cyrilzakka/clinical-trials huggingface dataset:
Motivations and Psychological Aspects of the Gametes' Donation

The main objective is to study donors' personality and motivations characteristics of the different recruitment methods and thus to answer questions related to the donation's approach, its representations as well as motivations and the profile of the donors.

The methodology used is mixed with a quantitative and qualitative approach. The first one is a psychosocial approach with two groups: donors of gametes without children, and donors who have already procreated. Two questionnaires will be used in this survey. The first aims to study the donors' socio-personal characteristics and motivations. The latter studies donors' personality traits.

The second approach is qualitative by a clinical case study. It is a psycho-dynamic approach, taking into consideration the donor (men and women), with all their subjectivity, their personal and family history and their representations.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for gametes donation
* Less than 45 years for men
* Less than 37 years for women
* Affiliation to social service

Exclusion Criteria:

* Under guardianship, or trusteeship
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area

Exclusion Criteria:

* Location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
* Treatment with ingenol mebutate gel in the treatment area within the last 12 months
* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
* History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)
Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery

The goal of this Prospective observational studiesis to Characteristics of progressive suction loss.

The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. The main question\[s\] it aims to answer are: • Characteristics of people who do not develop progressive aspiration Characteristics of people with progressive aspiration Participants will The differences between the two groups were compared

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Stable refractive state in the last 2 years, with yearly change in refractive power ≤ 0.50 D;
3. Spherical power ≤ -10.00D, cylindrical power ≤ -3.00 D;
4. Best Corrected Visual Acuity (BCVA) ≥ 16/20;
5. No use of corneal contact lenses two weeks before surgery.

Exclusion Criteria:

1. Eye diseases or histories beyond myopia and astigmatism, such as keratoconus;
2. Previous eye surgeries or histories of systemic illnesses;
3. Severe mental disorders like generalized anxiety disorder, panic disorder, depression, psychosis, and bipolar disorder, impeding cooperation with the doctor.
The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer

Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of stage III colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging


Eligibility Criteria:
Inclusion Criteria:

* age \&gt; 18 years,
* confirmed diagnosis of primary CRC,
* preoperative tumor stage of cT1 to cT4, N+, M0 as determined by contrast-enhanced computed tomography (CT),
* no distant metastasis, and
* American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3

Exclusion Criteria:

* history of previous colorectal surgery, emergent surgery, or palliative resection;
* pregnancy or breastfeeding;
* allergy or history of an adverse reaction to ICG
* severe mental disorder.
The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection

This research is being done to study the ability of C. difficile to colonize the colonic mucosa of individuals with no prior history of C. difficile infection.

The ability of C. difficile to colonize the mucosa of the colon will be studied in healthy individuals with no history of C. difficile infection who are undergoing colonoscopy for colon cancer/polyp screening purposes.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over
* No history of C. difficile infection
* Undergoing clinically indicated colonoscopy for colon cancer screening or colon polyp surveillance purposes in the absence of active GI symptoms.

Exclusion Criteria:

* Known active pregnancy
* Other known active gastrointestinal infectious process
* Inflammatory gastrointestinal conditions (microscopic colitis, inflammatory bowel disease, Celiac disease)
* Vulnerable adults
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
COmpliance and Efficacy in Mono and Combination Tablet Study ATacand/Atacand Plus

To evaluate compliance and patients' satisfaction in mono and combination treatment of Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg (Atacand plus) in hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have consented to participation/data release in this study
2. Patients diagnosed with hypertension and prescribed with atacand/atacand plus by the physician based on clinical decision

Exclusion Criteria:

1. Secondary hypertension requiring therapy other than antihypertensive medication
2. Patients not prescribed with atacand/atacand plus based on safety reasons or any other reason as determined by the physician
3. Women in pregnancy or lactation
4. Patients enrolled in any other studies
Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders

The aim of this study was to assess the electrical activity of the temporal and masseter muscles in cleft lip and palate (CLP) children with pain-related temporomandibular disorders (TMD) and in CLP individuals with no TMD by means of surface electromyography (sEMG). Another objective was to determine the diagnostic value of electromyography in identifying CLP patients with temporomandibular disorders. The sample comprised 87 children with CLP and mixed dentition. The children were assessed for the presence of TMD using of the Research Diagnostic Criteria for TMD (RDC/TMD) by a single examiner. A DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the temporal and masseter muscles both in the mandibular rest position and during maximum voluntary contraction (MVC).


