbiased data with respect to the participants' attitudes and behaviors, incomplete disclosure will be used to withhold the self-tracking component in this trial. Participants in the two LM groups will receive six weekly group lifestyle modification sessions (\~2 hours each) at the Chinese University of Hong Kong (an online approach will be adopted if face-to-face sessions are not possible due to COVID-19). The group treatment will primarily be delivered by clinical psychology trainees under the supervision of a clinical psychologist and other healthcare professionals such as a dietitian and a fitness trainer. The CAU group will continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments. Both the treatment groups and control group will complete a set of online questionnaires before the treatment commences, immediately after treatment, and 12 weeks after the treatment sessions are completed. In addition, participants in the LM/S group will complete a set of self-developed survey questions related to lifestyle and mood on a daily basis.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged ≥ 18 years
2. Cantonese language fluency and readability
3. A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression
4. Possession of an internet-enabled mobile device (iOS or Android operating system)
5. Willingness to provide informed consent and comply with the trial protocol

Exclusion Criteria:

1. Current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score \> 2 (referral information to professional mental health services will be provided)
2. Any medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise or a change in diet are not recommended by physicians)
3. Current involvement in lifestyle changes supervised by professionals
4. Unstable medication or current participation in any psychotherapy for depression
5. Pregnancy
6. Hospitalization
7. Current participation in any other trial(s)
A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood

The main objective of Part 1 of this trial is to investigate the absolute bioavailability of BI 1358894 with an intravenous microdose formulation containing labelled \[C-14\] BI 1358894 and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects.

The main objective of Part 2 of this trial is to investigate the relative bioavailability of BI 1358894 administered as an oral suspension.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 90 days after trial completion:
* Use of adequate contraception of the female partner, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first study drug administration or barrier method (e.g. diaphragm with spermicide) or,
* Sexually abstinent or
* A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or
* Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy) or
* Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH (follicle stimulating hormone) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm
* C-reactive protein (CRP) \> upper limit of normal (ULN), liver or kidney parameter above ULN
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply
Oral Enteral Nutrition Feeding in Alzheimer's Patients

This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

The Alzheimer's disease in the elderly exhibits the high prevalence.This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 years and 85 years, meeting the diagnosis of Alzheimer's Disease.
* presence of no contraindication for enteral nutrition.
* with dysphagia verified by Imaging materials.
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications
* Minimum Mental State Examination ranging from 10-26

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders.
* complicated with other intracranial lesions, such as stroke.
* abnormal structure of swallowing-related organ and tissue.
Innovative Spinopelvic Solutions with Real-World Evidence

INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 at time of screening.
2. Patient will undergo a procedure utilizing an iFuse Implant family product.
3. Patient is comfortable communicating in written and spoken English.
4. Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer.
5. Patient is willing and able to provide informed consent to participate

Exclusion Criteria:

1. Patient has fibromyalgia.
2. Patient has a pain pump.
3. Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.

The main purpose of this study is to evaluate the postoperative effect of erector spinae block in patients undergoing nephrectomy that causes both visceral and somatic pain.

After being informed and potential risks about the study, all patients have given written consent will undergo 24 hours screening for the analgesic effect of erector spinae block after nephrectomy. Patients meeting the criteria were randomly selected in double-blind manner 1:1 ratio to erector spiane block or not.

Eligibility Criteria:
Inclusion Criteria:

1. To undergo partial or total nephrectomy surgery
2. To be in ASA I-II classification
3. To be between the ages of 18-65.
4. Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly.
5. Being in good mental and psychological health
6. To accept to participate in the study.

Exclusion Criteria:

1. Being in ASA III or IV class with a high risk of anesthesia
2. Being outside the age range of 18-65
3. Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application.
4. Not being mentally and psychologically healthy
5. Those who are allergic to the active substance, patients using antiepileptic drugs
6. Those with severe hepatic and renal failure
7. Those who have long-term use of nonsteroidal anti-inflammatory and opioid analgesic,
8. Those with diabetes and other neuropathic diseases
9. Patients who cannot use patient-controlled analgesia (PCA) device
Socioeconomic Aspects Before and After Radiation Therapy in Patient With Prostate Cancer

This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous and interstitial radiotherapy are included. Beside medical effects and adverse events, it's prospectively needed to extensively inform patients about socioeconomic aspects associated with radiotherapy. The interrogation comprises to collect possible costs and expenditures during and after therapy. Aspects especially concerning post therapy period include additional consultations, individual applied alternative medical care, need for additional medical aids (salves, medicine, bandages) and changes in professional and social situation. It's figured out in what extend costs are absorbed by health insurance coverage. In Germany there is no appropriate trial with respective patient population and respective therapy. Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as changes in social and professional situation. Secondary endpoints are quality of life, adverse events of therapy and the correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage.


