cyrilzakka/clinical-trials huggingface dataset:
Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population

Quarantine is an unpleasant experience : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. It may lead to negative mental health consequences and thus the emergence of anxiety and depressive symptoms.

From March 17th, 2020 to May 11th 2002, the French government has implemented national containment measures due to the Covid-19 epidemic.

Although there are data on the psychological impact and experience of quarantine measures in people who have been infected or suspected of being carriers of certain pathogens (e.g. Ebola), there are no data on such impact in the French population and quarantines lasting longer than 21 days. Investigators therefore propose to conduct a human and social sciences study in order to better understand the current situation

The main objective is to describe the psychological state during confinement (and the impact of the confinement) in a sample of the French general population.

Secondary objectives :

* to assess the evolution of psychological health between the period of confinement and post-confinement.
* to identify clinical factors modulating psychological state during confinement

It is expected to highlight :

* a link between the intensity of anxiety symptoms and the number/quality of social contacts
* a reduction of anxiety and depression symptoms in the post-confinement period.
* higher consumption of drugs during the confinement period

Self-questionnaires (Google form format) are sent by mailing lists or social networks to participants in order to complete the assessment of psychological state. A unique identifier is sent in a separate email. These assessments are performed at least once during the confinement period. It is planned to repeat them when the confinement is lifted: 15 days, 3 and 6 months after the lifting of the confinement because of the risk of developing anxiodepressive symptoms, in particular post-traumatic stressors.

Eligibility Criteria:
Inclusion criteria:

- age\> 18

Exclusion criteria:

- protective measure (curatorship, guardianship)
Visionaire: A Prospective Study

The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system.

1. It is hypothesized that there will be no significant differences in position, loosening, or function of the Visionaire total knee as compared to the conventional total knee.
2. It is hypothesized that the Visionaire total knee will be significantly better with regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover time, and overall costs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA

Exclusion Criteria:

* prior TKA
* ipsilateral upper tibial or distal femoral osteotomy
* ipsilateral total hip arthroplasty
* patient with significant \>15o varus or valgus
* morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children

A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.

Investigators propose a prospective randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years. 25 subjects will be randomized to initiate a dose of 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week (0.18-0.22 mg/kg/week) for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 5-15 years
4. In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
5. Ability to take subcutaneous GH injections nightly

Exclusion Criteria:

Subjects will be excluded if they have GH resistance, or syndromic short stature such as Prader Willi syndrome and Turner syndrome. Patients will also be excluded if they have active malignancies, or systemic illnesses such as heart failure, kidney failure, or liver failure.
Bioavailability Study of Cretan Carob

This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of phenolic compounds of a beverage prepared with Cretan carob powder of the Imera cultivar in healthy individuals after consumption.

This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of active constituents of a beverage with carob powder in healthy individuals after consumption. Fifteen apparently healthy male adults of normal body fat mass (non-obese) will be enrolled based on certain inclusion and exclusion criteria. After enrollment, the volunteers will undergo a medical and dietary assessment and will be instructed to follow a low-phytochemical diet (washout) for five consecutive days, excluding from their diet sources of phytochemicals, i.e., fruits, vegetables, legumes, coffee, tea. Compliance with the low-phytochemical diet will be assessed with a 24 h recall during and at the end of the washout period. On the day of the experiment following washout, volunteers will be given a carob beverage (blood samples will be collected 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4-6 h postprandially). Time intervals 0-6h will be used for LC-ESI-MS/MS approach in order to identify putative polyphenol metabolites related to carob consumption.

Eligibility Criteria:
Inclusion Criteria:

* healthy male adults
* normal body fat mass

Exclusion Criteria:

* obesity (according to body fat mass)
* Type 1 Diabetes, cardiovascular diseases, hypertension
* thyroid disorder, liver disease, kidney disease
* gastrointestinal disease
* mental illness
* use of nutraceutical supplements or natural products for weight loss
* dietitians/nutritionists
The Diabetes Patient Takes Responsibility

People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an appointment with a nurse or doctor within defined time intervals via telephone, e-mail or apps. Patient-reported outcomes (patient satisfaction and experience, QoL) clinical variables (HbA1c, blood pressure etc.) and use of human resources (doctors, diabetes-nurses and diet physicians) are monitored.