Eligibility Criteria:
Inclusion Criteria:

* presence of a cleft without a syndrome, a sequence, or karyotype abnormalities
* presence of mixed dentition

Exclusion Criteria:

* the presence of systemic or rheumatologic diseases
* a history of cervical spine or temporomandibular joint (TMJ) surgery, trauma or malformations
Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of primary immune thrombocytopenia (ITP) for a minimum of 3 months prior to Screening Visit
* Subject has a platelet count \<30x10\^9/L at Screening and \<35x10\^9/L at Baseline (Visit 2)
* Subject has a current or history of a peripheral blood smear consistent with ITP
* Subject has responded to previous ITP therapy (according to the judgment of the investigator)

Exclusion Criteria:

* Subject has an immunoglobulin G (IgG) level \<=6g/L at Screening Visit
* Subject has a partial thromboplastin time (PTT) \>=1.5x upper limit of normal (ULN) or International Normalized Ratio (INR) \>=1.5 at Screening Visit
* Subject has renal and/or liver impairment defined as:

  * Serum creatinine level of \>=1.4 mg/dL for females and \>=1.5 mg/dL for males at Screening Visit
* Subject has planned an elective surgical procedure in the coming 6 months
* Subject has evidence of a secondary cause of primary immune thrombocytopenia purpura
* Subject has a history of clinically relevant ongoing chronic infections
* Subject has a family history of primary immunodeficiency
* Subject has a clinically relevant active infection or has had a serious infection within 6 weeks prior to the first dose of IMP
* Subject has a history of known inflammatory bowel disease, diverticular disease, and gastric or esophageal ulceration
* Subject has experienced gastrointestinal bleed in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis
* Subject has a medical history of thrombosis
* Subject has a history of coagulopathy disorders other than ITP
* Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
* Subject has had prior treatment with rituximab in the 6 months prior to the Baseline Visit
* Subject has not completed the washout period for the immunosuppressants, biologics and other therapies
Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis

Primary aldosteronism (PA) is the excessive endogenous production of the mineralocorticoid aldosterone. Although various rare forms of PA exist, the vast majority of cases are accounted by either an aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia. During the last decades the prevalence of PA has risen, predominantly due to better awareness of disease. Several studies estimated a prevalence of PA up to 17% in an unselected population of hypertensive patients. However, in a population with resistant hypertension the reported prevalence is even higher: 17-23%. This emphasizes the clinical impact of PA on morbidity and mortality due to high blood pressure. Since both hypertension and aldosteronism are independent risk factors for cardiovascular morbidity, the aim of treatment is curation or reduction of both.

After an adrenalectomy for APA normalization of biochemical abnormalities is achieved in almost all cases. Nevertheless, curation of hypertension (systolic blood pressure \<140 and diastolic blood pressure \<90 mmHg) without the need of antihypertensive medication is accomplished in only 35-45% of the cases. In 2008 the Aldosteronoma Resolution Score (ARS) was developed. This score predicts the likelihood of complete resolution of the hypertension in patients with an aldosteronoma and has been validated by other investigator groups.

Reduction of hypertension is also an important clinical outcome and is reported in 90-98% of the patients after surgery. In most studies reduction is defined as a certain decrease in blood pressure or antihypertensive medication. However, there is no consensus on the precise definition of reduction in these patients, which leads to incomparable results.

