cyrilzakka/clinical-trials huggingface dataset:
Online Intervention for Depression: MOOD

The study aims to examine the efficacy and acceptance of a self-help internet intervention "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive symptomatology decreases in the intervention group compared to a wait-list control group. Further aims are to ascertain changes in self-worth and quality of life, to assess subjective evaluation of the program and to examine whether expectations of the program's helpfulness would predict symptom reduction.

The study aims to examine the efficacy and acceptance of a self-help internet intervention "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive symptomatology decreases in the intervention group compared to a wait-list control group. Secondary aims are to ascertain changes in self-worth and quality of life, to assess subjective evaluation of the program and to examine whether expectations of the program's helpfulness would predict symptom reduction. During the intervention period of six weeks, participants of the intervention group have access to the online program MOOD. Prior and following this period both groups complete a pre- and post-assessment. Participants of the wait-list control group receive access to MOOD following the post-assessment.

Eligibility Criteria:
Inclusion Criteria:

* presence of psychological strain and desire for treatment for depressive symptoms
* internet access
* sufficient command of the German language

Exclusion Criteria:

* acute suicidality (as assessed with one item of the BDI)
* lifetime diagnoses of bipolar disorder and psychosis
Men's Experience of Prostate Biopsy

Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital may be invited to take part in one to one interview within 6 months of having the procedure done to talk about their experience

Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital will be approached by their Urology team or study Researcher with an information sheet about the study pre or post biopsy. The participant information sheet outlines that the study will involve being interviewed by the researcher, Kathryn Myhill as part of her doctoral research and being asked about their perceptions of their biopsy experience and what it was like to go through it. Men who return an expression of interest reply slip by post will be contacted by the researcher or they can contact her directly via the email or phone details given in the PIS. The researcher will answer any queries about the study and explore whether they would like to take part in an interview. A one to one interview will then be offered in a non-clinical, private room at the hospital where their biopsy took place (Royal Marsden Hospital, Epsom General Hospital) or at their workplace or home.

Eligibility Criteria:
* Inclusion Criteria:
* Men aged over 18 having a first or second diagnostic prostate biopsy at either the Royal Marsden NHS Foundation Trust or Epsom General Hospital
* Within 6 months of their prostate biopsy being done
* Exclusion Criteria:
* Men unable to give informed consent/ men needing a translator
Hypotension in Children With Down Syndrome With Anesthesia Induction

Children generally undergo induction of anesthesia by inhalation of sevoflurane. Children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.

Children generally undergo induction of anesthesia by inhalation of sevoflurane. This is particularly relevant for children with developmental delays as to avoid placement of an IV while awake. However, children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.

Eligibility Criteria:
Inclusion Criteria:

Children \<18 years old Requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3

Exclusion Criteria:

Patients \>18 years of age Patients without down syndrome Cyanotic congenital heart disease Use of antihypertensive medications Pulmonary hypertension patients undergoing intravenous induction of anesthesia ASA physical classification other than 1-3 emergency procedure
Intrapartum Hydration

The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour.

During labor it is a common practice that the parturient is fastening and having fluid replacement through intravenous hydration (IVH), the rational being to avoid aspiration of gastric content in a situation of need for urgent intervention and general anesthesia with tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution that does not contain sugar, but the volume is not adjusted to the weight of mother, the level of effort or relaxation she is experiencing and it may well be below the required amount. From studies in the field of sport medicine it is clear that the amount of fluid reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and the level of personal achievement in sports. Only few studies dealt with the amount and contents of IVH during labor that will be sufficient and meet all physiologic requirements of the parturient and her fetus.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* Gestational age 37-41 weeks
* Cervical dilatation 1-3 cm
* Vertex presentation
* Singleton

Exclusion Criteria:

* Diabetes
* Preeclampsia
* Intra uterine fetal growth restriction
* Duration of labor less than an hour
* Maternal chronic disease
* Maternal fever upon admission.
Transcutaneous Oxygen Pressure (TcPO2) Determination.

Upper limb arterial disease is a rare condition compared to lower limb arterial disease. In the lower limb, chronic limb ischemia (CLI) is characterized by an intractable pain or an ulceration present for at least 2 weeks. Guidelines recommend to use Transcutaneous Oxygen pressure (TcPO2) measurement when a CLI is suspected to establish diagnostic with a threshold of 30 mmHg when ankle and toe systolic pressure are not available.

In the upper limb, there is no guideline to define CLI. When there is a wound preventing finger pressure measurement, TcPO2 is theoretically indicated. However, there is neither standardized site to measure nor threshold value of TcPO2.

The investigators hypothesized that normal TcPO2 may be different in the upper limb and that threshold value for CLI may also be different compared to lower limb.