This is a 24 month prospective randomized controlled trial. People with Type 1 diabetes (T1D) are randomized to two groups: (i) Patients randomized to the control group receive their standard diabetes care and are seen in the out-patient clinic with regular intervals (typically a diabetes nurse every 3-4 month and a diabetes doctor once a year. (ii) Patients randomized to the intervention group are not called for at fixed time points. They can arrange visits in the diabetes clinic whenever they feel the need to do so. The have a guarantee for a consultation with a diabetes nurse within one week and with a diabetes doctor or diet physician within two weeks. Questionnaires (a specific questionnaire focused on patient satisfaction developed for the study and AddQoL) are filled in at time 0 and 24 month. Blood samples for diabetes-related variables (HbA1c, lipid status), blood pressure, body weight etc. are likewise recorded at time 0 and 24 month. Economic and time requirements are evaluated at 24 month.

Eligibility Criteria:
Inclusion Criteria:

Type 1 diabetes 18 - 80 years Multiple injections or Insulin pump therapy

Exclusion Criteria:

Newly diagnosed T1D Psychiatric illness Need for translation Unstable conditions such as progressive retinopathy
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization

This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal, aged 18-42 old at time of consent
* At least one cycle without fertility medication prior to screening
* Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility
* Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)
* Others as indicated by FDA-approved protocol

Exclusion Criteria:

* Any contraindication to progesterone therapy
* BMI \> 38 kg/m2
* Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)
* History of more than 1 failed fresh IVF cycles
* More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)
* Others as indicated by FDA-approved protocol
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (PPD).


Eligibility Criteria:
Key Inclusion Criteria:

1. Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I Disorders (SCID-5).
2. Participant is ≤6 months postpartum at screening.

Key Exclusion Criteria:

1. Active psychosis
2. Attempted suicide during current episode of PPD
3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)

The purpose now is to:

1. identify brain connections related to proprioception to have a better understanding of differences between people with stroke and healthy persons
2. evaluate how these brain connections will change in people with stroke when they are engaged in 6-week cognitive multisensory rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for healthy subjects are:

* medically stable;
* 18 - 99 years of age;
* able to hear the instructions given during the study

Inclusion criteria for stroke patients are:

* at least 6 months post-stroke;
* medically stable;
* 18 - 99 years of age;
* subcortical or cortical infarct confirmed with MRI;
* Mini-mental State Exam \> 24/30 (Folstein et al., 1975);
* able to hear the instructions given during the study;
* able to comprehend the instructions given during the study;
* able to commit time to participate in a 6-12-weeks rehabilitation program

Exclusion Criteria:

* having ever experienced a stroke or another brain injury or illness related to the brain that has lasting effects or effects experienced at the moment of recruitment;
* severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt;
* contractures in tested arm that hinder persons from keeping the outstretched arm in a relaxed position;
* interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);
* exhibit contra-indications to enter the magnetic field of the 3T (pacemakers, metal parts in the body etc);
* pregnant or nursing mother;
* adults lacking capacity to consent
The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy

Effective bowel preparation is important for examination of the entire colon adequately and for identifying colonic lesions during colonoscopy. However, it is well known that bowel preparation of inpatients is much poorer than that of outpatients. Our goal is to improve bowel preparations with reinforcement of nurse education that explains the steps required for bowel preparation for inpatients undergoing colonoscopies. The education will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. Patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a explanation from reinforcement-educated nurse. The investigators hypothesize that patients received a explanation from reinforcement-educated nurses will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and patients' satisfaction for colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* all inpatients
* age \>18
* referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

* outpatients
* pregnancy
* breast feeding
* prior history of surgical large bowel resection
* patients allergic to PEG-ELS based laxatives
Race and the Use of Cardiovascular Surgical Procedures

To study the causes of persistent differences in Black-white access to tertiary care cardiovascular surgical services (TCCS).

BACKGROUND:

Cardiovascular disease is the leading cause of death among adults in the United States. Although not long ago it was widely believed that African-Americans had a lower incidence of cardiovascular disease than whites, few now believe this to be the case. However, despite parity in the incidence of cardiovascular disease, there remains a substantial Black-white difference in the utilization of tertiary care cardiovascular services (TCCS), such as coronary angiography (CA), coronary bypass surgery (CABG) and percutaneous transluminal coronary angioplasty (PTCA). Race differences have been found with great consistency across studies of varying design.

