cyrilzakka/clinical-trials huggingface dataset:
Resilience for Young People With ADHD - a Randomized Controlled Trial of a Brief Intervention Program.

In this project we invite 8.000 young persons (age 18-27) in Denmark and to participate in a randomized controlled intervention study where we aim to test the effectiveness of a web based knowledge and inspiration program about resilience for children, adolescents and adults (called myresilience.org). The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Eligibility Criteria:
Inclusion Criteria:

A random sample with 8.000 patients registered in the Danish National Patient Register:

* Age 18-27
* ADHD diagnosis

Exclusion Criteria:

• Request for legal protection against contacts from researchers.
Clinical Hypnosis During Insemination or Embryotransfer

Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction techniques are required?


Eligibility Criteria:
Inclusion Criteria:

Planned insemination or embryo transfer

Exclusion Criteria:

under age not able to understand German
Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or metastatic colorectal cancer.

OBJECTIVES: I. Determine the response rate and survival of patients with recurrent or metastatic colorectal carcinoma treated with fluorouracil (5-FU), leucovorin calcium, and gemcitabine. II. Evaluate and establish the toxic effect profile of 5-FU, leucovorin calcium, and gemcitabine in these patients.

OUTLINE: This is a dose escalation study. Patients receive intravenous leucovorin calcium for 60 minutes and bolus infusions of fluorouracil (5-FU), followed by gemcitabine infusions, weekly for six weeks followed by 2 weeks of rest. The dosage of gemcitabine is increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities. Phase II proceeds at the maximum tolerated dose (1 dose level below that at which 3 patients experience grade 3-4 toxicities). Patients receive a minimum of two courses of treatment to be considered evaluable for response. Patients with stable disease, partial, or complete remission may continue therapy for up to six treatment cycles. Patients exhibiting disease progression or intolerable toxic effects are removed from the study.

PROJECTED ACCRUAL: A total of 63 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic primary colorectal carcinoma Must have measurable disease (evaluable disease acceptable in Phase I)

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-3 Life Expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL OR 3.0 mg/dL in patients with liver metastases Liver enzymes no greater than 3.0 times upper limit of normal (in patients with liver metastases) Renal: Not specified Other: Not pregnant or lactating Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy for metastatic disease allowed Prior treatment with 5-FU allowed Prior treatment with irinotecan allowed Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy (measurable disease must be located outside the prior radiotherapy portal) Surgery: Not specified Other: Prior treatment with folinic acid allowed
A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B

The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.

Total of 439 patients with chronic hepatitis B were divided according to patients' intention into two arms. 173 patients in arm I were treated with medical ozone therapy with humares which was made in Germany for at least 12 weeks.266 patients in arm II were treated with conventional interferon-α for at least 24 weeks.Patients in both groups were followed-up for 24 weeks.Virology response, biochemistry response and hepatitis B viral serological response will be studied at 12 weeks after the treatment, at the end of treatment and after 24 weeks of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or female；
* HBsAg positive for over 6 months；
* ALT over 2×ULN, TBIL less than 80 µmol/L.

Exclusion Criteria:

* Patient has a history of hemorrhagic or hemolysis disease;
* Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
* Patient is co-infected with HIV or HCV;
* Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
* Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
* Pregnancy;
* Current alcohol or drug abuse;
* Difficulty to draw blood through veins;
* Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
* Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
* Patient is enrolled in any other clinical trials.
Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults

Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.


Eligibility Criteria:
Primary Inclusion Criteria:

* Poor near vision impacting daily living that requires near correction
* Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better
* Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D
* Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive

Primary Exclusion Criteria:

* Diagnosis of glaucoma or ocular hypertension
* Narrow iridocorneal angles
* History of intraocular surgery, refractive surgery, laser treatment, or iris surgery
* Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris
* Presence/history of a severe/serious ocular condition or any other unstable medical condition
* Presence or history of manifest strabismus, amblyopia, or nystagmus
* Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears
* Clinically significant external ocular inflammation within 30 days of Screening Visit
* Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit
* Known pilocarpine allergy or contraindication to use of pilocarpine
* Presence or history of congenital heart anomaly, valve disease, or other cardiac disease
* Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet
Safety and Health Intervention Project