The aim of the proposed study is to determine the proportion of patients with clinically relevant reduction of hypertension after adrenalectomy in a large cohort. Furthermore, the investigators aim to determine the characteristics predicting this clinically relevant reduction. Additionally, the investigators evaluate the predictive value of the Aldosteronoma Resolution Score for clinically relevant reduction and aim to develop a scoring system to help clinicians predict the likelihood of reduction of hypertension after adrenalectomy so it can be used for patient counseling.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent unilateral adrenalectomy between 2010 and 2016 for APA.
* Patients with biochemical evidence of primary aldosteronism who underwent adrenalectomy on account of an aldosterone-producing adenoma(APA), proven by Computerized Tomography(CT) or Magnetic Resonance Imaging(MRI) or Adrenal Venous Sampling(AVS).

Exclusion Criteria:

* Age \<18 years.
* Missing or incomplete data about preoperative blood pressure and number of antihypertensive drugs.
* Missing or incomplete follow-up data about postoperative blood pressure and number of antihypertensive drugs. We aim enter the blood pressure and number of antihypertensive drugs closest to 6 months after adrenalectomy.
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

This study is an open label extension study, which means that the participants from the Lead-in Study 19140A (NCT04921384) can join this study, if they meet the study Eligibility Criteria, and continue to receive the study drug eptinezumab. The main goal of this study is to investigate long-term safety and tolerability of eptinezumab in Japanese migraine participants.

The total study duration from the Baseline Visit to the Safety Follow-up Visit is approximately 68 weeks and includes an Open-Label Treatment Period (60 weeks) and a Safety Follow-up Period (8 weeks).

Eligibility Criteria:
Key Inclusion Criteria:

* The participant has completed the Primary Outcome Visit (Visit 5) of the lead-in Study 19140A immediately prior to enrolment into this study.
* The participant is indicated for 60-week preventive treatment of chronic migraine with eptinezumab according to the clinical opinion of the investigator.

Key Exclusion Criteria:

* The participant has a serious adverse event (SAE) or a moderate or severe ongoing AE from the Lead-In study considered a potential safety risk by the investigator.
* The participant has a clinically relevant change in vital signs or electrocardiogram (ECG) from the Lead-In study considered a potential safety risk by the investigator.
* The participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.

Other inclusion and exclusion criteria may apply.
A Study of JNJ-64300535 in Healthy Participants

The purpose of this study is to evaluate the cellular immunogenicity of 3 monthly electroporation-mediated intramuscular (IM) injections of JNJ-64300535 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent form (ICF) indicating that he understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Must be healthy as confirmed by medical history, physical examination, and vital signs performed at screening

Exclusion Criteria:

* Weight of less than (\<) 50 kilograms (kg) and a body mass index (BMI) \<19.0 or greater than (\>) 29.9 kilogram per meter square (kg/m\^2) at screening
* History of Human Immunodeficiency Virus (HIV) infection or a positive HIV antibody test at screening
* History of HBV infection, measured by the presence of HBsAg and/or anti-HBc antibodies
* History of seizure disorders unless seizure free for \>5 years
* Has a non-removable active electronic stimulation device
Text Message Support to Prevent Smoking Relapse

The purpose of this research is to test a text message intervention for people who are beginning an attempt to quit smoking. The intervention seeks to teach people to think about their cravings to smoke in more helpful ways. The investigators expect that participants receiving the text message craving program will be less likely to begin smoking again compared to participants in a control condition.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Current daily smoking defined as smoking ≥5 cigarettes per day and having smoked for at least 3 months. During the first visit smoking status will be verified by a Carbon Monoxide level of at least 8 parts per million.
* Have a mobile phone and use text messaging at least monthly
* Be planning to quit smoking without pharmacological help.

Exclusion Criteria:

* Significant cognitive impairment
* Current therapy or pharmacological intervention for smoking or nicotine cravings
* Inability to read English
Clinical Outcome and Cytokine Expression After TKA

Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results

Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results at 3 months, 1 year and 3 years after surgery

Eligibility Criteria:
Inclusion Criteria:

* Primary and secondary osteoarthritis
* understanding of german language

Exclusion Criteria:

* necessity of constrained TKA
* existence of other joint implants
Vacuum Assisted Closure as a Treatment for Draining Hematomas

This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating draining hematomas following traumatic injury.