The investigators planned a study with two parts:

1. Prospective study of normal TcPO2 value in healthy volunteers
2. Retrospective analysis of patients with upper limb arterial disease to approach the TcPO2 threshold of CLI allowing healing in upper limb


Eligibility Criteria:
Healthy volunteers part:

Inclusion Criteria:

* healthy volunteer without upper limb arterial disease
* absence of opposition
* affiliated to social insurance

Exclusion Criteria:

* under 18 yrs old
* under law protection
* pregnancy

Retrospective patients part:

Inclusion Criteria:

* patients with a TCPO2 measurement available for the upper limb
* patients with a follow-up of at least 3 months available
* absence of opposition
* affiliated to social insurance

Exclusion Criteria:

* under 18 yrs old
* under law protection
* pregnancy
Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications

Elective spine surgery is associated with a high incidence of perioperative complications, including peri- and postoperative pulmonary complications (PPCs), which occur in nearly 4% of patients. More than 40% of all deaths after elective spine surgery are attributed to PPCs. However, whether it influences risk of other PPCs is unclear.


Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they underwent elective spine surgery (e.g. multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020

Exclusion Criteria:

* combined anterior-posterior surgery
* growth rod adjustment surgery
* spinal tumor.
* surgery took fewer than 3 hours.
Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery

The goal of this observational study is to observe the correlation between dynamic changes in the Doppler-based renal resistive index (RI) and the occurrence of persistent acute kidney injury (AKI) in critically ill patients. The main questions it aims to answer are:

* Are dynamic changes of RI within 24 or 48 hours associated with the prognosis of AKI (NO AKI, transient AKI, persistent AKI)?
* what are the influencing factors of changes in RI? Participants will measure values of RI in patients at admission (0 hour), after 24 hours and after 48 hours, respectively, and collect characters such as age, sex, vital signs, Apache II, diagnosis, renal function, applied drugs, fluid, 72-hour renal function and renal replacement, followed renal replacement and the mortality rate at 28 days.

NO AKI is defined as No AKI occurred within 72 hour after ICU admission; Transient AKI is defined as AKI with recovery, which refers to the reduction in AKI stage ( (i.e., a decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy) occurring with 72 hour after ICU admission; Persistent AKI is defined as AKI without recovery occurring with 72 hour after ICU admission.

Eligibility Criteria:
Inclusion Criteria:

• Patients admitted to the ICU within 24 h of admission.

Exclusion Criteria:

* Chronic kidney disease stage III-V;
* History of kidney transplantation;
* Previously known renal artery stenosis or renal vein thrombosis；
* Cardiac arrhythmia precluding renal Doppler measurement;
* Expected hospital stay \< 72 h；
* Pregnant patients
* Last, patients with hospital stays \< 72 h, since they could not be classified as having transient or persistent AKI according to our definitions, were secondarily excluded.
Phase I FOLFOX Combination

A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)
2. WHO performance status 0-1
3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques

Exclusion Criteria:

1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
3. prior unanticipated severe reaction to oxaliplatin
Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures

The purpose of the study is to assess the safety of Progesterone Vaginal Ring (PVR) in women undergoing fresh embryo transfer (ART).


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal women aged 18-34 at the time of consent.
* Documentation of a normal uterine cavity by hysteroscopy, hydrosonogram, or hysterosalpingogram within one year of screening.
* Normal Pap smear test within 24 months of screening.
* At least one cycle without reproductive hormone medication prior to screening follicle-stimulating hormone (FSH) and estradiol blood draw.
* Tubal, idiopathic, male factor, ovulatory dysfunction, or endometriosis-linked infertility.

Exclusion Criteria:

* Body mass index greater than 38 kg/m\^2.
* FSH greater than 15 IU/L during the early follicular phase (Day 2-4). For those participants with polycystic ovarian syndrome, a Day 2-4 FSH level can be obtained following a progestogen withdrawal or spontaneous menses.
* Clinically significant gynecologic pathology, such as submucosal fibroids, intramural fibroids \>5 cm, communicating hydrosalpinx, uncorrected uterine septum, endometrial cancer or endometrial atypia, scar tissue inside the cavity or poorly developed uterine lining from prior uterine surgery, pelvic tuberculosis, or any other conditions that could adversely affect pregnancy success.
* Uncontrolled elevation of prolactin or too little thyroid hormone in the blood.
* History of more than one failed fresh in vitro fertilization cycle. A failed cycle is defined as having started a cycle and not becoming pregnant or pregnancy loss prior to the 20th week of pregnancy.
Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)

The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing pain associated with post-herpetic neuralgia.

This is a Phase 2a proof of concept study evaluating the safety/efficacy of retigabine vs. placebo in patients with post-herpetic neuralgia. After screening, patients will enter a maximum 6 week titration period followed by a 4 week maintenance period and a 3 week taper phase.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Male or female subjects
* 18-85 years of age
* PHN for more than 6 months after the healing of herpes zoster skin rash
* Has a pain score at screening and randomization that qualifies

Exclusion Criteria:

* Other significant pain that may potentially confound PHN pain assessment
* Previous neurolytic or neurosurgical therapy for PHN
* Subject has evidence of a progressive central nervous system (CNS) disease (e.g. CNS lupus, tumors, multiple sclerosis, Alzheimer's), lesion, or encephalopathy
* Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or recent history of suicidal ideation
* Has clinically significant abnormalities on physical examination, vital signs, ECG, or laboratory tests at the screening visit
Optimal Suture Choice for Improved Scar Outcomes

Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads to significant widening of the final scar. Historically, the only way to combat this tension was to support the deeper portion of the wound with sutures that dissolve over several weeks. However, scars take many months to fully develop their greatest strength. So even with the standard technique, wounds in areas of high tension still show spreading of the scar with time. The investigators believe that these wounds require an extended duration of support throughout the scar's maturation period. Until recently, there did not exist a suture that could provide this long duration of support without also carrying the risk of the body rejecting it. Recently, a new extremely long acting absorbable biomaterial has been FDA approved for use as a suture. The investigators plan to use this suture to test the theory that alleviating stress on high tension wounds throughout the period which they gain their maximal integrity produces less scar spread and ultimately better cosmetic outcomes.


Eligibility Criteria:
Inclusion Criteria:

Patients requiring excision of a lesion on chest, back, or shoulders

Exclusion Criteria:

* History of ionizing radiation
* History of keloid or hypertrophic scarring
* History of or current internal malignancy
* History of bleeding disorder
* History of collagen or elastin disorder
* Current use of immunosuppressive medications
Is Adipose Tissue a Reservoir for SARS-Cov2 Spread in Covid-19 Patients?

Resident cells of human adipose tissue express ACE2 and DPP4, receptors for SARS-Cov2. The hypothesis is that the virus may enter and spread in fat depots.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years old
* Patients testing positive for Covid19
* Patients affiliated to social security
* Signing of free and informed consent

Exclusion Criteria:

* Vulnerable persons (- minors,
* adults under guardianship or curatorship,
* pregnant women,
* persons deprived of their liberty,
* persons who do not master the French language)
Digital Intervention for Depression and Anxiety in Adolescents

The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.

Participants will be asked to engage with the digital intervention platform for a period of two months.


Eligibility Criteria:
Inclusion Criteria:

* The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the DSM-5(the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).
* having a HAMD(Hamilton Depression scale) score upon enrollment
* demonstrate normal cognitive function.
* voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.

Exclusion Criteria:

* with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning
* with concurrent psychiatric disorders (as determined by clinical assessment)
* with concurrent psychiatric disorders (as determined by the assessing clinician)
* at high risk of suicide
Study of Acarbose in Longevity

The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.

Acarbose, an FDA approved drug for the treatment of type 2 diabetes, has known effects on glucose metabolism. Evidence from mice indicates that acarbose may prolong lifespan. In humans, acarbose improves inflammatory markers and reduces cardiovascular events. Consequently, acarbose is of interest in clinical translational aging research since it may influence fundamental processes that contribute to age-related diseases. The study described herein is an exploratory study to examine the effect of acarbose treatment on the biology of aging in humans. Specifically, the investigators plan to study whether treatment with a 10 week course of acarbose will alter the gene expression profile in adipose tissue and muscle in older adults in pathways that are known to be affected by human aging, in a placebo-controlled crossover study.

Eligibility Criteria:
Inclusion Criteria:

* Male
* age \>60 years
* impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)

Exclusion Criteria:

* cancer
* heart failure
* COPD
* inflammatory conditions
* eGFR\<45
* active liver disease
* poorly controlled hypertension
* epilepsy
* recent cardiovascular disease event (last 6 months)
* inflammatory bowel disease
* history of bariatric or other gastric surgery
* cigarette smoking
* serious substance abuse.
* Treatment with drugs known to influence glucose metabolism
* Hypersensitivity to acarbose or any component of the formulation.
* Treatment with anti-coagulant medications or anti-platelet drugs
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial

The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101.

The main questions it aims to answer are:

* Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)?
* What medical problems do participants have when taking ARD-101?

Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects.

Eligible participants will:

* Take ARD-101 or a placebo every day for 12 weeks.
* Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo.
* Patients/Caregivers will keep a daily diary.


Eligibility Criteria:
Inclusion Criteria:

* Documented confirmation of Prader-Willi Syndrome (PWS)
* Stable care setting with same, single designated caregiver for at least 6 months prior to Visit 1

Exclusion Criteria:

* Diagnosis of schizophrenia, bipolar disorder, personality disorder or other severe mood, anxiety or eating disorder (other than hyperphagia).
* Presence of any malignancy within 5 years with the exception of basal or squamous cell carcinoma of the skin, in situ carcinoma of the service, or in situations prostate cancer.
* Presence of clinically relevant renal, hepatic, pancreatic, cardiovascular, neurological, psychiatric, hematological, pulmonary, or GI abnormality that, in the opinion of the investigator, may preclude the patient from safe completion of the study
* Adults: systolic blood pressure \>=160 mmHg and/or diastolic blood pressure \>=100 mmHg
* Children and Adolescents: systolic blood pressure \>=140 mmHg and/or diastolic blood pressure \>=90 mmHg.
* Type 1 diabetes mellitus; HbA1c \>8.5%
* Use of agents to promote weight gain or loss, alter hunger or appetite within 30 days of Visit 1 and throughout the study.
* Use of glucocorticoids: oral, intra-articular, or intravenous