Use of opioid medications for treatment of pain has increased greatly in the U.S., with the average quantity of prescribed opioids increasing 700% in a decade, from \~100 morphine milligram equivalents (MME) per person to \~700 MME per person from 1997 to 2007. There have been concurrent increases in opioid-related adverse outcomes, such as extramedical use, opioid use disorders, and overdose. As a result, there were more unintentional poisoning deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640). Additionally, the number of Americans seeking treatment for opioid use disorders has increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530% increase.

The specific aims of this project are to: (1) Refine a motivational enhancement prevention intervention for prescription opioid overdose risk reduction and improved witnessed overdose response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized controlled trial comparing the prescription opioid overdose prevention intervention to a supportive educational control condition for patients in addictions treatment in order to: (a) obtain information about the feasibility of randomized controlled procedures; and (b) determine the distribution and variability of the primary (overdose risk behaviors) and mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk, knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection of prescription opioids) over follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and older in treatment at CPI
* able to provide informed consent.

Exclusion Criteria:

* acute suicidality
* psychiatric condition that precludes participation in the intervention
* inability to speak and understand English
* inability to give informed, voluntary, written consent for any reason
The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery

Awareness during anesthesia with intraoperative memory occurs when the patient is able to process information and produce specific responses to several stimuli. Anecdotal evidence suggests that children exposed to therapeutic suggestion consisting of gently encouraging, positive words spoken to them during emergence from anesthesia seem to arouse after surgery with less agitation, less pain and lower requirements for pain medications. Therapeutic suggestion has been associated with positive results in some adults during surgery, but it is unknown how therapeutic suggestion affects children. A newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development. Additional evidence, revealed that at least as early as 4 months of age, infants process auditory stimuli from their mother's voice at a higher amplitude than they process auditory input from female strangers, suggesting that maternal voice stimuli undergo a unique form of cerebral processing that lends support for the existence of neurophysiologic mechanisms that reflect a child's preference for his/her mother's voice. This study aims to evaluate and compare the possibility of intra-operative awareness prevention by using either music listening or maternal sound listening in children undergoing cardiac surgery.

children (4 to 8 years) undergoing repair of Atrial Septal Defect (ASD). Patients will be randomized into two groups (music group and maternal sound group); in music group patients listened to a recorded CD by music and songs preferred by the child, while in maternal sound group patients listened to a recorded CD where the mother singing the most popular songs their children like or telling a story to their children. In both groups bi spectral index (BIS) to detect depth of anesthesia. An interview will be conducted with the patients and their parent within the first postoperative week by a semi-structured in-depth questionnaire to evaluate occurrence of awareness.

Eligibility Criteria:
Inclusion Criteria:

* patients in the age range 4-8 years scheduled for elective cardiac surgery for Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass

Exclusion Criteria:

* Patients with previous cardiac surgery, diabetes mellitus, hearing impairment and psychiatric or neurological illness were excluded from this study.
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)

Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD) (Modified Hinchey's classification grade II non-responder to conservative therapy and grade III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give better results in patients with CAD

In the literature, there is no consensus about the role of the laparoscopic peritoneal lavage in the management of complicated acute diverticulitis. Recently, three important prospective randomized-control studies (SCANDIV, LOLA, DILALA) have reported contradicting conclusions, as two of them (SCANDIV and LOLA) state that LPL is not superior to sigmoidectomy for the high reoperation rate and morbidity, while DILALA confirms that LPL is feasible and safe in the short-term. To our knowledge, no international guidelines promote the use of LPL in complicated acute diverticulitis. We believe this technique could be safely used in a selected cohort of patients and, in some circumstances, could represent a "bridge" to a possible planned resection. The aim of the study is to collect and analyze the multicentric data of the LPL and LS and give a substantial contribution to the scientific community about this very debated topic.