DESIGN NARRATIVE:

The study used a retrospective quasi-experimental population-based epidemiology design to examine the characteristics of the health care provider and the individual patient that account for utilization of TCCS. The study had four specific aims: 1) to determine the patient and provider characteristics exclusive of symptomatology that predict Black-white differences in referral for coronary angiography; 2) to determine, for patients who are referred for coronary angiography, the patient and provider characteristics that predict Black-white differences in receipt of coronary angiography; 3) to determine the patient and provider characteristics exclusive of symptomatology that predict Black-white difference in referral for CABG and PTCA; 4) to determine, for patients who are referred for CABG or PTCA, the patient and provider characteristics that predict Black-white differences in receipt of CABG and PTCA.

The hospital records of every 1996 cardiac discharge from each of three Baltimore-area hospitals are reviewed to assign each patient to one of three classes. These classes reflect the medical appropriateness of coronary angiography as estimated by the American College of Cardiology and the American Heart Association. All patients in class 1 (indicating general agreement that coronary angiography is indicated) are interviewed by telephone to ascertain barriers to utilization and other factors that may contribute to the use of services. In addition, a stratified sample of 16 class 1 subjects are interviewed in depth. An estimated 400 referring physicians are surveyed to develop a typology of physician practice patterns. Results from patient surveys, physician surveys, and medical record reviews are merged to form the analytical database.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor

The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.


Eligibility Criteria:
Inclusion:

* Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.
* Subject demonstrates reduced susceptibility to lopinavir.
* Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.
* The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.
* Subject is at least 18 years of age.
* Subject has not been treated for an active opportunistic infection within 30 days of screening.

Exclusion:

* Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.
* Female subject pregnant or lactating.
* Use of an Investigational drug within 30 days prior to the initiation of drug dosing.
* Subject is receiving systemic chemotherapy.
* Subject has a history of acute or chronic pancreatitis.
Patient Compliance With Long-Acting Reversible Contraception Administration

This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously done.

Randomized control trial with control group receiving LARC at 6 weeks postpartum and the study group receiving LARC in the immediate or early postpartum period. Outcomes will be measured by those who receive or do not receive LARC either in the hospital after delivery versus 6 weeks postpartum in accordance with the study subjects' randomized designation. Secondary outcomes of bleeding profile and satisfaction will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant, desires LARC postpartum

Exclusion Criteria:

* Medical contraindication to desired LARC, vaginal delivery complicated by fourth degree perineal laceration, history of pelvic inflammatory disease, uterine infection
Prevention of Breast Cancer-related Lymphedma With Tacrolimus

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Tacrolimus ointment may prevent lymphedema by inhibition of CD4+T cells.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Breast cancer with planned ALND
* postmenopausal or use of contraceptives
* good general health condition
* read and understand Danish

Exclusion Criteria:

* Pregnant, breastfeeding it wishing to conceive with the next year
* bilateral breast cancer
* known allergy to tacrolimus or macrolides
* known lymphedema
* other malignant disease apart from keratinocyte cancer
* in medical treatment for diabetes mellitus
* known psychiatric condition which may influence participation
* known renal or hepatic function
Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

The primary objective of this study is to determine the maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D), and safety and tolerability of zanubrutinib in combination with lenalidomide in participants with R/R DLBCL by dose escalating lenalidomide


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed DLBCL, all participants must provide sufficient archival or fresh tumor tissue samples for evaluation by immunohistochemistry (IHC) and Gene Expression Profiling (GEP).
2. Relapsed or refractory disease, defined as either: 1) progression of disease after having achieved disease remission (complete response \[CR\] or partial response \[PR\]) , or 2) stable disease (SD), or progressive disease (PD) at completion of the treatment regimen preceding entry to the study.
3. Participants who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
4. Measurable disease as defined by at least 1 lymph node \>1.5 cm in longest diameter, or at least 1 extra-nodal lesion \>1.0 cm in longest diameter, and measurable in 2 perpendicular dimensions.
5. Received an appropriate first-line therapy for DLBCL,defined as an anti CD20 antibody and an appropriate anthracycline-based combination therapy for at least 2 cycles, unless the patient is intolerant or had disease progression before Cycle 2..

Key Exclusion Criteria:

1. Current or history of central nervous system (CNS) lymphoma.
2. Histologically transformed lymphoma.
3. History of allogeneic stem-cell transplantation.
4. Prior exposure to a BTK inhibitor.
5. Prior exposure to lenalidomide or thalidomide.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.