Application of the VAC device may significantly decrease the incidence of draining hematomas that require surgical irrigation and debridement. The aim of this project is to perform a prospective, randomized study evaluating the VAC negative pressure device as a treatment for draining hematomas. We will also analyze the cost of treating a hematoma with a VAC compared with currently employed treatments. Additionally, we will document the incidence of infection of the hematoma with and without use of the VAC device.

Patients who have a draining hematoma five days following surgery and who give informed consent to enter the study will be randomized into two groups. Group A will be patients treated with a pressure dressing and observation, which is the most common current method of treatment. Group B will be patients treated with a VAC negative pressure device. Patients will be carefully monitored for continued drainage by evaluating the wounds and dressings clinically. Patients in either group that are still draining at ten days following surgery will be taken to the operating room for irrigation and debridement. Patients in either group who develop infection will be immediately treated with irrigation and debridement.

Eligibility Criteria:
Inclusion Criteria:

* Patient who has had an orthopaedic surgical procedure following trauma and has a draining wound for at least five days
* No clinical evidence of infection
* Adult patient (19 years and older)

Exclusion Criteria:

* An infected hematoma. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any hematomas that are thought to be infected will be cultured to confirm the diagnosis
* A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such Tegaderm) to achieve a closed vacuum environment over the wound
* Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
* Abnormal coagulation leading to an expanding hematoma that will require surgical debridements
* Prisoners
* Pregnant Women
* Inability to comply with protocol
* Patients or family members who are unable or unwilling to sign study consent
Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem

The aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the proximal femur after implantation of the Fitmore compared to the CLS stem.

After power analysis, 140 consecutive patients were prospectively included in the randomisation protocol receiving either a Fitmore short or a CLS straight stem. The short stem was assigned in 57 (37% females) cases and the straight stem in 83 (38% females) hips. Periprosthetic bone mineral density was measured before surgery, 7 days, 3, 12 and 60 months postoperatively, using dual energy x-ray absorptiometry (DEXA). The results of the first postoperative measurement served as the baseline value. Because of the different length of the two prostheses we used adapted Gruen zones to divide the periprosthetic bone in seven regions of interest (ROI) with equal length in the proximal zones 1,2,6 and 7, only the regions 3 and 5 featured different sizes. Clinical results were recorded using the WOMAC and the Harris hip score (HHS).

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary osteoarthritis of the hip
* written informed consent
* indication for cementless total hip arthroplasty

Exclusion Criteria:

* previous surgery in the same hip
* femoral fracture
* metabolic bone disease
* drugs affecting bone quality
* contralateral THA within the study period
* infectious disease or bony tumor
Diabetic Autonomic Neuropathy and Left Ventricular Function

Purpose: To investigate the effect of Quinapril (Q) or Losartan (L) or their combination on definite Diabetic Autonomic Neuropathy (DAN) and left ventricular systolic and diastolic function (LVF) over a period of 4 years.

Patients-methods: Fifty-nine patients with definite DAN \[2 or more of the 4 Cardiovascular Reflex Tests (CRTs) were abnormal\] were studied for 4 years. Patients were randomly allocated in 3 groups receiving A, 20 mg Q, B, 100 mg L and C, 20 mg Q +100 mg L respectively. CRTs analyzed with Mean Circular Resultant (MCR), Valsalva index, 30:15 ratio and postural hypotension. LV function was investigated with radionuclide ventriculography (RNV) at rest. Ejection fraction was used to assess LV systolic function, while peak filling rate, first third filling fraction, and atrial contribution to ventricular filling were used to investigate LV diastolic function. CRTs and RNV were performed at baseline and after 4 years.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old
2. Diabetes mellitus
3. Diabetic autonomic neuropathy

Exclusion Criteria:

1. Coronary artery disease
2. Arterial hypertension
3. Heart failure with reduced ejection fraction LVEF\<40%
4. Any contraindication to undergo radionuclide ventriculography