Eligibility Criteria:
Inclusion Criteria:

* Acute abdominal pain,
* Signs of localized or diffuse peritonitis
* Signs of suspected perforated diverticulitis (diagnostic imaging)
* Signed informed consent

Exclusion Criteria:

* Septic shock
* Immunodepression
* Previous multiple abdominal surgical operations
* Modified Hinchey's grade IV
Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial

The clinical trial is designed as a prospective, multi-center, double-blind, randomised, placebo-controlled, interventional trial to assess safety, tolerability and efficacy of Adrecizumab (on top of SOC) in patients with COVID-19, and to evaluate if improvement of vascular integrity with Adrecizumab on top of SOC is superior to placebo/ control substance (NaCl 0.9%) on top of SOC in reduction of morbidity and mortality endpoints in patients with COVID-19.

The main reason for admission to ICU and need for mechanical ventilation of these patients is acute lung injury within a broad pneumonic spectrum, increased ventricular filling pressures and resulting congestion. It is hypothesized, that Adrenomedullin (ADM) is a key player in the (dys)-regulation of vascular integrity (Figure 2). Adrecizumab is the first-in-class humanized monoclonal anti-Adrenomedullin antibody, and acts as a long-lasting plasma Adrenomedullin enhancer stabilizing barrier function at a reasonable safety profile. The mode of action for the anti-Adrenomedullin antibody Adrecizumab has been developed on the basis of published data, own experimental data and theoretical considerations.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization with moderate to severe COVID-19, defined as fulfilling at a minimum the following clinical status category on the WHO 8-point ordinal scale: (i) "score 4" \[oxygen via mask or nasal\]
* Laboratory-confirmed SARS-CoV-2 infection at index hospitalisation as determined by PCR or other validated commercial or public health assay
* Bio-ADM ≥50 pg/mL or ≥30% increase until the end of the next day (with a minimum of 35 pg/mL at all)
* DPP3 ≤30 ng/mL
* Age ≥18 years at time of screening
* Body weight ≤ 150 kg at time of screening

Exclusion Criteria:

* Life expectancy less than 3 months before COVID-19 at the discretion of the Investigator
* Invasive mechanical ventilation ≥ 72 hours at time-point of randomization
* Resuscitation \> 45 minutes
* Hypersensitivity to the active substance, to Adrecizumab or any of its excipients, or known serious hypersensitivity to other monoclonal antibodies
* Uncontrolled haematological/ oncological malignancies
* Pre-existing severe chronic liver disease (i.e. Child-Pugh C) before COVID-19 hospitalization
* Absolute neutropenia \<500 per μL
Diffusion-Weighted MRI for Liver Metastasis

The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM).

The advancements of systemic and local therapies for complex CRLM have led to the increased incidence of DLMs. It is hypothesized that DW-MRI imaging could distinguish between a metastasis not completely sterilized by conversion therapy and a sterilized scar (non-viable tumor). If this can be demonstrated, the use of DW-MRI could make a significant impact on the surgical decision making process by providing surgeons a more reliable guide to decide whether to leave behind or to resect/ablate a site of DLM. Most importantly, this surgical choice can also have a significant impact on patient outcomes as it may impact the risk of local recurrence and the need for re-operation.The possibility of improving surgical management of complex CRLM is foreseen if the benefit of observing or resecting small residual metastases and DLMs is clarified through a multi-center and international prospective study.

Eligibility Criteria:
Inclusion Criteria for Eligibility:

1. Contrast-enhanced thorax, abdomen and pelvic CT scan (with at least portal venous phase for the liver) at diagnosis and right before surgery are available
2. Multiparametric MRI at baseline and right before surgery are available (T1/T2, DW-MRI and contrast enhanced MRI).
3. WHO performance status of 0 or 1
4. Previous treatments (chemotherapy, surgery) for primary, liver and extra-hepatic metastases are allowed.
5. No other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer gleason score ≤ 6, and basal/squamous cell carcinoma of the skin
6. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study

Criteria for Enrollment

1. Conversion therapy is either being given or completed
2. Patient is suitable for hepatic resection based on the assessment of MDT composed of at least an expert liver/colorectal surgeon, Gastrointestinal (GI) radiologist and oncologist prior to any liver surgery
3. Hepatic resection is scheduled to take place within 8 weeks of latest imaging

Exclusion Criteria:

1. Contraindications to any contrast agents for CT and MRI or MRI procedure
2. Pregnancy
3. Significant comorbidity that will preclude either conversion therapy or surgery
Visual Acuity After the Combined Binocular Implantation of +2.0 Diopters and +3.0 Diopters Oculentis Multifocal Intraocular Lenses.