Eligibility Criteria:
Inclusion Criteria:

* minimal age 18
* low, mediate and high-grade prostate cancer

Exclusion Criteria:

* tumor recurrence
* surgery as primary therapy
* prior radiotherapy except conventional radiotherapy
* patients with other malignancies
Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose using pharmacology.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ages 18-45, with FXS who completed the study entitled "Mechanisms and brain circuits underlying fragile X syndrome" (IRB # 2015-8425) or appropriate baseline measures through Biorepository (2013-7327).
* FXS is defined as full FMR1 mutations (\>200 CGG repeats) confirmed by genetic testing.
* General good health as determined by physical exam, medical history and laboratory work up.
* Stanford Binet IQ \<85
* Stable dosing of psychotropic drugs for at least 4 weeks.

Exclusion Criteria:

* Subjects with a history of intolerance to baclofen, roflumilast, or memantine will be excluded.
* Subjects will also be excluded if they have taken any investigational drug within 3 months, have a history of substance abuse or dependence within 6 months, or significant psychiatric or CNS neurological disease unrelated to FXS.
* Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months
* Auditory or visual impairments that cannot be corrected based on visual and auditory screener benchmarks.
* Moderate to severe renal or hepatic impairment and determined by a study physician incorporating data from exam, medical history and laboratory value evaluation among other data points.
* Use of barbiturates, benzodiazepines, antiepileptics, or other GABAergic or glutamatergic modulators
* Current use of: Amifampridine, Butalbital, Codeine, Doxylamine, Ethanol, Hydrocodone, Isocarboxazid, Kava, Metoclopramide, Midazolam, Oxybate, Phenelzine, Promethazine, Thalidomide, Tranylcypromine, Trimethobenzamide, Erythromycin, Ketoconazole, Fluvoxamine, Enoxacin, and Cimetidine.
* Those taking other psychiatric medications must be on stable doses for 4 weeks before the baseline visit.
* Pregnancy or breast-feeding. For female subjects of child bearing potential, a urine pregnancy test will be performed.
* Potential subjects with a creatinine clearance \< 50 mL/min will be excluded.
* Identified medical issues, inability to tolerate study procedures or study drug per the discretion of the Principal Investigator.
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
* HCV RNA viral load of ≥100,000 IU/mL
* No previous exposure to interferon, pegIFNα, or RBV
* Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
* Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
* Body mass index of 18 to 35 kg/m\^2

Exclusion Criteria:

* Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
* Evidence of a medical condition associated with chronic liver disease other than HCV
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

The purpose of this study is to determine the acute and late toxicities from radiation therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2 years).

Although there is no data on the toxicity with concurrent bevacizumab and hormonal therapy, the combination is not expected to increase toxicity seen when given as a single agent. Abnormal tumor microenvironments, tumor progression, and metastatic spread are major factors contributing to treatment failures in radiotherapy. Anti-VEGF agents (e.g. bevacizumab) can help overcome these factors through several different mechanisims.

Studies also demonstrate prolonged use of anti-VEGF agents with radiation therapy was more effective at preventing metastases from irradiated tumors compared to a short course. Patients generally start hormonal therapy and daily radiotherapy at the same time. This study will delay the start of radiotherapy until 8 weeks after the start of hormonal therapy and bevacizumab.

Eligibility Criteria:
Inclusion Criteria:

* High Risk Prostate Cancer as defined as ONE of the following:

  1. Clinical T2b-T4
  2. Gleason sum score 8-10
  3. PSA more than 20 and Gleason sum score 7
  4. In addition, clinical T2a patients are eligible if 5 or more biopsies contain Gleason 4+3 cancer (minimum of 10 biopsies total required)
* No evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis
* ECOG performance status of 0, 1 or 2

Exclusion Criteria:

* Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
* Presence of central nervous system or brain metastases
* Blood pressure of \>150/100 mmHg
* History of myocardial infarction within 6 months
* History of stroke within 6 months
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas

A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.