The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses.

Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.

Eligibility Criteria:
Inclusion Criteria:

* clinically significant cataract
* endothelial cell count: patients aged 18-75 years: \> 1000 cells/mm2; patients \> 75 years: \> 750 cells/mm2
* absence of vision-limiting corneal or retinal comorbidities
* capability to understand the informed consent

Exclusion Criteria:

* expected postoperative astigmatism \> 0.75 diopters
* irregular astigmatism
* dilated pupil diameter \< 3 mm
* corneal and fundus abnormalities that might cause visual impairments
* inability to attend follow-up visits
Effect of Growth Hormone in Metabolic Syndrome

Investigating the effect of low dose growth hormone therapy on body fat composition, insulin sensitivity and metabolic profiles in middle-aged men with metabolic syndrome and low insulin-like growth factor (IGF-1) level.

Metabolic syndrome, a constellation of glucose intolerance, hypertension, dyslipidemia, obesity, pro-inflammatory and prothrombotic state culminating to development of premature cardiovascular diseases is a serious public health problem with significant impact on life expectancy, societal productivity and quality of life of those afflicted with it. Insulin resistance has been proposed as the key linking factor for the metabolic syndrome. Although the underlying mechanism for the development of insulin resistance, diabetes and metabolic syndrome is not fully understood, increasing evidence suggests that neurohormonal dysregulation plays a pivotal role in causing this growing health hazard. In our previous study of 307 middle-aged men, low insulin-like growth factor (IGF)-1 level was independently associated with insulin resistance and metabolic syndrome, especially amongst those with positive family history of diabetes. Replacement with growth hormone has been shown by other researchers to reduce body fat and improve metabolic profiles in patients with adult growth hormone deficiency and type 2 diabetes.

We hypothesize that treatment with growth hormone can lead to reduction of body fat, insulin resistance and cardiovascular risk factors in men with metabolic syndrome. This will be a 12-month prospective, randomized, double-blind, placebo-controlled study using growth hormone treatment in middle-aged men with metabolic syndrome. The primary outcome measure will be body fat distribution, including changes in visceral and mesenteric fat, whereas secondary outcome measure will be insulin sensitivity, and tertiary outcome will be variable parameters of metabolic syndrome.

The results of this study will have important impact on the treatment of patients with metabolic syndrome, and our understanding of the role of growth hormone in the pathogenesis of insulin resistance, diabetes and metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age 35 to 50 Chinese men
* Metabolic syndrome as defined according to 1998 World Health Organisation with modification using Asian definition for obesity (body mass index 25kg/m2, waist circumference 80cm in women and 90 cm in men)
* Low IGF-1 level or IGF-1 level in low normal range (\<200 ug/L)

Exclusion Criteria:

* Any malignancy within the past 5 years
* A diagnosis of acromegaly
* Uncontrolled hypertension (systolic blood pressure \>180mmHg or diastolic blood pressure\>105mmHg)
* A history of carpel tunnel syndrome
* Poor glycemic control (HbA1c\>8%)
* Diabetic microangiopathy
* Previous cardiovascular event
* Anaemia as defined as haemoglobin \<11g/dL
* Active thyroid diseases
* Any medical illness that will render the subject vulnerable to fluid retention state, e.g. renal impairment, heart failure or as judged by the investigators as ineligible to participate the study.
An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)

The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).


Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients who are between the ages of 18 and 64

Exclusion Criteria:

* Adults who do not have a diagnosis of insomnia (a sleep disorder)