A Growth Monitoring Study conducted according to FDA established guidelines to evaluate the test infant formulas ability to promote normal growth and development.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Term Infant

Exclusion Criteria:

* Any health condition that would negatively impact infant feeding and growth.
Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair


Eligibility Criteria:
Inclusion Criteria:

* Women aged above 18 yrs.
* Primiparous.
* Undergoing spontaneous vaginal delivery of a single full-term fetus.
* Vertex presentation.
* Having mediolateral episiotomy.

Exclusion Criteria:

* Body mass index ≥ 35 kg/m2
* Complicated delivery by any tears other than episiotomy or postpartum hemorrhage.
* Any risk factor causing increased stretch of the perineum; Operative vaginal delivery, fetal macrosomia.
* The use of epidural anesthesia.
* Previous perineal surgeries, local infection or lesions.
* Any medical condition that can cause excessive bleeding or impair wound healing; (cardiovascular disease, diabetes, anemia, coagulopathy, collagen disease or Immunosuppression).
* Contraindication or Hypersensitivity to any of materials used in the study.
Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions

An open label, single-center, balanced, randomized, two-treatment, two-sequence, four-period, full replicate, crossover, single dose, Phase I, oral comparative bioavailability study in healthy, adult participants (male subjects and female subjects of non-childbearing potential) under fasting conditions with a screening period of 21 days prior to enrollment. In each study period, 21 blood samples were collected from each participant to analyze the pharmacokinetic profile of the test as well as the reference drug.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males (sterile or using contraception) or females of non-childbearing potential 18 and 55 years of age
* Acceptable medical history, physical examination, laboratory investigations within 21 days prior to enrollment
* Clinical laboratory values were within the laboratory's stated normal range. If not within this range, they must be without clinical significance, as determined by the Investigator
* The subject is able to communicate meaningfully with study personnel and is anticipated to be able to comply fully with study procedures

Exclusion Criteria:

* Any history of impairment of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or disorder
* Participated in any other clinical study or donated blood in last 90 days
* Positive screens for serum hepatitis B surface antigen (HbsAg), hepatitis C antibody (HepC) or human immunodeficiency virus (HIV)
* Female subjects demonstrating a positive pregnancy screen, currently breastfeeding or using hormone replacement therapy within three months prior to dosing of test product
The Effect of the Treatment Program "Dr. Fedon Lindbergs Vektcoach" on Body Weight and Composition and Hormonal Profile

The background for the trial is a number of previous studies indicating that it is especially important to restrict the intake of carbohydrates when treating overweight and metabolic diseases in general.

The purpose of the study is to obtain research data on the effects of an established treatment of overweight/obesity and its related metabolic disorders. The treatment, "Dr. Fedon Lindbergs Vektcoach", is a combination treatment where patients use low carbohydrate and low energy "Eurodiet" products in the initial phases. After the initial phases are completed, low glycemic normal foods are added to the diet until a sustainable and healthy diet is achieved. The treatment is of 7 month duration.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI)\>35
* BMI\>27 + one risk factor for cardiovascular disease or metabolic syndrome
* \>18 years

Exclusion Criteria:

* Medicinal treatment of thyroid disease
* Pregnancy or planned pregnancy
* Taking of diet pills like Xenical or Sibutramine
Prevalence of Microcirculatory Alterations in Intensive Care Patients

Recent research has focused on the investigation of sublingual microcirculatory alterations in different patient categories, like cardiac surgery and sepsis. The microcirculation plays a pivotal role in tissue oxygenation and can be non invasively visualized by sidestream dark field (SDF) imaging.

The objective is to carry out a international multi center study to investigate the prevalence of microcirculatory alterations in intensive care patients. Up to the present time, a comprehensive prevalence study like this has not been carried out.

Visualization of the sublingual microcirculation at a fixed time point with SDF- or OPS-imaging in all adult patients of participating intensive care units, regardless of their underlying disease. Concurrently, data on both patient characteristics (e.g. severity of illness, treatment) and ICU characteristics will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* \> 18
* informed consent

Exclusion Criteria:

* injury to the maxillofacial area
* recent maxillofacial injury